Ibrance

(Palbociclib)

ApprovedSmall molecule

Palbociclib is used to treat certain types of breast cancer, particularly hormone receptor-positive breast cancer in women. It works by slowing down the growth of cancer cells by blocking proteins that help them divide.[2] Ibrance is currently approved and in use across 63 indications[4].[1]

Ibrance is one of 1071 small molecule programs targeting Bone Metastasis. It is currently in Approved.

Indications

301

Total Trials

Active Trials

1,070

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Bone MetastasisActive, not recruiting

ChordomaActive, not recruiting

Non-Hodgkins LymphomaApproved

Breast DiseaseApproved

Esophageal Squamous Cell CarcinomaActive, not recruiting

Nasopharyngeal CarcinomaApproved

Lung CancerActive, not recruiting

Thymus NeoplasmApproved

Tic DisorderActive, not recruiting

LymphomaApproved

Bone MetastasisPhase 2

Active, not recruiting

ChordomaPhase 2

Active, not recruiting

Non-Hodgkins LymphomaApproved

Approved

Breast DiseaseApproved

Approved

Esophageal Squamous Cell CarcinomaPhase 2

Active, not recruiting

Nasopharyngeal CarcinomaApproved

Approved

Lung CancerPhase 2

Active, not recruiting

Thymus NeoplasmApproved

Approved

Tic DisorderPhase 2

Active, not recruiting

LymphomaApproved

Approved

Showing 10 of 63 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Ibrance

DATROWAY

4 3

Cymbalta

Alnylam Pharmaceuticals

Preclinical

3 4

Voltaren

Novartis

Preclinical

1 5

Lupron

EEastern Cooperative Oncology Group

Preclinical

5 6

Effexor

WWyeth-Lederle Vaccines

Preclinical

2 7

Spravato

WWim Janssens

Preclinical

2 8

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 9

Aquasol E

NNational Eye Institute (NEI)

Preclinical

—10

Vfend

PPrism Pharmaceuticals

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 3Active, not recruiting

Breast Cancer

NCT02947685

Phase 1Active, not recruiting

Breast Cancer

NCT03332797

Phase 1Recruiting

Breast Cancer

NCT04360941

Phase 2Active, not recruiting

Treatment

NCT05554367

Phase 2Recruiting

Breast Cancer

NCT04920708

Not yet recruiting

Breast Cancer

NCT06338644

Clinical

Trials by Indication[1]

Breast Cancer83 trials

First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast Cancer

Recruiting· Relay Therapeutics logo

Relay Therapeutics·Phase 1·NCT05216432·930 enrolled

Neoadjuvant Biomarker ResearcH Study of Palbociclib Combined With Endocrine Therapy in Estrogen Receptor Positive/HER2 Negative Breast CAncer (NeoRHEA)

Completed·JJules Bordet Institute·Phase 2·NCT03065621·100 enrolled

Palbociclib for HR Positive / HER2-negative Isolated Locoregional Recurrence of Breast Cancer

Active, not recruiting·EETOP IBCSG Partners Foundation·Phase 3·NCT03820830·405 enrolled

Show 80 more trials

Fulvestrant Versus Fulvestrant Plus Palbociclib in Operable Breast Cancer Responding to Fulvestrant

Completed·IInternational Cancer Research Group, United Arab Emirates·Phase 3·NCT03447132·354 enrolled

Fulvestrant, Ipatasertib and CDK4/6 Inhibition in Metastatic ER+/HER2- Breast Cancer Patients Without ctDNA Suppression

Recruiting·RRoyal Marsden NHS Foundation Trust·Phase 2·NCT04920708·324 enrolled

A Study of H3B-6545 in Combination With Palbociclib in Women With Advanced or Metastatic Estrogen Receptor-Positive Human Epidermal Growth Factor Receptor-2 (HER2)-Negative Breast Cancer

Active, not recruiting· Eisai logo

Eisai·Phase 1·NCT04288089·31 enrolled

A Study of Sirolimus (Albumin-Bound) in Combination With Palbociclib and Fulvestrant for the Treatment of Advanced Breast Cancer

Not yet recruiting· CSPC ZhongQi Pharmaceutical Technology Co., Ltd. logo

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.·Phase 1·NCT06941142·382 enrolled

Two Different Schedules of Palbociclib + Second Line Endocrine Therapy in Estrogen Receptor Positive, HER2 Neg Advanced/Metastatic Breast Cancer

Completed·CCanadian Cancer Trials Group·Phase 2·NCT02630693·180 enrolled

CIMER: Combined Immunotherapies in Metastatic ER+ Breast Cancer

Withdrawn·WWeill Medical College of Cornell University·Phase 2·NCT04220476

Combined Immunotherapies in Metastatic ER+ Breast Cancer

Recruiting·WWeill Medical College of Cornell University·Phase 2·NCT04563507·102 enrolled

Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive, HER2 Negative Invasive Breast Cancer

Completed·—·Phase 2·NCT02040857·162 enrolled

A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)

Active, not recruiting· Roche logo

Roche·Phase 3·NCT04546009·992 enrolled

First-line Palbociclib and Endocrine Therapy for Patients With HR+/HER2- Advanced Breast Cancer in the Real-world Setting.

Active, not recruiting· Pfizer logo

Pfizer··NCT04767594·1,409 enrolled

Evaluation of Geriatric Questionnaires to Predict Toxicities of CDK 4/6 Inhibitors in Older Breast Cancer Patients?

