Torisel

(Temsirolimus)

ApprovedSmall molecule

Temsirolimus is used to treat advanced kidney cancer and a type of blood cancer called mantle cell lymphoma. It works by slowing down the growth of cancer cells in the body.[2] Torisel is currently approved and in use across 32 indications[4].[1]

Torisel is one of 650 small molecule programs targeting Non-Hodgkins Lymphoma. It is currently in Approved.

Indications

174

Total Trials

Active Trials

649

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Non-Hodgkins LymphomaApproved

Prostate AdenocarcinomaApproved

Prostate NeoplasmActive, not recruiting

IschemiaApproved

TicsActive, not recruiting

Central Nervous System NeoplasmApproved

Cutaneous MelanomaApproved

AdenocarcinomaApproved

Hodgkins LymphomaApproved

Adult GlioblastomaApproved

Non-Hodgkins LymphomaApproved

Approved

Prostate AdenocarcinomaApproved

Approved

Prostate NeoplasmPreclinical

Active, not recruiting

IschemiaApproved

Approved

TicsPhase 1

Active, not recruiting

Central Nervous System NeoplasmApproved

Approved

Cutaneous MelanomaApproved

Approved

AdenocarcinomaApproved

Approved

Hodgkins LymphomaApproved

Approved

Adult GlioblastomaApproved

Approved

Showing 10 of 32 indications

Competition

Competitive Landscape

176 competitors in Rheumatoid Arthritis

#DrugCompanyPhaseTrials

Torisel

PPrism Pharmaceuticals

Actos

2 3

Celexa

AbbVie

Preclinical

1 4

Plaquenil

Cataflam

Voltaren

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

2 8

Vancocin

HHikma Pharmaceuticals LLC

Preclinical

1 9

Nsaids

Roche

Preclinical

1 10

Decadron

QQuince Therapeutics S.p.A.

Preclinical

—

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

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Advanced Rare Tumours

NCT01396408

Q1 2027

Phase 2Recruiting

Trial

NCT03297606

Phase 2Active, not recruiting

Endometrial Adenocarcinoma

NCT00977574

Phase 1Active, not recruiting

Adult Solid Neoplasm

NCT01375829

Q4 2027

Phase 1Active, not recruiting

Advanced Malignant Solid Neoplasm

NCT02389309

Q2 2028

Phase 1Active, not recruiting

Advanced Cancer

NCT01187199

Clinical

Trials by Indication[1]

Lymphoma12 trials

Bendamustine and Temsirolimus in Patients With Relapsed or Refractory Mantle Cell Non-Hodgkin's Lymphoma (NHL)

Withdrawn·—·Phase 1/2·NCT01170052·20 enrolled

Vinblastine and Temsirolimus in Pediatrics With Recurrent or Refractory Lymphoma or Solid Tumours Including CNS Tumours

Completed·CCanadian Cancer Trials Group·Phase 1·NCT02343718·7 enrolled

Temsirolimus and Brentuximab Vedotin in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT01902160·3 enrolled

Show 9 more trials

Temsirolimus in Treating Patients With Metastatic Solid Tumor or Lymphoma That Cannot Be Removed By Surgery Who Have Different Levels of Liver Function

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00275093·130 enrolled

Lenalidomide and Temsirolimus in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma or Non-Hodgkin Lymphoma

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT01076543·110 enrolled

CCI-779 and Rituximab in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00109967·71 enrolled

Metformin and Temsirolimus in Treating Patients With Metastatic or Unresectable Solid Tumor or Lymphoma

Completed·LLondon Health Sciences Centre·Phase 1·NCT00659568·28 enrolled

Temsirolimus for Relapsed/Refractory Hodgkin's Lymphoma

Terminated·LLoyola University·Phase 2·NCT00838955·14 enrolled

Study of Inotuzumab Ozogamicin + Temsirolimus in Patients With Relapsed or Refractory CD22+ B-cell NHLymphoma

Completed·CCristiana Sessa·Phase 1·NCT01535989·25 enrolled

CCI-779 in Treating Patients With Mantle Cell Non-Hodgkin's Lymphoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00033267·27 enrolled

Temsirolimus in Recurrent Primary Central Nervous System (CNS) Lymphoma

Unknown status·—·Phase 2·NCT00942747·37 enrolled

Study of Velcade and Temsirolimus for Relapsed or Refractory Non-Hodgkin Lymphoma

Completed·UUniversity of Wisconsin, Madison·Phase 2·NCT01281917·40 enrolled

Renal Cell Carcinoma7 trials

Efficacy and Safety of Bevacizumab/Temsirolimus Combination to Treat Advanced Renal Cell Carcinoma

