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A Study to Investigate Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BKM120 Plus GSK1120212 in Selected Advanced Solid Tumor Patients

NCT ID: NCT01155453

Last Updated: 2020-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2014-11-30

Brief Summary

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This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and /or recommended phase II dose (RP2D) and schedule for the PI3K (Phosphatidylinositol 3-Kinase) inhibitor BKM120 given in combination with the MEK inhibitor GSK1120212 in patients with selected, advanced solid tumors. The focus will be on tumors with RAS/RAF mutations and on triple negative breast cancer.

Both study drugs will be administered once daily orally on a continuous schedule, a treatment cycle is defined as 28 days.

Cohorts of at least 3 and up to a maximum of 6 patients eligible for the dose-determining set will be enrolled per dose combination below the MTD. The MTD is defined as the highest drug dosage not causing in the first cycle of treatment medically unacceptable, dose-limiting toxicity (DLT) in more than 33% of the treated patients.. At least 12 patients will be required at MTD and 6 patients at RP2D level to allow the evaluation of the combination's safety and pharmacokinetics or pharmacodynamics.

Upon declaration of MTD and/or RP2D, patients will be enrolled to an expansion part of the study, to further assess safety, as well as to learn more about the efficacy of the study drug combination.

* Expansion Arm 1 will consist of approximately 15 patients with RAS or BRAF mutant advanced NSCLC
* Expansion Arm 2 will consist of approximately 15 patients with RAS or BRAF-mutant ovarian cancer
* Expansion Arm 3 will consist of approximately 15 patients with RAS or BRAF-mutant pancreatic cancer

Detailed Description

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Conditions

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Advanced and Selected Solid Tumors

Keywords

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BKM120 RAS RAF mutations, triple negative breast cancer, pancreatic cancer, PI3K inhibitor, MEK inhibitor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BKM120 + GSK1120212 DE

Dose Escalation

Group Type EXPERIMENTAL

BKM120

Intervention Type DRUG

GSK1120212

Intervention Type DRUG

BKM120 + GSK1120212 NSCLC patients

Advanced RAS or BRAF mutant NSCLC patients

Group Type EXPERIMENTAL

BKM120

Intervention Type DRUG

GSK1120212

Intervention Type DRUG

BKM120 + GSK1120212 ovarian cancer patients

Advanced RAS or BRAF mutant ovarian cancer patients

Group Type EXPERIMENTAL

BKM120

Intervention Type DRUG

GSK1120212

Intervention Type DRUG

BKM120 + GSK1120212 pancreatic cancer patients

Advanced RAS or BRAF mutant pancreatic cancer patients

Group Type EXPERIMENTAL

BKM120

Intervention Type DRUG

GSK1120212

Intervention Type DRUG

Interventions

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BKM120

Intervention Type DRUG

GSK1120212

Intervention Type DRUG

Eligibility Criteria

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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 Central Nervous System (CNS) tumor or CNS tumor involvement.
* Clinically manifested diabetes mellitus - Unacceptable ocular/retinal conditions
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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University of California at Los Angeles Div. of Hematology/Oncology

Los Angeles, California, United States

Site Status

University of Texas/MD Anderson Cancer Center Dept of MD Anderson (8)

Houston, Texas, United States

Site Status

Novartis Investigative Site

Leuven, , Belgium

Site Status

Novartis Investigative Site

Toronto, Ontario, Canada

Site Status

Novartis Investigative Site

Seville, Andalusia, Spain

Site Status

Novartis Investigative Site

Barcelona, Catalonia, Spain

Site Status

Novartis Investigative Site

Bellinzona, , Switzerland

Site Status

Countries

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United States Belgium Canada Spain Switzerland

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=13963

Results for CBKM120B2101 on the Novartis Clinical Trial website

Other Identifiers

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2009-017157-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CBKM120B2101

Identifier Type: -

Identifier Source: org_study_id