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

Completed · Phase 1

Conditions studied: Advanced and Selected Solid Tumors

In brief

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

Key facts

Study ID: NCT01155453
Run by: Novartis Pharmaceuticals
People needed: 113
Starts: 2010-04-01
Expected to finish: 2014-11-01
Last updated by the study team: 2020-12-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

histologically/ cytologically confirmed, advanced non resectable solid tumors
Measurable or non-measurable, but evaluable disease as determined by RECIST 1.0

You may not qualify if…

Patients with primary Central Nervous System (CNS) tumor or CNS tumor involvement.
Clinically manifested diabetes mellitus - Unacceptable ocular/retinal conditions
Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

University of California at Los Angeles Div. of Hematology/Oncology — Los Angeles, California, United States
University of Texas/MD Anderson Cancer Center Dept of MD Anderson (8) — Houston, Texas, United States
Novartis Investigative Site — Leuven, Belgium
Novartis Investigative Site — Toronto, Ontario, Canada
Novartis Investigative Site — Seville, Andalusia, Spain
Novartis Investigative Site — Barcelona, Catalonia, Spain
Novartis Investigative Site — Bellinzona, Switzerland

Full record on ClinicalTrials.gov

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