Terminated·HHellenic Cooperative Oncology Group·Phase 2·NCT01264341·39 enrolled

Neo-adjuvant Temsirolimus in Patients With Advanced Renal Cell Carcinoma

Completed·SSt. Joseph's Healthcare Hamilton·N/A·NCT01404104·11 enrolled

Combination of Temsirolimus and Bevacizumab in Patient With Metastatic Renal Cell Carcinoma

Completed·CCentre Leon Berard·Phase 2·NCT00619268·160 enrolled

Show 4 more trials

Study Evaluating The Safety, Efficacy & Pharmacokinetics Of Temsirolimus(CCI-779) In Subjects With Advanced Renal Cell Carcinoma

Completed· Pfizer logo

Pfizer·Phase 2·NCT00494091·82 enrolled

Pazopanib Versus Temsirolimus in Poor-Risk Clear-Cell Renal Cell Carcinoma (RCC)

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT01392183·69 enrolled

Study Comparing Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects

Completed· Pfizer logo

Pfizer·Phase 3·NCT00631371·791 enrolled

Avastin and Temsirolimus Following Tyrosine Kinase Inhibitor Failure in Patients With Advanced Renal Cell Carcinoma

Completed·—·Phase 2·NCT00782275·41 enrolled

Prostate Cancer6 trials

CESAR Study in Prostate Cancer With Temsirolimus Added to Standard Docetaxel Therapy (CEPTAS)

Completed·CCentral European Society for Anticancer Drug Research·Phase 1/2·NCT01206036·19 enrolled

Hormone Therapy and Temsirolimus in Treating Patients With Relapsed Prostate Cancer

Terminated·NNational Cancer Institute (NCI)·Phase 1·NCT00512668·24 enrolled

Temsirolimus to Reverse Androgen Insensitivity for Castration-resistant Prostate Cancer

Terminated·SSandy Srinivas·Phase 1/2·NCT01020305·5 enrolled

Show 3 more trials

An Open Label Exploratory Study in Newly Diagnosed Prostate Cancer Patients

Completed· Pfizer logo

Pfizer·N/A·NCT00235794·50 enrolled

CCI-779 in Treating Patients With Prostate Cancer

Completed·JJonsson Comprehensive Cancer Center·Phase 2·NCT00012142

Neoadjuvant CCI-779 Followed By Radical Prostatectomy in Treating Patients With Newly Diagnosed Prostate Cancer Who Have a High Risk of Relapse

Completed·JJonsson Comprehensive Cancer Center·Phase 2·NCT00071968·15 enrolled

Mantle Cell Lymphoma5 trials

Comparison Of 2 Doses Of Temsirolimus (Torisel) In Patients With Mantle Cell Lymphoma

Completed· Pfizer logo

Pfizer·Phase 4·NCT01180049·101 enrolled

Registry For Temsirolimus, Sunitinib, And Axitinib Treated Patients With Metastatic Renal Cell Carcinoma (mRCC), Mantle Cell Lymphoma (MCL), And Gastro-Intestinal Stroma Tumor (GIST) [STAR-TOR]

Completed· Pfizer logo

Pfizer··NCT00700258·1,520 enrolled

Study Evaluating Temsirolimus (CCI-779) In Mantle Cell Lymphoma (MCL)

Completed· Pfizer logo

Pfizer·Phase 3·NCT00117598·169 enrolled

Show 2 more trials

Study of Ibrutinib (a Bruton's Tyrosine Kinase Inhibitor), Versus Temsirolimus in Patients With Relapsed or Refractory Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01646021·280 enrolled

Rituximab, Cladribine, and Temsirolimus in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma

Completed·AAlliance for Clinical Trials in Oncology·Phase 1·NCT00787969·74 enrolled

Advanced Cancer5 trials

Phosphatidylinositol 3 Kinase and Mammalian Target of Rapamycin (PI3K-mTOR) in Advanced Cancer Patients

Terminated·MM.D. Anderson Cancer Center·Phase 1/2·NCT00877773·44 enrolled

Study of Nivolumab Plus Chemotherapy in Patients With Advanced Cancer (NivoPlus)

Terminated·WWestern Regional Medical Center·Phase 1/2·NCT02423954·33 enrolled

Vemurafenib in Combination With Everolimus or Temsirolimus With Advanced Cancer

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT01596140·27 enrolled

Show 2 more trials

Phase I Trial of Bevacizumab and Temsirolimus in Combination With 1) Carboplatin, 2) Paclitaxel, 3) Sorafenib for the Treatment of Advanced Cancer

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT01187199·278 enrolled

A Phase I Trial of Sirolimus or Everolimus or Temsirolimus (mTOR Inhibitor) and Vorinostat (Histone Deacetylase Inhibitor) in Patients With Advanced Cancer