Unknown status·NNamik Kemal University··NCT05051956·140 enrolled

Palbociclib Combined With an Aromatase Inhibitor in Breast Cancer

Unknown status·SShengjing Hospital·Phase 3·NCT04047758·420 enrolled

A Study to Describe the Breast Cancer Patient Population, Treatment, and Results in Indian Patients Receiving Combinations of the Medicines Called Palbociclib for Advanced Breast Cancer

Completed· Pfizer logo

Pfizer··NCT05584644·150 enrolled

Effectiveness and Safety of Palbociclib: Brand vs. Generic in Iraqi Stage IV Hormone Receptor-positive / Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer Patients: A Comparative Study

Active, not recruiting·—··NCT07493291·100 enrolled

Palbociclib / Letrozole or Fulvestrant in African American Women With HR+ HER2- Breast Cancer

Completed·GGeorgetown University·Phase 2/3·NCT02692755·35 enrolled

A Trial of Early Detection of Molecular Relapse With Circulating Tumour DNA Tracking and Treatment With Palbociclib Plus Fulvestrant Versus Standard Endocrine Therapy in Patients With ER Positive HER2 Negative Breast Cancer

Recruiting·RRoyal Marsden NHS Foundation Trust·Phase 2·NCT04985266·1,100 enrolled

A Study of HR+/HER2- Metastatic Breast Cancer Patients Treated With Palbociclib Together With an Aromatase Inhibitor From 2017 to 2023 in Denmark.

Completed· Pfizer logo

Pfizer··NCT06307457·604 enrolled

Palbociclib, Trastuzumab,Pyrotinib and Fulvestrant Treatment in Patients With Brain Metastasis From ER/PR Positive, HER-2 Positive Breast Cancer: A Multi-center, Prospective Study in China

Unknown status·SSun Yat-sen University·Phase 2·NCT04334330·34 enrolled

Comparative Real World Tumor Response in Pre-menopausal Metastatic Breast Cancer Patients Treated With Palbociclib + Aromatase Inhibitor or Aromatase Inhibitor Alone

Completed· Pfizer logo

Pfizer··NCT05012644·197 enrolled

Neoadjuvant Treatment With Palbociclib and Exemestane Plus Trastuzumab and Pyrotinib in Estrogen Receptor (ER)-Positive, HER2-positive Breast Cancer

Unknown status·GGuangdong Provincial People's Hospital·Phase 2·NCT04858516·57 enrolled

Treatment Patterns and Clinical Outcomes Among Patients Receiving Palbociclib Combinations for Hormone Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2 ) Advanced/Metastatic Breast Cancer in the Arabian Gulf Region

Completed· Pfizer logo

Pfizer··NCT04916509·258 enrolled

Endocrine Therapy Fulvestrant & Palbociclib or Aromatase Inhibitor Therapy in Treating Older Patients With Hormone Responsive Breast Cancer That Cannot Be Removed by Surgery

Completed·OOhio State University Comprehensive Cancer Center·Phase 2·NCT02760030·14 enrolled

Efficacy of Letrozole + Palbociclib Combination as Neoadjuvant Treatment of Stage II-IIIA PAM 50 ROR-defined Low or Intermediate Risk Luminal Breast Cancer, in Postmenopausal Women

Completed·UUNICANCER·Phase 2·NCT02400567·125 enrolled

Palbociclib in Combination With Fulvestrant Versus Fulvestrant in Advanced Breast Cancer: A Real-world Study in China

Unknown status·TTianjin Medical University Cancer Institute and Hospital··NCT04526028·612 enrolled

Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease

Recruiting· Pfizer logo

Pfizer·Phase 3·NCT06760637·1,020 enrolled

Neoadjuvant Hormonal Therapy Plus Palbociclib in Operable, Hormone Sensitive and HER2-Negative Primary Breast Cancer

Completed·KKyoto Breast Cancer Research Network·Phase 3·NCT03969121·141 enrolled

Predicting clinicAL outcoMes During First-line CDK4/6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study

Recruiting·FFondazione IRCCS Istituto Nazionale dei Tumori, Milano··NCT06805812·3,500 enrolled

Aromatase Inhibitor Therapy With or Without Fulvestrant for the Treatment of HR Positive Metastatic Breast Cancer With an ERS1 Activating Mutation, the INTERACT Study

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT04256941·4 enrolled

The Combination of Palbociclib With ddEC-P as Neoadjuvant Therapy in Triple Negative Breast Cancer

Unknown status·ZZhejiang Cancer Hospital·N/A·NCT03756090·100 enrolled

WI231696: Bosutinib, Palbocicilib and Fulvestrant for HR+HER2- Advanced Breast Cancer Refractory to a CDK4/6 Inhibitor

Completed·GGeorgetown University·Phase 1·NCT03854903·19 enrolled

A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer

Completed·CCelcuity Inc·Phase 1·NCT02684032·141 enrolled

Adjuvant Palbociclib in Elderly Patients With Breast Cancer

Active, not recruiting·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT03609047·366 enrolled

Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer

Active, not recruiting·AAlliance Foundation Trials, LLC.·Phase 3·NCT02947685·518 enrolled

To Reduce the Use of Chemotherapy in Postmenopausal Patients With ER-positive and HER2-positive Breast Cancer (TOUCH)

Completed·EETOP IBCSG Partners Foundation·Phase 2·NCT03644186·147 enrolled

Phase 1/2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer

Terminated· Sanofi logo

Sanofi·Phase 1/2·NCT03284957·136 enrolled

PALbociclib Rechallenge in horMone Receptor-posItive/HER2- Negative Advanced Breast Cancer (PALMIRA)

