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Spots Global Cancer Trial Database for A Study to Investigate Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BKM120 Plus GSK1120212 in Selected Advanced Solid Tumor Patients

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Trial Identification

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

Official Title: A Phase Ib, Open-label, Multi-center, Dose-escalation Study of Oral BKM120 in Combination With Oral GSK1120212 in Adult Patients With Selected Advanced Solid Tumors.

Study ID: NCT01155453

Interventions

BKM120
GSK1120212

Study Description

Brief Summary: 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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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, Sevilla, Andalucia, Spain

Novartis Investigative Site, Barcelona, Catalunya, Spain

Novartis Investigative Site, Bellinzona, , Switzerland

Contact Details

Name: Novartis Pharmaceuticals

Affiliation: Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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