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT01087554·249 enrolled

80 more indications

Patients With Advanced Solid Tumors5 trials

S0718 Pazopanib and Temsirolimus in Treating Patients With Advanced Solid Tumors

Withdrawn·SSWOG Cancer Research Network·Phase 1·NCT00788580

Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 and Temsirolimus in Treating Patients With Advanced Solid Tumors

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT01198184·18 enrolled

Temsirolimus, Carboplatin, and Paclitaxel in Treating Patients With Advanced Solid Tumors

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00408655·38 enrolled

Show 2 more trials

CCI-779 and EKB-569 in Treating Patients With Advanced Solid Tumors

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00098501·42 enrolled

CCI-779 in Treating Patients With Advanced Solid Tumors

Completed·TThe University of Texas Health Science Center at San Antonio·Phase 1·NCT00003712·15 enrolled

Metastatic Prostate Cancer4 trials

Impact of Temsirolimus Therapy on Circulating Tumor Cell Biology In Men With Castration Resistant Metastatic Prostate Cancer

Terminated·—·Phase 2·NCT00887640·11 enrolled

Temsirolimus and Bevacizumab in Hormone-Resistant Metastatic Prostate Cancer That Did Not Respond to Chemotherapy

Completed·—·Phase 1/2·NCT01083368·22 enrolled

Cixutumumab and Temsirolimus in Treating Patients With Metastatic Prostate Cancer

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT01026623·16 enrolled

Show 1 more trial

Temsirolimus and Vorinostat in Treating Patients With Metastatic Prostate Cancer

Terminated·RRoswell Park Cancer Institute·Phase 1·NCT01174199·13 enrolled

Patients With Solid Tumors4 trials

Metronomic Therapy for Pediatric Patients With Solid Tumors at High Risk of Recurrence

Recruiting·—·Phase 1·NCT02446431·20 enrolled

Cixutumumab and Temsirolimus in Treating Younger Patients With Solid Tumors That Have Recurred or Not Responded to Treatment

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00880282·39 enrolled

Tivantinib and Temsirolimus in Treating Patients With Solid Tumors That is Metastatic or Cannot be Removed by Surgery

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT01625156·11 enrolled

Show 1 more trial

Trebananib And Temsirolimus in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT01548482·21 enrolled

Non-Small Cell Lung Cancer4 trials

Temsirolimus and Radiation for Non-Small Cell Lung Cancer

Completed·WWashington University School of Medicine·Phase 1·NCT00796796·10 enrolled

Temsirolimus and Pemetrexed for Recurrent or Refractory Non-Small Cell Lung Cancer

Terminated·WWashington University School of Medicine·Phase 1/2·NCT00921310·12 enrolled

CCI-779 in Treating Patients With Stage IIIB (With Pleural Effusion) or Stage IV Non-Small Cell Lung Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00079235·50 enrolled

Show 1 more trial

Neratinib With and Without Temsirolimus for Patients With HER2 Activating Mutations in Non-Small Cell Lung Cancer

Completed·PPuma Biotechnology, Inc.·Phase 2·NCT01827267·62 enrolled

Glioblastoma Multiforme4 trials

A Study of Temsirolimus and Bevacizumab in Recurrent Glioblastoma Multiforme

Completed·RRigshospitalet, Denmark·Phase 2·NCT00800917·12 enrolled

CCI-779 in Treating Patients With Recurrent Glioblastoma Multiforme

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00016328·33 enrolled

Sorafenib Combined With Erlotinib, Tipifarnib, or Temsirolimus in Treating Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT00335764·92 enrolled

Show 1 more trial

Temsirolimus, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00316849·56 enrolled

Metastatic Solid Tumors4 trials

Hydroxychloroquine and Temsirolimus in Treating Patients With Metastatic Solid Tumors That Have Not Responded to Treatment

Completed·—·Phase 1·NCT00909831·40 enrolled

Temsirolimus and Vinorelbine Ditartrate in Treating Patients With Unresectable or Metastatic Solid Tumors

Completed·UUniversity of Southern California·Phase 1·NCT01155258·19 enrolled

Temsirolimus and Bryostatin 1 in Treating Patients With Unresectable or Metastatic Solid Tumors

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00112476·24 enrolled

Show 1 more trial

Sorafenib and Temsirolimus in Treating Patients With Unresectable or Metastatic Solid Tumors

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00255658·40 enrolled

Solid Tumors4 trials

Study of Temsirolimus, Erlotinib and Cisplatin in Solid Tumors

Completed·—·Phase 1·NCT00998036·9 enrolled

Erlotinib and Temsirolimus for Solid Tumors

Completed·WWashington University School of Medicine·Phase 1·NCT00770263·46 enrolled