Completed·MMedSIR·Phase 2·NCT03809988·198 enrolled

A Study of ZN-c5 in Subjects With Breast Cancer

Completed·ZZeno Alpha Inc.·Phase 1/2·NCT03560531·181 enrolled

Expanded Access Study Of Palbociclib (PD-0332991) In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR-Positive, Her2-Negative Advanced Breast Cancer For Whom Letrozole Therapy Is Deemed Appropriate

No longer available· Pfizer logo

Pfizer··NCT02142868

A Phase II Randomized Study Evaluating the Biological and Clinical Effects of the Combination of Palbociclib With Letrozole as Neoadjuvant Therapy in Post-Menopausal Women With Estrogen-Receptor Positive Primary Breast Cancer

Completed·NNSABP Foundation Inc·Phase 2·NCT02296801·307 enrolled

Pembrolizumab, Endocrine Therapy, and Palbociclib in Treating Postmenopausal Patients With Newly Diagnosed Metastatic Stage IV Estrogen Receptor Positive Breast Cancer

Active, not recruiting·—·Phase 2·NCT02778685·47 enrolled

Trial of Anastrozole and Palbociclib in Metastatic HER2-Negative Breast Cancer

Active, not recruiting·WWake Forest University Health Sciences·Phase 2·NCT02942355·40 enrolled

A Real-world Analysis of Concomitant Medication Use Among Metastatic Breast Cancer Patients Treated With CDK4/6 Inhibitors

Completed· Novartis logo

Novartis··NCT05141240·4,650 enrolled

Predicted Biomarkers of CDK4/6 Inhibitors (Palbociclib) in ER-positive Metastasis Breast Cancer

Unknown status·CChinese Academy of Medical Sciences··NCT04289974·100 enrolled

A Study to Investigate the Safety, Tolerability, of APG-2575 as a Single Agent or in Combination for Breast Cancer

Suspended· Ascentage Pharma Group Inc. logo

Ascentage Pharma Group Inc.·Phase 1/2·NCT04946864·65 enrolled

ER+/HER2- Locally Advanced or Metastatic Breast Cancer (ENZENO Study)

Unknown status·EEnhancedBio USA Inc.·Phase 1/2·NCT04669587·106 enrolled

AKT Inhibitor, Ipatasertib, With Endocrine and CDK 4/6 Inhibitor for Patients With Metastatic Breast Cancer (TAKTIC)

Active, not recruiting·MMassachusetts General Hospital·Phase 1·NCT03959891·77 enrolled

PalbocIclib in PreMenopausal Women With ER Positive/HER-2 Negative MetAstatic Breast Cancer

Unknown status·—·Phase 2·NCT02917005·160 enrolled

Hydroxychloroquine, Palbociclib, and Letrozole Before Surgery in Treating Patients With Estrogen Receptor Positive, HER2 Negative Breast Cancer

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT03774472·15 enrolled

A Study of GDC-9545 Alone or in Combination With Palbociclib and/or Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Locally Advanced or Metastatic Estrogen Receptor-Positive Breast Cancer

Active, not recruiting· Roche logo

Roche·Phase 1·NCT03332797·181 enrolled

PAveMenT: Palbociclib and Avelumab in Metastatic AR+ Triple Negative Breast Cancer

Recruiting·RRoyal Marsden NHS Foundation Trust·Phase 1·NCT04360941·45 enrolled

Palbociclib in Treating Patients With Metastatic HER-2 Positive Breast Cancer With Brain Metastasis

Terminated·NNorthwestern University·Phase 2·NCT02774681·12 enrolled

A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer

Recruiting· Roche logo

Roche·Phase 1/2·NCT03424005·792 enrolled

Palbociclib Pharmacokinetics Study In Postmenopausal Chinese Women With ER (+), HER2 (-) Advanced Breast Cancer

Completed· Pfizer logo

Pfizer·Phase 1·NCT02499146·26 enrolled

A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT04711252·1,370 enrolled

Palbociclib in Combination With Fulvestrant or Letrozole in Patients With ER+, HER2- Advanced Breast Cancer

Completed·MMedSIR·Phase 2·NCT02491983·486 enrolled

To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer

Active, not recruiting· Roche logo

Roche·Phase 1·NCT03006172·200 enrolled

A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients

Active, not recruiting·OOlema Pharmaceuticals, Inc.·Phase 1·NCT05266105·60 enrolled

Study in Women With Advanced Breast Cancer Receiving Palbociclib With AI or Fulvestrant

Completed·IiOMEDICO AG·Phase 2·NCT02894398·388 enrolled

Phase 1b/2 Study of TTI-101 in Combination for Patients With Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer

Terminated·TTvardi Therapeutics, Incorporated·Phase 1·NCT05384119·6 enrolled

Phase I Study of Combination of Gedatolisib With Palbociclib and Faslodex in Patients With ER+/HER2- Breast Cancer

Unknown status·HHoffman Oncology·Phase 1·NCT02626507·18 enrolled

A Study of GDC-0810 Single Agent or in Combination With Palbociclib and/or a Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer

Terminated· Roche logo

Roche·Phase 1/2·NCT01823835·152 enrolled

Study of AZD2014 and Palbociclib in Patients With Estrogen Receptor Positive (ER+) Metastatic Breast Cancer

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT02599714·54 enrolled

Stereotactic Radiosurgery With Abemaciclib, Ribociclib, or Palbociclib in Treating Patients With Hormone Receptor Positive Breast Cancer With Brain Metastases

Withdrawn·EEmory University·Phase 1·NCT04585724

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Giredestrant Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer (coopERA Breast Cancer)

Completed· Roche logo

Roche·Phase 2·NCT04436744·221 enrolled

High Risk ER+HER2- T1-2N0-1 Early Breast Cancer With Palbociclib Plus Endocrine Therapy(HIPEx)

