BEZ235

Phase 2Small molecule

Novartis

BEZ235 is one of 276 small molecule programs targeting PEComa. It is currently in Phase 2.

Indications

Total Trials

Active Trials

275

Competitors

Pipeline

Status by Indication[3][1]

Indication

PecomaActive, not recruiting

Respiratory Tract InfectionActive, not recruiting

Transitional Cell CarcinomaActive, not recruiting

Pancreatic Neuroendocrine TumorActive, not recruiting

Endometrial CarcinomaActive, not recruiting

Breast CancerActive, not recruiting

Prostate CancerActive, not recruiting

Renal Cell CarcinomaActive, not recruiting

Acute LeukemiaActive, not recruiting

PecomaPhase 2

Active, not recruiting

Respiratory Tract InfectionPhase 2

Active, not recruiting

Transitional Cell CarcinomaPhase 2

Active, not recruiting

Pancreatic Neuroendocrine TumorPhase 2

Active, not recruiting

Endometrial CarcinomaPhase 2

Active, not recruiting

Breast CancerPhase 1

Active, not recruiting

Prostate CancerPhase 1

Active, not recruiting

Renal Cell CarcinomaPhase 1/Phase 2

Active, not recruiting

Acute LeukemiaPhase 1

Active, not recruiting

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Tykerb

GSK

Preclinical

80 2

Halaven

Eisai

Preclinical

38 3

BEZ235

Novartis

Phase 2

4 4

Adriamycin

GGynecologic Oncology Group

Preclinical

87 5

Avastin

BBio-Thera Solutions

Preclinical

153 6

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Preclinical

78 7

Prolia

Amgen

Preclinical

14 8

Gemzar

GGynecologic Oncology Group

Preclinical

22 9

MS Contin

Merck & Co.

Preclinical

2 10

Voltaren

Novartis

Preclinical

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

Clinical

Trials by Indication[1]

Breast Cancer4 trials

BEZ235 Trial in Patients With HER2-(Human Epidermal Growth Factor Receptor 2 Negative) /HR+ (Hormonal Receptor Positive) Metastatic Breast Cancer

Withdrawn· Novartis logo

Novartis·Phase 2·NCT01288092

A Phase I/II Study of BEZ235 in Patients With Advanced Solid Malignancies Enriched by Patients With Advanced Breast Cancer

Completed· Novartis logo

Novartis·Phase 1·NCT00620594·183 enrolled

Phase Ib/II Trial of BEZ235 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer

Terminated· Novartis logo

Novartis·Phase 1/2·NCT01495247·18 enrolled

Show 1 more trial

PhIb BKM120 or BEZ235+Endocrine Treatment in Post-Menopausal Patients With Hormone Receptor + Metastatic Breast Cancer

Completed·VVanderbilt-Ingram Cancer Center·Phase 1·NCT01248494·72 enrolled

Pancreatic Neuroendocrine Tumor2 trials

Efficacy and Safety of BEZ235 Compared to Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumors

Terminated· Novartis logo

Novartis·Phase 2·NCT01628913·62 enrolled

BEZ235 Phase II Trial in Patients With Advanced Pancreatic Neuroendocrine Tumors (pNET) After Failure of mTOR Inhibitor Therapy.

Completed· Novartis logo

Novartis·Phase 2·NCT01658436·31 enrolled

Prostate Cancer2 trials

A Multicenter Phase I/II Trial of Abiraterone Acetate + BEZ235 in Metastatic, Castration-Resistant Prostate Cancer

Terminated·CCharles Ryan·Phase 1/2·NCT01717898·6 enrolled

Phase Ib of Abiraterone Acetate Plus BEZ235 or BKM120 in Castration-resistant Prostate Cancer (CRPC) Patients

Completed· Novartis logo

Novartis·Phase 1·NCT01634061·43 enrolled

Advanced Solid Tumors2 trials

Study of PI3 Kinase/mTOR Inhibitor BEZ235 Twice Daily for Advanced Solid Tumors

Completed·SSCRI Development Innovations, LLC·Phase 1·NCT01343498·33 enrolled

Safety Study of BEZ235 With Everolimus in Subjects With Advanced Solid Tumors

Terminated·UUniversity of Cincinnati·Phase 1·NCT01508104·19 enrolled

Renal Cell Carcinoma1 trial

BEZ235 in Patients With Advanced Renal Cell Carcinoma (RCC)

Terminated·MMemorial Sloan Kettering Cancer Center·Phase 1/2·NCT01453595·10 enrolled

6 more indications

Patients With Advanced Solid Tumors1 trial

A Study of BEZ235 in Adult Japanese Patients With Advanced Solid Tumors

Completed· Novartis logo

Novartis·Phase 1·NCT01195376·35 enrolled

Respiratory tract infection1 trial

Dose Finding Study to Determine if BEZ235 Alone or in Combination With RAD001 Decreases the Incidence of Respiratory Tract Infections in the Elderly

Active, not recruiting·RRestorbio Inc.·Phase 2·NCT03373903·652 enrolled

Endometrial Carcinoma1 trial

BEZ235 Trial in Patients With Advanced Endometrial Carcinoma

Withdrawn· Novartis logo

Novartis·Phase 2·NCT01290406

Acute Leukemia1 trial

A Phase I, Dose-finding Study of BEZ235 in Adult Patients With Relapsed or Refractory Acute Leukemia

Completed·GGoethe University·Phase 1·NCT01756118·24 enrolled

Transitional Cell Carcinoma1 trial

Study of BEZ235 as Monotherapy in Patients With Transitional Cell Carcinoma After Failure of Platinum Based Chemotherapy

Terminated·CCliniques universitaires Saint-Luc- Université Catholique de Louvain·Phase 2·NCT01856101·22 enrolled

PEComa1 trial

A Phase II Study of Orally Administered BEZ235 Monotherapy in Patients With Metastatic or Unresectable Malignant PEComa

Withdrawn· Novartis logo

Novartis·Phase 2·NCT01690871

Sources

References

[1]
ClinicalTrials.gov — 17 trial records for BEZ235. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — BEZ235 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for BEZ235. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: Novartis

BEZ235

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Breast Cancer4 trials

Pancreatic Neuroendocrine Tumor2 trials

Prostate Cancer2 trials

Advanced Solid Tumors2 trials

Renal Cell Carcinoma1 trial

Patients With Advanced Solid Tumors1 trial

Respiratory tract infection1 trial

Endometrial Carcinoma1 trial

Acute Leukemia1 trial

Transitional Cell Carcinoma1 trial

PEComa1 trial

References

Drug Info

Quick Facts

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