Study Evaluating Neratinib In Combination With Temsirolimus In Subjects With Solid Tumors

Completed·PPuma Biotechnology, Inc.·Phase 1·NCT00838539·63 enrolled

Show 1 more trial

Study of Axitinib and Temsirolimus in Solid Tumors

Completed·EEmory University·Phase 1·NCT01529138·13 enrolled

Melanoma4 trials

Sorafenib With Either Temsirolimus or Tipifarnib in Treating Patients With Stage IV Malignant Melanoma That Cannot Be Removed By Surgery

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00281957·109 enrolled

Sorafenib and Temsirolimus in Treating Patients With Metastatic, Recurrent, or Unresectable Melanoma

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00349206·69 enrolled

Sorafenib and Temsirolimus in Treating Patients With Metastatic, Recurrent, or Unresectable Melanoma

Withdrawn·NNational Cancer Institute (NCI)·Phase 2·NCT01851408

Show 1 more trial

Temsirolimus and Bevacizumab in Treating Patients With Stage III or Stage IV Malignant Melanoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00397982·17 enrolled

Malignant Glioma4 trials

Perifosine and Torisel (Temsirolimus) for Recurrent/Progressive Malignant Gliomas

Completed·—·Phase 1·NCT02238496·10 enrolled

Erlotinib and Temsirolimus in Treating Patients With Recurrent Malignant Glioma

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT00112736·69 enrolled

Temsirolimus and Perifosine in Treating Patients With Recurrent or Progressive Malignant Glioma

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT01051557·36 enrolled

Show 1 more trial

CCI-779 in Treating Patients With Malignant Glioma

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1/2·NCT00022724·49 enrolled

Squamous Cell Carcinoma3 trials

Temsirolimus (Torisel®) and Erlotinib (Tarceva®) in Platinum-Refractory/Ineligible, Advanced, Squamous Cell Carcinoma

Terminated·NNew Mexico Cancer Research Alliance·Phase 2·NCT01009203·13 enrolled

Combination of Cisplatin, Cetuximab and Temsirolimus in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Terminated·UUniversity of Tennessee Cancer Institute·Phase 1/2·NCT01015664·11 enrolled

Study Evaluating Temsirolimus in Advanced Stage Squamous Cell Carcinoma of the Head & Neck

Completed· Pfizer logo

Pfizer··NCT00195299·20 enrolled

Endometrial Cancer3 trials

Bevacizumab and Temsirolimus in Treating Patients With Recurrent or Persistent Endometrial Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00723255·53 enrolled

Temsirolimus in Treating Patients With Metastatic or Locally Advanced Recurrent Endometrial Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00072176·62 enrolled

Temsirolimus With or Without Megestrol Acetate and Tamoxifen Citrate in Treating Patients With Advanced, Persistent, or Recurrent Endometrial Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00729586·73 enrolled

Bevacizumab3 trials

Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01010126·252 enrolled

Bevacizumab and Temsirolimus Alone or in Combination With Valproic Acid or Cetuximab in Treating Patients With Advanced or Metastatic Malignancy or Other Benign Disease

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT01552434·155 enrolled

Doxil, Bevacizumab and Temsirolimus Trial

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT00761644·200 enrolled

Multiple Myeloma3 trials

Lenalidomide and Temsirolimus in Treating Patients With Previously Treated Multiple Myeloma

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00398515·25 enrolled

Temsirolimus and Dexamethasone in Treating Patients With Recurrent or Refractory Multiple Myeloma

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00693433·15 enrolled

Temsirolimus in Treating Patients With Relapsed or Refractory Multiple Myeloma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00079456·25 enrolled

Acute Lymphoblastic Leukemia3 trials

CCI-779 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes, or Chronic Myelogenous Leukemia in Blastic Phase

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00084916·74 enrolled

Temsirolimus, Dexamethasone, Mitoxantrone Hydrochloride, Vincristine Sulfate, and Pegaspargase in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT01403415·13 enrolled

A Trial of Temsirolimus With Etoposide and Cyclophosphamide in Children With Relapsed Acute Lymphoblastic Leukemia and Non-Hodgkins Lymphoma

Completed·TTherapeutic Advances in Childhood Leukemia Consortium·Phase 1·NCT01614197·16 enrolled

Breast Cancer3 trials

Temsirolimus in Treating Patients With Locally Advanced or Metastatic Breast Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00376688·31 enrolled

Cixutumumab and Temsirolimus in Treating Patients With Locally Recurrent or Metastatic Breast Cancer