Unknown status·SSamsung Medical Center·Phase 2·NCT04247633·578 enrolled

A Study of Palbociclib in Combination With Bazedoxifene in Hormone Receptor Positive Breast Cancer

Completed·—·Phase 1/2·NCT02448771·36 enrolled

A Real-life Study to Understand the Use and Effects of Palbociclib in US Patients With Breast Cancer

Active, not recruiting· Pfizer logo

Pfizer··NCT06495164·1 enrolled

Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)

Active, not recruiting·CCelcuity Inc·Phase 3·NCT05501886·701 enrolled

Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer

Completed· Pfizer logo

Pfizer·Phase 4·NCT02679755·252 enrolled

A Study of Letrozole, Palbociclib, and Onapristone ER in People With Metastatic Breast Cancer

Withdrawn·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT04872608

Fulvestrant and Palbociclib With or Without Copanlisib in Treating Patients With Hormone Receptor Positive, HER2 Negative, Stage IV Breast Cancer

Withdrawn·NNational Cancer Institute (NCI)·Phase 2·NCT03377101

PAlbociclib Plus Tamoxifen for the Treatment of Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Women - Asian studY

Active, not recruiting·NNational Cancer Center, Japan·Phase 3·NCT03423199·180 enrolled

Study of CYH33 in Combination With Endocrine Therapy With or Without Palbociclib in Patients With HR+, HER2- Advanced Breast Cancer

Unknown status·HHaihe Biopharma Co., Ltd.·Phase 1·NCT04856371·228 enrolled

A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer [PALOMA-4]

Completed· Pfizer logo

Pfizer·Phase 3·NCT02297438·340 enrolled

Palbociclib in Metastatic Breast Cancer: Gene Polymorphism-based Study in Egyptian Patients.

Not yet recruiting·HHelwan University··NCT06338644·100 enrolled

Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer

Completed·—·Phase 2·NCT02668666·49 enrolled

Analysis of Palbociclib Treatment in Patients With Advanced Breast Cancer Within a Compassionate Use Programe

Completed·FFernando Moreno Antón··NCT04109261·237 enrolled

ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer

Active, not recruiting· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 1·NCT06570031·46 enrolled

Fulvestrant, Palbociclib and Erdafitinib in ER+/HER2-/FGFR-amplified Metastatic Breast Cancer

Completed·VVanderbilt-Ingram Cancer Center·Phase 1·NCT03238196·35 enrolled

Study of Palbociclib and Trastuzumab With Endocrine Therapy in HER2-positive Metastatic Breast Cancer

Completed·SSOLTI Breast Cancer Research Group·Phase 2·NCT02448420·73 enrolled

Treatment5 trials

Precision Medicine Trial Based on Molecular Matching Therapy for Patients With Standard Treatment Exhaustion

Recruiting·TTianjin Medical University Second Hospital·Phase 2·NCT06739395·300 enrolled

Palbociclib and Binimetinib in RAS-Mutant Cancers, A ComboMATCH Treatment Trial

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05554367·199 enrolled

SMMART Adaptive Clinical Treatment (ACT) Trial

Withdrawn·OOHSU Knight Cancer Institute·Phase 1·NCT05238831

Show 2 more trials

A Study to Understand the Treatment Patterns and Patients and Their Clinical Outcomes Who Are Taking Palbociclib in a Real Life Setting in Israel.

Completed· Pfizer logo

Pfizer··NCT04671615·559 enrolled

Testing Palbociclib (PD-0332991) as Potentially Targeting Treatment in Cancers With CDK4 or CDK6 Amplification (MATCH - Subprotocol Z1C)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06390839·43 enrolled

Trial4 trials

Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR)

Recruiting·CCanadian Cancer Trials Group·Phase 2·NCT03297606·720 enrolled

The Drug Rediscovery Protocol (DRUP Trial)

Recruiting·TThe Netherlands Cancer Institute·Phase 2·NCT02925234·1,550 enrolled

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Terminated·OOHSU Knight Cancer Institute·Phase 1·NCT03878524·2 enrolled

Show 1 more trial

CARE Initiative: Real-world Emulation of the PALOMA-2 Trial

Completed·AAetion, Inc.··NCT06607601·724 enrolled

Effectiveness4 trials

Real-World Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor

Completed· Pfizer logo

Pfizer··NCT05361655·2,888 enrolled

Comparative Effectiveness of Palbociclib Plus AI Versus Fulvestrant for HR+/HER2- ABC

Unknown status·CChinese Academy of Medical Sciences··NCT05000736·600 enrolled

Comparative Effectiveness of PAL Based-therapy as Initial ET Versus PAL Based-therapy After ChT for HR+/HER2- ABC

Unknown status·CChinese Academy of Medical Sciences··NCT05343117·400 enrolled

Show 1 more trial

Real-world Treatment Patterns and Effectiveness of Palbociclib and AI Therapy

Completed· Pfizer logo

Pfizer··NCT04176354·813 enrolled

Advanced Solid Tumors4 trials

SNV4818 in Participants With Advanced Solid Tumors

Recruiting·PPikavation Therapeutics, Inc.·Phase 1/2·NCT06736704·320 enrolled

Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

Active, not recruiting· Amgen logo

Amgen·Phase 1·NCT04185883·610 enrolled

Study of INCB123667 in Subjects With Advanced Solid Tumors

Recruiting· Incyte logo

Incyte·Phase 1·NCT05238922·604 enrolled

Show 1 more trial

Palbociclib With Cisplatin or Carboplatin in Advanced Solid Tumors

Completed·EEmory University·Phase 1·NCT02897375·71 enrolled

78 more indications

Endocrine Therapy3 trials

Clinical Trial Assessing the Safety of Neoadjuvant Palbociclib in Combination With Endocrine Therapy

