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BEZ235+ paclitaxel

Phase 1

Metastatic or Locally Advanced Solid Tumors | Small molecule | Oncology |Novartis AG|Last Updated: Dec 9, 2020

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment110

FDA Designations

No designations recorded

Clinical trial landscape

BEZ235+ paclitaxel · 1 trial · 1 indication

Phase 1 1
NCT01285466A Trial of Oral BEZ235 and BKM120 in Combination With Paclitaxel With or Without TrastuzumabMetastatic or Locally Advanced Solid Tumors
COMPLETED110 Analytics
PHASE1COMPLETED
A Trial of Oral BEZ235 and BKM120 in Combination With Paclitaxel With or Without Trastuzumab
Metastatic or Locally Advanced Solid Tumors
NCT01285466110
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Study Endpoints

Primary Endpoints

Incidence of Dose limiting toxicities during the first cycle of treatment.
First treatment cycle (4 weeks)

Secondary Endpoints

Incidence of safety events during the whole treatment period (until progression of disease).
From start of treatment until disease progression
pharmacokinetics of BEZ235, BKM120 and paclitaxel given in combination, on Day 1, 8 and 22.
First treatment cycle (4 weeks)
Treatment efficacy (response to treatment according to RECIST criteria)
From start of treatment until disease progression
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BEZ235 + paclitaxelEXPERIMENTAL -
BKM120 + paclitaxelEXPERIMENTAL -
BEZ235 + paclitaxel + trastuzumabEXPERIMENTAL -
BKM120 + paclitaxel + trastuzumabEXPERIMENTAL -

Interventions

NameTypeDescription
BEZ235 + paclitaxelDRUG -
BKM120 + paclitaxelDRUG -
BEZ235 + paclitaxel + trastuzumabDRUG -
BKM120 + paclitaxel + trastuzumabDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: * Adult patients with metastatic or locally advanced solid tumors, for whom weekly paclitaxel treatment is indicated (BEZ235-paclitaxel /BKM120-paclitaxel treatment) * HER2+ metastatic or locally advanced breast cancer patients eligible for weekly paclitaxel and trastuzumab (BEZ...

Countries:BelgiumGermanyNetherlandsSpainSwitzerland
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Frequently asked questions about BEZ235+ paclitaxel

What is BEZ235 used for?

BEZ235 is an investigational small molecule being studied in oncology for multiple tumor types, including pancreatic neuroendocrine tumors (pNET), advanced solid tumors, breast cancer, locally advanced breast cancer (LABC), castration-resistant prostate cancer, and metastatic or locally advanced solid tumors. It is not approved and remains in clinical development.

Who makes BEZ235?

BEZ235 is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker NVS. The drug is an investigational small molecule in the oncology therapeutic area.

What phase is BEZ235 in?

BEZ235 is in Phase 1 clinical development. All completed trials for the drug are Phase 1 studies. It is investigational and has not received FDA approval, as it remains under clinical investigation for various solid tumor indications.

What clinical trials is BEZ235 in?

BEZ235 has been studied in several completed Phase 1 trials, including NCT00620594 in advanced solid malignancies and breast cancer, NCT01195376 in Japanese patients with advanced solid tumors, NCT01471847 in HER2-positive breast cancer with trastuzumab, and NCT01634061 in castration-resistant prostate cancer with abiraterone acetate.

Is BEZ235 the same as other names?

BEZ235 is the primary name for this investigational drug. No alternative names have been established in the clinical trial data, so it is consistently referred to as BEZ235 across studies.