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT00699491·48 enrolled

Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast Cancer

Completed·PPuma Biotechnology, Inc.·Phase 1/2·NCT01111825·99 enrolled

Soft Tissue Sarcoma3 trials

Temsirolimus and Valproic Acid in Treating Young Patients With Relapsed Neuroblastoma, Bone Sarcoma, or Soft Tissue Sarcoma

Terminated·UUNC Lineberger Comprehensive Cancer Center·Phase 1·NCT01204450·7 enrolled

Selumetinib With or Without Temsirolimus in Treating Patients With Metastatic, Recurrent, or Locally Advanced Soft Tissue Sarcoma That Cannot Be Removed By Surgery

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01206140·70 enrolled

Temsirolimus and Cixutumumab in Treating Patients With Locally Advanced, Metastatic, or Recurrent Soft Tissue Sarcoma or Bone Sarcoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01016015·178 enrolled

Solid Malignancies2 trials

Phase I Study of Docetaxel and Temsirolimus in Resistant Solid Malignancies

Completed·WWashington University School of Medicine·Phase 1·NCT00703625·26 enrolled

Phase I Study of DOXIL and Temsirolimus in Resistant Solid Malignancies

Completed·WWashington University School of Medicine·Phase 1·NCT00703170·28 enrolled

Glioblastoma2 trials

Sorafenib Tosylate and Temsirolimus in Treating Patients With Recurrent Glioblastoma

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT00329719·115 enrolled

Radiation Therapy and Temsirolimus or Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma

Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT01019434·111 enrolled

Pancreatic Cancer2 trials

Temsirolimus in Combination With Gemcitabine in Previously Untreated Metastatic Pancreatic Cancer

Terminated·MMassachusetts General Hospital·Phase 1·NCT00593008·5 enrolled

CCI-779 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00075647·40 enrolled

Chronic Lymphocytic Leukemia2 trials

CCI-779 in Treating Patients With Recurrent or Refractory B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00290472·89 enrolled

CCI-779 in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT00086840·60 enrolled

Outcome2 trials

Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee

Recruiting·MMercator MedSystems, Inc.·Phase 3·NCT04433572·250 enrolled

Temsirolimus Adventitial Delivery to Improve Angiographic Outcomes Below the Knee (TANGO)

Unknown status·MMercator MedSystems, Inc.·Phase 2·NCT02908035·100 enrolled

Lenalidomide2 trials

Lenalidomide in Combination With Bevacizumab, Sorafenib, Temsirolimus, or 5-Fluorouracil, Leucovorin, Oxaliplatin (FOLFOX)

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT01183663·180 enrolled

Effect of P-glycoprotein Inhibition on Lenalidomide Pharmacokinetics in Healthy Males

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT01712828·31 enrolled

Brain Tumors2 trials

A Feasibility, Dose-Escalation Study Using Intracerebral Microdialysis to Assess the Neuropharmacodynamics of Temsirolimus in Patients With Primary or Metastatic Brain Tumors

Completed·—·Phase 1·NCT00784914·12 enrolled

Assessment of Systemically Administered Torisel Delivery to Brain Tumors by Intratumoral Microdialysis

Withdrawn·EEmory University·Phase 1·NCT00949026

Neuroblastoma2 trials

Neuroblastoma Protocol 2008: Therapy for Children With Advanced Stage High Risk Neuroblastoma

Terminated·SSt. Jude Children's Research Hospital·Phase 2·NCT00808899·4 enrolled

Irinotecan Hydrochloride and Temozolomide With Temsirolimus or Dinutuximab in Treating Younger Patients With Refractory or Relapsed Neuroblastoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01767194·73 enrolled

Ovarian Cancer2 trials

Study of the mTOR Inhibitor Temsirolimus (CCI-779) to Treat Ovarian Cancer With CA125 Only Relapse

Terminated·HHellenic Cooperative Oncology Group·Phase 2·NCT00926107·9 enrolled

Temsirolimus, Carboplatin, and Paclitaxel as First-Line Therapy in Treating Patients With Newly Diagnosed Stage III-IV Clear Cell Ovarian Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01196429·90 enrolled

Endometrial Carcinoma2 trials

Efficacy,Tolerability,Safety of Temsirolimus in Women With Platinum-refractory Ovarian Carcinoma or Advanced Endometrial Carcinoma

Completed·AAGO Study Group·Phase 2·NCT01460979·47 enrolled

POEM STUDY: A Phase IIa Trial in Endometrial Carcinoma With Temsirolimus

Completed·MMedSIR·Phase 2·NCT02093598·10 enrolled

Drug2 trials

Temsirolimus (Torisel) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

Completed· Pfizer logo

Pfizer··NCT01210482·1,050 enrolled

A Post Marketing Surveillance As Required By Philippine Food And Drug Administration