Active, not recruiting·UUniversity of Nebraska·Phase 2·NCT05069038·51 enrolled

Patterns of Treatment and Outcome of Palbociclib Plus Endocrine Therapy

Completed·IIstituti Clinici Scientifici Maugeri SpA··NCT04524728·191 enrolled

Phase III Palbociclib With Endocrine Therapy vs. Capecitabine in HR+/HER2- MBC With Resistance to Aromatase Inhibitors

Completed·SSpanish Breast Cancer Research Group·Phase 3·NCT02028507·693 enrolled

Overall Survival3 trials

Study to Evaluate the Extended Overall Survival (OS) Data From PARSIFAL Study (The PARSIFAL-LONG Study)

Completed·MMedSIR··NCT06525675·419 enrolled

Study to Evaluate Overall Survival in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Letrozole

Completed· Pfizer logo

Pfizer··NCT04735367·42 enrolled

Study to Compare Overall Survival in Medicare Patients With Metastatic Breast Cancer Treated With a Medicine Called Palbociclib in Combination With Aromatase Inhibitor and Aromatase Inhibitor by Itself.

Completed· Pfizer logo

Pfizer··NCT06086340·779 enrolled

Tics3 trials

Phase IV Multi-arm Study of CDK4/6 Pharmacokinetics in Healthy Volunteers With Known CYP3A4*22 Genotype

Withdrawn·UUniversity of Michigan Rogel Cancer Center·Phase 4·NCT05691400

Effect Of Modafinil And Pioglitazone On The Pharmacokinetics Of Palbociclib (PD-0332991)

Completed· Pfizer logo

Pfizer·Phase 1·NCT02222441·14 enrolled

Effect Of Itraconazole On The Pharmacokinetics Of Palbociclib

Completed· Pfizer logo

Pfizer·Phase 1·NCT02131298·12 enrolled

Liposarcoma2 trials

PD0332991 (Palbociclib) in Patients With Advanced or Metastatic Liposarcoma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT01209598·90 enrolled

Palbociclib and INCMGA00012 in People With Advanced Liposarcoma

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT04438824·42 enrolled

Tumor2 trials

PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection

Completed·UUNICANCER·Phase 3·NCT03079011·1,017 enrolled

Tumor Response Time of Palbociclib in Combination With AI in Real-world Chinese Patients

Unknown status·ZZhejiang Cancer Hospital·Phase 2·NCT04858997·150 enrolled

Esophageal Squamous Cell Carcinoma2 trials

Neoadjuvant Camrelizumab With Palbociclib for Resectable Esophageal Squamous Cell Carcinomas

Recruiting·WWest China Hospital·Phase 1·NCT06654297·6 enrolled

Neoadjuvant Camrelizumab With Palbociclib for Resectable Esophageal Squamous Cell Carcinoma

Not yet recruiting·WWest China Hospital·Phase 2·NCT07191977·41 enrolled

Cancer2 trials

TAS-116 Plus Palbociclib in Breast and Rb-null Cancer

Withdrawn·—·Phase 1·NCT05655598

OPTI - DOSE: Optimal Dosing of Oral Anticancer Drugs in Older Adults

Unknown status·UUniversity Medical Center Groningen·Phase 4·NCT05949424·30 enrolled

Hormone Receptor Positive2 trials

A Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery

Completed·GGBG Forschungs GmbH·Phase 3·NCT01864746·1,250 enrolled

Palbociclib Plus Letrozole in Hormone Receptor Positive Residual Disease After Neoadjuvant Chemotherapy

Completed·SSOLTI Breast Cancer Research Group·Phase 1·NCT04130152·22 enrolled

Advanced or Metastatic Solid Tumors2 trials

Talazoparib and Palbociclib, Axitinib, or Crizotinib for the Treatment of Advanced or Metastatic Solid Tumors, TalaCom Trial

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT04693468·111 enrolled

Study of PF-07248144 in Advanced or Metastatic Solid Tumors

Recruiting· Pfizer logo

Pfizer·Phase 1·NCT04606446·320 enrolled

Interaction2 trials

Drug Interaction Study To Investigate The Potential Effect Of Proton Pump Inhibitor On The Pharmacokinetics Of Palbociclib (PD-0332991)

Completed· Pfizer logo

Pfizer·Phase 1·NCT01918176·26 enrolled

A Study To Investigate The Drug-Drug Interaction Potential Of Rifampin OnThe Investigational Agent Palbociclib (PD-0332991)

Completed· Pfizer logo

Pfizer·Phase 1·NCT01953731·15 enrolled

Non-Small Cell Lung Cancer2 trials

Study of Palbociclib in Combination With Binimetinib for Patients With Advanced KRAS Mutant Non-Small Cell Lung Cancer

Completed·—·Phase 1·NCT03170206·34 enrolled

National Lung Matrix Trial: Multi-drug Phase II Trial in Non-Small Cell Lung Cancer

Active, not recruiting·UUniversity of Birmingham·Phase 2·NCT02664935·423 enrolled

Lung Cancer2 trials

Lung-MAP: Palbociclib as Second-Line Therapy in Treating Cell Cycle Gene Alteration Positive Patients With Recurrent Stage IV Squamous Cell Lung Cancer

