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BEZ235+ MEK162

Phase 1

Unspecified Adult Solid Tumor, Protocol Specific | Small molecule | Oncology |Pfizer, Inc.|Trials Updated: Oct 9, 2020

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment29

FDA Designations

No designations recorded

BEZ235+ MEK162 clinical trials

BEZ235+ MEK162 · 1 trial · 2 indications

Phase 1 1
NCT01337765Safety, Pharmacokinetics and Pharmacodynamics of BEZ235 Plus MEK162 in Selected Advanced Solid Tumor PatientsUnspecified Adult Solid Tumor, Protocol Specific
COMPLETED29 Analytics
PHASE1COMPLETED
Safety, Pharmacokinetics and Pharmacodynamics of BEZ235 Plus MEK162 in Selected Advanced Solid Tumor Patients
Unspecified Adult Solid Tumor, Protocol SpecificUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Dose Limiting Toxicities
during Cycle 1 of treatment with BEZ235 and MEK162

A complete treatment cycle is defined as 28 days of daily continuois treatment with study drug combination

Secondary Endpoints

Number of participants with adverse events and serious adverse events
from Cycle 1 Day 1 until treatment discontinuation
Overall response rate, duration of response, time to response and progression free survival
every 8 weeks of treatment
Time versus plasma concentration profiles of BEZ235 and MEK162
during the first cycle of treatment
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BEZ235 + MEK162EXPERIMENTAL -

Interventions

NameTypeDescription
BEZ235 + MEK162DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * histologically/cytologically confirmed, advanced non resectable solid tumors * Measurable or non-measurable, but evaluable disease as determined by RECIST 1.0 Exclusion Criteria: * Patients with primary CNS tumor or CNS tumor involvement * Diabetes mellitus - Unacceptable oc...

Countries:United StatesAustraliaCanadaFranceSpain
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Frequently asked questions about BEZ235+ MEK162

What is BEZ235+ MEK162?

BEZ235+ MEK162 is an investigational combination of two small molecule drugs studied together in oncology. It was evaluated in adults with advanced solid tumors. The combination was tested in a single Phase 1 clinical trial and is not an approved therapy.

What is BEZ235+ MEK162 used for?

BEZ235+ MEK162 was studied for the treatment of unspecified adult solid tumors. The research involved patients with advanced solid tumors, and the trial protocol did not restrict enrollment to a specific tumor type. It is an investigational combination and has not been approved for any indication.

Who is developing BEZ235+ MEK162?

Pfizer, Inc. is the developer of BEZ235+ MEK162. The company, which trades under the ticker PFE, sponsored the clinical research of this drug combination. Pfizer is a global pharmaceutical company.

What phase is BEZ235+ MEK162 in?

BEZ235+ MEK162 is in Phase 1 clinical development. It has completed one Phase 1 trial and is not currently active in any trials. The combination remains investigational and has not received FDA approval.

What clinical trials is BEZ235+ MEK162 in?

BEZ235+ MEK162 was evaluated in a single Phase 1 clinical trial, NCT01337765, titled "Safety, Pharmacokinetics and Pharmacodynamics of BEZ235 Plus MEK162 in Selected Advanced Solid Tumor Patients." The trial is completed and enrolled 29 participants across the United States, Australia, Canada, France, and Spain.