Withdrawn· Pfizer logo

Pfizer··NCT01781442

Trial2 trials

Combination Trial of Pimasertib (MSC1936369B) With Temsirolimus

Terminated· EMD Serono logo

EMD Serono·Phase 1·NCT01378377·33 enrolled

Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR)

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

Renal Cell Cancer2 trials

Sunitinib Plus Temsirolimus in Patients With Renal Cell Cancer (RCC)

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT01122615·23 enrolled

Personalized Targeted Inhibitors Treatment in Renal Cell Cancer

Terminated·TThe University of Texas Health Science Center, Houston·Phase 2·NCT02560012·4 enrolled

Kidney Cancer2 trials

Chemotherapy and Biological Therapy in Treating Patients With Locally Advanced or Metastatic Kidney Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT00045370

Bevacizumab, Sorafenib Tosylate, and Temsirolimus in Treating Patients With Metastatic Kidney Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00378703·361 enrolled

Second-line Therapy2 trials

Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced RCC Who Have Failed First-Line Sunitinib

Completed· Pfizer logo

Pfizer·Phase 3·NCT00474786·512 enrolled

Temsirolimus as Second-line Therapy in HCC

Unknown status·UUniversity of Tennessee Cancer Institute·Phase 2·NCT01567930·25 enrolled

Rhabdomyosarcoma2 trials

Vinorelbine Tartrate and Cyclophosphamide in Combination With Bevacizumab or Temsirolimus in Treating Patients With Recurrent or Refractory Rhabdomyosarcoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01222715·87 enrolled

A Randomized Phase 3 Study of Vincristine, Dactinomycin, Cyclophosphamide (VAC) Alternating With Vincristine and Irinotecan (VI) Versus VAC/VI Plus Temsirolimus (TORI, Torisel, NSC# 683864) in Patients With Intermediate Risk (IR) Rhabdomyosarcoma (RMS)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT02567435·325 enrolled

Small Cell Lung Cancer1 trial

CCI-779 in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00028028·80 enrolled

Metastatic Colorectal Cancer1 trial

Temsirolimus and Irinotecan for Treatment Resistant Patients With Metastatic Colorectal Cancer and KRAS Mutations

Completed·VVejle Hospital·Phase 2·NCT00827684·50 enrolled

Leukemia1 trial

Study With Temsirolimus Added to Standard Chemotherapy for Patients Over 60 Years With Acute Myeloblastic Leukemia

Completed·GGoethe University·Phase 2·NCT01611116·33 enrolled

Unresectable1 trial

Temsirolimus/AZD 6244 for Treatment-naive With BRAF Mutant Unresectable Stage IV

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT01166126·4 enrolled

Advanced Malignancy1 trial

Bevacizumab and Temsirolimus in Patients With Advanced Malignancy

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT00610493·193 enrolled

Advanced Head and Neck Cancer1 trial

Torisel in Addition to Standard Chemotherapy With Radiation for Advanced Head and Neck Cancer

Withdrawn·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·N/A·NCT01326468

Refractory Solid Tumors1 trial

Temsirolimus, Irinotecan Hydrochloride, and Temozolomide in Treating Younger Patients With Relapsed or Refractory Solid Tumors

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT01141244·72 enrolled

Recurrent or Refractory Solid Tumors1 trial

A Phase I Study of IMC-A12 in Combination With Temsirolimus in Pediatric Patients With Recurrent or Refractory Solid Tumors

Withdrawn·NNational Cancer Institute (NCI)·Phase 1·NCT01182883

Dexamethasone1 trial

Temsirolimus Alone or Paired With Dexamethasone Delivered to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization

Terminated·MMercator MedSystems, Inc.·Phase 2·NCT03942601·10 enrolled

Liver Cancer1 trial

Temsirolimus in Treating Patients With Advanced Liver Cancer and Cirrhosis

Terminated·FFederation Francophone de Cancerologie Digestive·Phase 2·NCT01079767·6 enrolled

First Line Therapy1 trial

Gemcitabine Hydrochloride, Cisplatin, and Temsirolimus as First-Line Therapy in Treating Patients With Locally Advanced and/or Metastatic Transitional Cell Cancer of the Urothelium

Completed·—·Phase 1/2·NCT01090466·15 enrolled

Chronic Myelogenous Leukemia1 trial

Temsirolimus and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia

Terminated·NNational Cancer Institute (NCI)·Phase 1·NCT00101088·21 enrolled

Colorectal Cancer1 trial

Temsirolimus (CCI-770, Torisel) Combined With Cetuximab in Cetuximab-Refractory Colorectal Cancer