Completed·SSWOG Cancer Research Network·Phase 2/3·NCT02785939·53 enrolled

Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer

Completed·SSWOG Cancer Research Network··NCT02154490·1,864 enrolled

Refractory Solid Tumors2 trials

Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors

Active, not recruiting· Pfizer logo

Pfizer·Phase 2·NCT03709680·128 enrolled

Study of Pazopanib Combined With Palbociclib for Refractory Solid Tumors With Co-amplified in the 11q13(FGF3/4/19/CCND1)

Recruiting·TTianjin Medical University Second Hospital·Phase 1/2·NCT06895733·65 enrolled

Head and Neck Squamous Cell Carcinoma2 trials

Los Tres Paso: Neoadjuvant Palbociclib Monotherapy, Concurrent Chemoradiation Therapy, Adjuvant Palbociclib Monotherapy in Patients With p16INK4a Negative, HPV-Unrelated Head and Neck Squamous Cell Carcinoma

Active, not recruiting·WWashington University School of Medicine·Phase 2·NCT03389477·26 enrolled

Avelumab, Cetuximab, and Palbociclib in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Active, not recruiting·KKathryn Gold·Phase 1·NCT03498378·24 enrolled

Colorectal Cancer1 trial

Binimetinib and Palbociclib or TAS-102 in Treating Patients With KRAS and NRAS Mutant Metastatic or Unresectable Colorectal Cancer

Completed·—·Phase 2·NCT03981614·102 enrolled

Precision Therapy1 trial

Precision Therapy for Solid Tumors: Synergistic CDK4/6 Inhibition and Anti-VEGF Targeting LncRNA

Recruiting·LLebanese University·Phase 1·NCT06307249·50 enrolled

Ovarian Cancer1 trial

Palbociclib Plus Letrozole Treatment After Progression to Second Line Chemotherapy for Women With ER/PR-positive Ovarian Cancer

Completed·LLatin American Cooperative Oncology Group·Phase 2·NCT03936270·43 enrolled

Hepatic Function1 trial

A Study To Describe The Effect Of Impaired Hepatic Function Of The Pharmacokinetics Of Palbociclib

Completed· Pfizer logo

Pfizer·Phase 1·NCT02334800·28 enrolled

Acute Lymphoblastic Leukemia1 trial

Treatment With Combination Chemotherapy for Relapsed or Refractory Acute Lymphoblastic Leukemia

Terminated·SSt. Jude Children's Research Hospital·Phase 1·NCT03515200·12 enrolled

Rare Tumor1 trial

PLATFORM Study of Precision Medicine for Rare Tumors

Recruiting·—·Phase 2·NCT04423185·770 enrolled

Phase IB1 trial

A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC

Recruiting·FForward Pharmaceuticals Co., Ltd.·Phase 1/2·NCT07002177·196 enrolled

Hepatocellular Carcinoma1 trial

Backline Treatment of Advanced Hepatocellular Carcinoma With Palbociclib

Recruiting·HHenan Cancer Hospital·N/A·NCT06478927·22 enrolled

Advanced Cancer1 trial

Histology-Independent Study of Palbociclib in Patients With Advanced Cancer

Withdrawn·—·Phase 2·NCT03123744

Absorption1 trial

Characterization Of The Effect Of Food On Palbociclib (PD-0332991) Absorption

Completed· Pfizer logo

Pfizer·Phase 1·NCT01904747·28 enrolled

Neoadjuvant Chemotherapy1 trial

Palbociclib + Letrozole Versus Epirubicin + Cyclophosphamide and Sequential Docetaxel as Neoadjuvant Chemotherapy

Not yet recruiting·SShengjing Hospital·Phase 4·NCT04137640·152 enrolled

Age1 trial

Study Of Three Different Stomach Acid Reducing Agents When Given With Palbociclib (PD-0332991) And Food

Completed· Pfizer logo

Pfizer·Phase 1·NCT02097329·27 enrolled

Experimental1 trial

A Pilot Study To Investigate The Effect Of Concurrent Antacid Administration On The Bioavailability Of Six Experimental Formulations Of Palbociclib

Completed· Pfizer logo

Pfizer·Phase 1·NCT02311946·60 enrolled

Patients With Solid Tumors1 trial

A Study of Telaglenastat (CB-839) in Combination With Palbociclib in Patients With Solid Tumors

Completed·CCalithera Biosciences, Inc·Phase 1/2·NCT03965845·53 enrolled

Central Nervous System Tumor1 trial

Palbociclib Isethionate in Treating Younger Patients With Recurrent, Progressive, or Refractory Central Nervous System Tumors

Terminated·PPediatric Brain Tumor Consortium·Phase 1·NCT02255461·35 enrolled

Fed1 trial

Relative Bioavailability Of Palbociclib (PD-0332991) Under Fed And Fasted Conditions

Completed· Pfizer logo

Pfizer·Phase 1·NCT02041273·36 enrolled

Immunotherapy1 trial

The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy

Unknown status·FFondazione per la Medicina Personalizzata·Phase 2·NCT04591431·400 enrolled

Patients With Advanced Solid Tumors1 trial

Adagrasib in Combination With Palbociclib in Patients With Advanced Solid Tumors (KRYSTAL-16)

Completed·MMirati Therapeutics Inc.·Phase 1·NCT05178888·11 enrolled

Melanoma1 trial

Efficacy of Palbociclib in Advanced Acral Melanoma With Cell Cycle Gene Aberrations

Unknown status·PPeking University Cancer Hospital & Institute·Phase 2·NCT03454919·60 enrolled

COVID-191 trial

Phase II Safety Single-arm Study of CDK4/6 Inhibition With Palbociclib in Hospitalized, Moderate COVID-19 Cases to Prevent Thromboinflammation

