Recent Updates
Recently added Catalysts

BEZ235+ MEK162

Phase 1

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment29

FDA Designations

No designations recorded

Clinical trial landscape

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
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BEZ235 + MEK162EXPERIMENTAL -

Interventions

NameTypeDescription
BEZ235 + MEK162DRUG -
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about BEZ235+ MEK162

What is BEZ235+MEK162 used for?

BEZ235+MEK162 is an investigational combination of two small molecules being studied for the treatment of unspecified adult solid tumors, as defined by the specific protocol. It is being developed by Pfizer, Inc. for oncology indications. The combination is currently in clinical development, with a Phase 1 trial completed.

Who makes BEZ235+MEK162?

BEZ235+MEK162 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical research on this combination therapy for the treatment of solid tumors in adult patients.

What phase is BEZ235+MEK162 in?

BEZ235+MEK162 is in Phase 1 clinical development. A Phase 1 trial has been completed, which evaluated the safety, pharmacokinetics, and pharmacodynamics of the combination in patients with selected advanced solid tumors. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is BEZ235+MEK162 in?

BEZ235+MEK162 has been studied in one clinical trial, registered as NCT01337765. This Phase 1 study, titled "Safety, Pharmacokinetics and Pharmacodynamics of BEZ235 Plus MEK162 in Selected Advanced Solid Tumor Patients," has been completed. The trial enrolled 29 participants across the United States, Australia, Canada, France, and Spain.

Is BEZ235+MEK162 a randomized or blinded study?

The completed Phase 1 trial of BEZ235+MEK162 was not randomized and was not double-blinded. It was an uncontrolled study, meaning there was no control group receiving a placebo or standard treatment. The trial enrolled 29 patients with advanced solid tumors.

What is the mechanism of action of BEZ235+MEK162?

BEZ235+MEK162 is a combination of two small molecule drugs. BEZ235 is a dual inhibitor of PI3K and mTOR, while MEK162 is a MEK inhibitor. Together, they target multiple signaling pathways involved in tumor growth. The combination is being studied for its potential effect on advanced solid tumors.