Completed·—·Phase 1·NCT00593060·35 enrolled

Gastrointestinal Stromal Tumor1 trial

CCI-779 in Treating Patients With Soft Tissue Sarcoma or Gastrointestinal Stromal Tumor

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00087074·55 enrolled

Metastatic Head and Neck Cancer1 trial

Temsirolimus With or Without Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer Who Did Not Respond to Previous Therapy

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01256385·86 enrolled

Hepatocellular Carcinoma1 trial

Phase II Combination of Temsirolimus and Sorafenib in Advanced Hepatocellular Carcinoma

Completed·UUniversity of California, San Francisco·Phase 2·NCT01687673·29 enrolled

Phase II1 trial

Phase II Study of Alternating Sunitinib and Temsirolimus

Completed·—·Phase 2·NCT01517243·37 enrolled

Acute Myeloid Leukemia1 trial

Clofarabine and Temsirolimus in Treating Older Patients With Relapsed or Refractory Acute Myeloid Leukemia

Completed·GGruppo Italiano Malattie EMatologiche dell'Adulto·Phase 2·NCT00775593·60 enrolled

Imaging1 trial

Temsirolimus-RCC-imaging

Unknown status·RRadboud University Medical Center·Phase 2·NCT01246817·51 enrolled

Waldenstrom macroglobulinemia1 trial

Bortezomib, Rituximab, and Dexamethasone With or Without Temsirolimus in Treating Patients With Untreated or Relapsed Waldenstrom Macroglobulinemia or Relapsed or Refractory Mantle Cell or Follicular Lymphoma

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT01381692·9 enrolled

Head and Neck Cancer1 trial

Efficacy Study of Temsirolimus to Treat Head and Neck Cancer

Completed·HHannover Medical School·Phase 2·NCT01172769·42 enrolled

Metastatic Melanoma1 trial

CCI-779 in Treating Patients With Metastatic Melanoma

Completed·—·Phase 2·NCT00022464

Protein Kinase Inhibitors1 trial

Evaluation of a Promising New Combination of Protein Kinase Inhibitors on Organotypic Cultures of Human Renal Tumors

Unknown status·UUniversity Hospital, Grenoble·N/A·NCT03571438·100 enrolled

Bladder Cancer1 trial

Phase II Evaluating Efficacy of Temsirolimus in 2 Line Therapy for Patients With Advanced Bladder Cancer

Completed·IInstitut Bergonié·Phase 2·NCT01827943·54 enrolled

Primary Peritoneal Cancer1 trial

Temsirolimus in Treating Patients With Refractory or Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00429793·60 enrolled

Neuroendocrine Carcinoma1 trial

Temsirolimus in Treating Patients With Metastatic Neuroendocrine Carcinoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00093782·36 enrolled

Metastatic Cancer1 trial

Cixutumumab and Temsirolimus in Treating Patients With Locally Advanced or Metastatic Cancer

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00678769·72 enrolled

Clear Cell Renal Carcinoma1 trial

Study in Non-Clear Cell Renal Carcinoma (Ncc-RCC) Temsirolimus Versus Sunitinib

Completed·CCentral European Society for Anticancer Drug Research·Phase 2·NCT00979966·22 enrolled

Myelodysplastic Syndrome1 trial

Temsirolimus in Myelodysplastic Syndrome (MDS)

Terminated·TTechnische Universität Dresden·Phase 2·NCT01111448·20 enrolled

Recurrent1 trial

Temsirolimus in Treating Patients With Recurrent or Persistent Cancer of the Uterus

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT01061606·8 enrolled

Recurrent or Refractory1 trial

Cixutumumab and Temsirolimus in Treating Younger Patients With Recurrent or Refractory Sarcoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01614795·46 enrolled

Advanced Cancers1 trial

Temsirolimus in Combination With Metformin in Patients With Advanced Cancers

Terminated·MM.D. Anderson Cancer Center·Phase 1·NCT01529593·34 enrolled

Tics1 trial

A Phase I, Open-Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6244 (ARRY-142886)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 1·NCT00600496·140 enrolled

Infusion1 trial

Superselective Intra-arterial Cerebral Infusion of Temsirolimus in HGG

Recruiting·NNader Sanai·Phase 1·NCT05773326·12 enrolled

Diffuse Intrinsic Pontine Glioma1 trial

Vorinostat and Temsirolimus With or Without Radiation Therapy in Treating Younger Patients With Newly Diagnosed or Progressive Diffuse Intrinsic Pontine Glioma

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT02420613·18 enrolled

Advanced Gynecological Malignancies1 trial

AZD2171 and Temsirolimus in Patients With Advanced Gynecological Malignancies

Completed·—·Phase 1·NCT01065662·11 enrolled

Cervical Cancer1 trial

Temsirolimus in Treating Patients With Cervical Cancer That Is Recurrent, Locally Advanced, Metastatic, or Cannot Be Removed By Surgery