Withdrawn·Bbiotx.ai GmbH·Phase 2·NCT05371275

Hormone Receptor Positive Tumor1 trial

Neoadjuvant Response-guided Treatment of Slowly Proliferating Hormone Receptor Positive Tumors

Active, not recruiting·TThomas Hatschek·Phase 2·NCT02592083·10 enrolled

Ptosis1 trial

"Neo-Adjuvant Treatment With Palbociclib: Effect on Ki67 and Apoptosis Before, During and After Treatment "

Completed·FFondazione Michelangelo·Phase 2·NCT02530424·102 enrolled

Advanced Soft-tissue Sarcoma1 trial

Molecular Profiling of Advanced Soft-tissue Sarcomas

Active, not recruiting·IInstitut National de la Santé Et de la Recherche Médicale, France·Phase 3·NCT03784014·603 enrolled

Advanced Stage Cancer1 trial

TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer

Recruiting·AAmerican Society of Clinical Oncology·Phase 2·NCT02693535·4,200 enrolled

Adjuvant1 trial

PALbociclib CoLlaborative Adjuvant Study

Active, not recruiting·AAlliance Foundation Trials, LLC.·Phase 3·NCT02513394·5,796 enrolled

Gynecologic Cancer1 trial

Abexinostat, Palbociclib, and Fulvestrant for the Treatment of Breast or Gynecologic Cancer

Withdrawn·PPamela Munster·Phase 1·NCT04498520

Dedifferentiated Liposarcoma1 trial

Testing the Addition of Cemiplimab to Palbociclib for the Treatment of Advanced Dedifferentiated Liposarcoma

Active, not recruiting·AAlliance for Clinical Trials in Oncology·Phase 2·NCT05694871·77 enrolled

Squamous Cell Carcinoma1 trial

Palbociclib With Cetuximab and IMRT for Locally Advanced Squamous Cell Carcinoma

Active, not recruiting·MMahidol University·Phase 1/2·NCT03024489·27 enrolled

Ewing sarcoma1 trial

Palbociclib + Ganitumab In Ewing Sarcoma

Terminated·—·Phase 2·NCT04129151·10 enrolled

Solid Tumors1 trial

PALBOCICLIB + PD-0325901 for NSCLC & Solid Tumors

Completed·—·Phase 1·NCT02022982·60 enrolled

Renal Impairment1 trial

Study Of Palbociclib (PD-0332991) In Renal Impairment

Completed· Pfizer logo

Pfizer·Phase 1·NCT02085538·31 enrolled

Abemaciclib1 trial

A Randomized Study Comparing the Immune Modulation Effect of Ribociclib, Palbociclib, and Abemaciclib in ER+/HER2- EBC

Recruiting·NNational Taiwan University Hospital·Phase 2·NCT05766410·60 enrolled

Efficacy and Safety1 trial

A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors

Active, not recruiting· Roche logo

Roche·Phase 2·NCT04931342·176 enrolled

Renal Cell Carcinoma1 trial

A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma

Recruiting·SStephanie Berg·Phase 2·NCT07123090·25 enrolled

HER2 Positive1 trial

Anastrozole, Palbociclib, Trastuzumab and Pertuzumab in HR-positive, HER2-positive Metastatic Breast

Active, not recruiting·IIcahn School of Medicine at Mount Sinai·Phase 1/2·NCT03304080·44 enrolled

Metastatic Melanoma1 trial

Encorafenib, Binimetinib and Palbociclib in BRAF-mutant Metastatic Melanoma CELEBRATE

Unknown status·PPeter MacCallum Cancer Centre, Australia·Phase 1/2·NCT04720768·78 enrolled

Observational Study1 trial

Analysis of Therapy Sequence in Women With HR+, HER2 - mBC in Moscow: A Multicenter Retrospective Observational Study.

Unknown status·—··NCT04852081·1,000 enrolled

Leukemia1 trial

Palbociclib and Sorafenib, Decitabine, or Dexamethasone in Treating Patients With Recurrent or Refractory Leukemia

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT03132454·32 enrolled

CDK4/6 Inhibitor1 trial

Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT04964934·315 enrolled

EGFR Mutation1 trial

Study For Patients With NSCLC EGFR Mutations (Del 19 or L858R +/- T790M)

Terminated· Pfizer logo

Pfizer·Phase 1/2·NCT02349633·65 enrolled

Resistance1 trial

Molecular Mechanisms of Resistance and Sensitivity to Palbociclib Re-challenge in ER+ mBC

Completed·MMedSIR·Phase 2·NCT03184090·33 enrolled

Pembrolizumab1 trial

Palbociclib and Pembrolizumab in Sarcoma

Recruiting·JJohn Rieth·Phase 1·NCT06113809·8 enrolled

Prostate Cancer1 trial

Palbociclib in Patients With Metastatic Castration-Resistant Prostate Cancer

Active, not recruiting·CCanadian Cancer Trials Group·Phase 2·NCT02905318·19 enrolled

Other Solid Tumors1 trial

Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors

Recruiting·UUNC Lineberger Comprehensive Cancer Center·Phase 1·NCT03454035·45 enrolled

Nab-paclitaxel1 trial

Dose-Escalation Study Of Palbociclib + Nab-Paclitaxel In mPDAC

Completed· Pfizer logo

Pfizer·Phase 1·NCT02501902·76 enrolled

Menopausal Women1 trial

A Study of Palbociclib With Exemestane Plus GnRH Versus Capecitabine in Premenopausal Women With HR+ MBC

Unknown status·SSamsung Medical Center·Phase 2·NCT02592746·182 enrolled

Oligodendroglioma1 trial

Safety and Efficacy of PD0332991 (Palbociclib), a Cyclin-dependent Kinase 4 and 6 Inhibitor, in Patients With Oligodendroglioma or Recurrent Oligoastrocytoma Anaplastic With the Activity of the Protein RB Preserved

