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BKM120+ MEK162

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Oct 5, 2020

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment89

FDA Designations

No designations recorded

Clinical trial landscape

BKM120+ MEK162 · 1 trial · 2 indications

Phase 1 1
NCT01363232Safety, Pharmacokinetics and Pharmacodynamics of BKM120 Plus MEK162 in Selected Advanced Solid Tumor PatientsAdvanced Solid Tumors
COMPLETED89 Analytics
PHASE1COMPLETED
Safety, Pharmacokinetics and Pharmacodynamics of BKM120 Plus MEK162 in Selected Advanced Solid Tumor Patients
Advanced Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Dose Limiting Toxicities
during Cycle 1 of treatment with BKM120 and MEK162

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 BKM120 and MEK162
during the first cycle of treatment on Cycle 1 Day 1 and Cycle 1 Day 15
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BKM120 + MEK162EXPERIMENTAL -

Interventions

NameTypeDescription
BKM120 + MEK162DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites12

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

Countries:United StatesCanadaGermanyNetherlandsSingaporeSpainSwitzerland
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumors")

Frequently asked questions about BKM120+ MEK162

What is BKM120+ MEK162 used for?

BKM120+ MEK162 is an investigational combination of two small molecules being studied for the treatment of advanced solid tumors. It is intended for patients with selected solid tumors that have progressed despite prior therapy. The combination is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

How does BKM120+ MEK162 work?

BKM120+ MEK162 combines two targeted small molecule agents. BKM120 is a PI3K inhibitor, and MEK162 is a MEK inhibitor. By blocking these two signaling pathways, the combination aims to inhibit tumor cell growth and survival in advanced solid tumors. The exact mechanism of action is under investigation in clinical trials.

Who is developing BKM120+ MEK162?

BKM120+ MEK162 is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the safety and efficacy of this combination in patients with advanced solid tumors.

What phase is BKM120+ MEK162 in?

BKM120+ MEK162 is in Phase 1 clinical development. It is an investigational combination therapy that has not yet been approved by the FDA or other regulatory agencies. The Phase 1 trial is designed to assess safety, pharmacokinetics, and pharmacodynamics in patients with advanced solid tumors.

What clinical trials is BKM120+ MEK162 in?

BKM120+ MEK162 has been studied in one completed Phase 1 clinical trial with the identifier NCT01363232. The trial, titled 'Safety, Pharmacokinetics and Pharmacodynamics of BKM120 Plus MEK162 in Selected Advanced Solid Tumor Patients,' enrolled 89 participants across multiple countries including the United States, Canada, Germany, and others.

Is BKM120+ MEK162 the same as other drug names?

BKM120+ MEK162 is a combination of two drugs: BKM120 (buparlisib) and MEK162 (binimetinib). These are the generic names for the individual agents. The combination is being studied together for advanced solid tumors, but each drug is also developed separately for other indications.