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01026792·38 enrolled

Advanced Malignant Solid Neoplasm1 trial

A Phase I Trial of Dasatinib (PDGFR and SRC Inhibitor), Temsirolimus, and Cyclophosphamide in Patients With Advanced Solid Tumors

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT02389309·14 enrolled

Lymphoma, Non-Hodgkin1 trial

Targeted Agent and Profiling Utilization Registry (TAPUR) Study

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

Adult Solid Neoplasm1 trial

Phase I Study of Ixabepilone and Temsirolimus in Adult Patients With Advanced Solid Tumors

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT01375829·22 enrolled

Endometrial Adenocarcinoma1 trial

A Three Arm Randomized Phase II Study of Paclitaxel/Carboplatin/Bevacizumab (NSC #704865), Paclitaxel/Carboplatin/Temsirolimus (NSC #683864) and Ixabepilone (NSC #710428)/Carboplatin/Bevacizumab as Initial Therapy for Measurable Stage III or IVA, Stage IVB, or Recurrent Endometrial Cancer

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT00977574·349 enrolled

Desmoplastic Small Round Cell Tumor1 trial

Therapeutic Trial for Patients With Ewing Sarcoma Family of Tumor and Desmoplastic Small Round Cell Tumors

Completed·SSt. Jude Children's Research Hospital·Phase 2·NCT01946529·24 enrolled

Advanced or Metastatic Solid Tumors1 trial

Phase I Study of Temsirolimus and Cetuximab in Adults Patients With Advanced or Metastatic Solid Tumors

Completed·GGustave Roussy, Cancer Campus, Grand Paris·Phase 1·NCT02215720·45 enrolled

Metastatic Sarcoma1 trial

Pilot Trial of an Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Sarcomas

Recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT04199026·20 enrolled

Advanced Rare Tumours1 trial

A Phase II Study of Sunitinib or Temsirolimus in Patients With Advanced Rare Tumours

Active, not recruiting·CCanadian Cancer Trials Group·Phase 2·NCT01396408·137 enrolled

Advanced Malignant Neoplasm1 trial

A Phase I Study of the NovoTTF-100L(P) System to Enhance Antitumor Activity in Patients With Predominant Hepatic Metastatic Cancer

Terminated·MM.D. Anderson Cancer Center·Phase 1·NCT03203525·38 enrolled

Hepatoblastoma1 trial

Treatment of Children With All Stages of Hepatoblastoma With Temsirolimus (NSC#683864) Added to High Risk Stratum Treatment

Completed·NNational Cancer Institute (NCI)·Phase 3·NCT00980460·236 enrolled

Unspecified2 trials

Temsirolimus In Phase 0

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT01417065·15 enrolled

NCT Neuro Master Match - N²M² (NOA-20)

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

Regulatory

FDA Approval Timeline[5]

May 30, 2007

TORISEL

NDA NDA022088

Nov 9, 2007

TORISEL

NDA NDA022088

Apr 26, 2010

TORISEL

NDA NDA022088

Jul 9, 2010

TORISEL

NDA NDA022088

Jun 16, 2011

TORISEL

NDA NDA022088

Jun 16, 2011

TORISEL

NDA NDA022088

Jun 16, 2011

TORISEL

NDA NDA022088

Jun 16, 2011

TORISEL

NDA NDA022088

Jun 16, 2011

TORISEL

NDA NDA022088

Jun 16, 2011

TORISEL

NDA NDA022088

May 30, 2012

TORISEL

NDA NDA022088

Dec 20, 2013

TORISEL

NDA NDA022088

Apr 7, 2014

TORISEL

NDA NDA022088

Oct 7, 2014

TORISEL

NDA NDA022088

Feb 26, 2015

TORISEL

NDA NDA022088

Jul 27, 2016

TORISEL

NDA NDA022088

May 22, 2017

TORISEL

NDA NDA022088

Mar 23, 2018

TORISEL

NDA NDA022088

Mar 23, 2018

TORISEL

NDA NDA022088

Sources

References

[1]
ClinicalTrials.gov — 174 trial records for Temsirolimus. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Torisel drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Temsirolimus compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Temsirolimus. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA022088). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Torisel. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Prism Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: FK506-Binding Protein 1a Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: PPrism Pharmaceuticals

Patent Landscape[6]

Patent Cliff

May 10, 2032

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8026276Jan 20, 2026

8026276*PEDJul 20, 2026

8791097May 10, 2032

8791097*PEDNov 10, 2032