Completed·GGrupo Español de Investigación en Neurooncología·Phase 2·NCT02530320·34 enrolled

Mantle Cell Lymphoma1 trial

Ibrutinib and Palbociclib in Treating Patients With Previously Treated Mantle Cell Lymphoma

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT02159755·28 enrolled

Preoperative1 trial

Preoperative Palbociclib in Patients With DCIS of the Breast That Are Candidates for Surgery

Terminated·GGeorgetown University·Phase 2·NCT03535506·17 enrolled

Glioblastoma1 trial

Pilot Trial for Treatment of Recurrent Glioblastoma

Recruiting·AAHS Cancer Control Alberta·Phase 1·NCT05432518·10 enrolled

Advanced Sarcoma1 trial

Trial of Palbociclib in Second Line of Advanced Sarcomas With CDK4 Overexpression.

Unknown status·GGrupo Espanol de Investigacion en Sarcomas·Phase 2·NCT03242382·40 enrolled

Pancreatic Neuroendocrine Tumor1 trial

A Trial to Assess the Activity and Safety of Palbociclib in Patients With Well and Moderately Differentiated Metastatic Pancreatic Neuroendocrine Tumors (pNET)

Completed·GGrupo Espanol de Tumores Neuroendocrinos·Phase 2·NCT02806648·21 enrolled

Biomarker1 trial

Biomarker-based Study in R/M SCCHN

Unknown status·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT03088059·340 enrolled

PET1 trial

Palbociclib and FES PET

Completed·UUniversity Medical Center Groningen·Phase 2·NCT02806050·30 enrolled

Metastatic Colorectal Cancer1 trial

Palbociclib and Cetuximab in Metastatic Colorectal Cancer

Completed·UUNC Lineberger Comprehensive Cancer Center·Phase 2·NCT03446157·24 enrolled

Metastatic Urothelial Cancer1 trial

Phase II Trial of Palbociclib in Patients With Metastatic Urothelial Cancer After Failure of First-Line Chemotherapy

Terminated·UUNC Lineberger Comprehensive Cancer Center·Phase 2·NCT02334527·12 enrolled

B-cell acute lymphoblastic leukemia1 trial

Palbociclib and Dexamethasone in Treating Participants With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia

Completed·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 1·NCT03472573·7 enrolled

Multiple Myeloma1 trial

Palbociclib in Combination With Lenalidomide and Dexamethasone for Multiple Myeloma

Terminated·WWeill Medical College of Cornell University·Phase 1·NCT02030483·9 enrolled

Pilot Study1 trial

Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study

Terminated·PPeter MacCallum Cancer Centre, Australia·N/A·NCT04801966·3 enrolled

Central Nervous System1 trial

Palbociclib and Pembrolizumab In Central Nervous System Metastases

Recruiting·MMassachusetts General Hospital·Phase 2·NCT02896335·45 enrolled

Acute Leukemia1 trial

Study of Palbociclib in MLL-rearranged Acute Leukemias

Unknown status·UUniversity of Ulm·Phase 1/2·NCT02310243·50 enrolled

Head and Neck Cancer1 trial

Safety And Efficacy Study Of Palbociclib Plus Cetuximab Versus Cetuximab To Treat Head And Neck Cancer

Completed· Pfizer logo

Pfizer·Phase 2·NCT02499120·125 enrolled

Gastroesophageal Junction1 trial

Palbociclib Combined With Afatinib for Advanced Squamous Carcinoma of Esophagus or Gastroesophageal Junction

Recruiting·AAiping Zhou·Phase 2·NCT05865132·30 enrolled

Unspecified6 trials

Bioequivalence Study of Palbociclib 125 mg Capsules of Iclos vs. Ibrance (Palbociclib) Capsules 125 mg

Completed·MMegalabs·Phase 4·NCT06331715·24 enrolled

Relative Bioavailability For Palbociclib Formulations

Completed· Pfizer logo

Pfizer·Phase 1·NCT02083640·30 enrolled

A Study To Establish The Equivalence Of 2 Palbociclib (PD-0332991) Formulations To The Intended Final Market Product

Completed· Pfizer logo

Pfizer·Phase 1·NCT01906125·73 enrolled

Show 3 more trials

PIPA: Combination of PI3 Kinase Inhibitors and PAlbociclib

Completed·RRoyal Marsden NHS Foundation Trust·Phase 1·NCT02389842·79 enrolled

NCT Neuro Master Match - N²M² (NOA-20)

Completed·UUniversity Hospital Heidelberg·Phase 1/2·NCT03158389·228 enrolled

Palbociclib With Everolimus + Exemestane In BC

Completed·—·Phase 1/2·NCT02871791·41 enrolled

Regulatory

FDA Approval Timeline[5]

Feb 3, 2015

IBRANCE

NDA NDA207103

Nov 1, 2019

IBRANCE

NDA NDA212436

Sources

References

[1]
ClinicalTrials.gov — 301 trial records for Palbociclib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Ibrance drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Palbociclib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Palbociclib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA212436). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Ibrance. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Cyclin-Dependent Kinase 4/cyclin D1 Inhibitor; Cdk6/cyclin D1 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Pfizer

Patent Landscape[6]

Patent Cliff

Mar 5, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

RE47739Mar 5, 2027

RE47739*PEDSep 5, 2027

10723730Feb 8, 2034

10723730*PEDAug 8, 2034

11065250Aug 19, 2036

1 more patents

11065250*PEDFeb 19, 2037