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BKM120+ MEK162

Phase 1

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

BKM120+ MEK162 target and mechanism

ModalitySmall molecule

Also known as BKM120

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment89

FDA Designations

No designations recorded

BKM120+ MEK162 clinical trials

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 10 trials (matched to "Advanced Solid Tumors")

Frequently asked questions about BKM120+ MEK162

What is BKM120 + MEK162?

BKM120 + MEK162 is an investigational combination of two small molecule drugs studied together in oncology. It was tested in patients with selected advanced solid tumors. The combination is not approved and remains in clinical development. It was evaluated in a single Phase 1 trial that has been completed.

What is BKM120 + MEK162 used for?

BKM120 + MEK162 was studied for the treatment of selected advanced solid tumors. The Phase 1 trial enrolled patients with advanced solid tumors and selected solid tumor types. It is an investigational combination and is not an approved treatment for any indication.

Who makes BKM120 + MEK162?

BKM120 + MEK162 is being developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the company associated with the development of this drug combination. The combination was evaluated in a single Phase 1 clinical trial.

What phase is BKM120 + MEK162 in?

BKM120 + MEK162 is in Phase 1 development. The only trial of this combination was a Phase 1 study, and it has been completed. The combination is investigational and has not been approved by the FDA for any indication.

What clinical trials is BKM120 + MEK162 in?

BKM120 + MEK162 was studied in one clinical trial, NCT01363232, titled Safety, Pharmacokinetics and Pharmacodynamics of BKM120 Plus MEK162 in Selected Advanced Solid Tumor Patients. That Phase 1 trial is completed and enrolled 89 patients across the United States, Canada, Germany, Netherlands, Singapore, Spain, and Switzerland.

Is BKM120 + MEK162 the same as BKM120?

BKM120 + MEK162 is a combination regimen that includes BKM120, so searches for BKM120 may refer to this combination study. The trial NCT01363232 evaluated BKM120 plus MEK162 together in patients with selected advanced solid tumors. BKM120 + MEK162 is also written as BKM120 + MEK162.