A Phase 1 interventional study of BKM120 and GSK1120212 in Advanced and Selected Solid Tumors, sponsored by Novartis Pharmaceuticals. Completed at 7 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-09.
Sponsored by Novartis Pharmaceuticals · Phase 1, Interventional, and Treatment
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
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Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Dose Escalation
Drug: BKM120 · Drug: GSK1120212
Advanced RAS or BRAF mutant NSCLC patients
Drug: BKM120 · Drug: GSK1120212
Advanced RAS or BRAF mutant ovarian cancer patients
Drug: BKM120 · Drug: GSK1120212
Advanced RAS or BRAF mutant pancreatic cancer patients
Drug: BKM120 · Drug: GSK1120212
Maximum Tolerated Dose (MTD) and/or recommended phase II dose (RP2D) and schedule of BKM120+GSK1120212
Time frame: in average 1 year
Measure the number of Adverse Event and laboratory values that fall outside of pre-determined ranges as a measure of Safety and tolerability of the oral combination of BKM120 and GSK1120212
Time frame: in average 1 year
Determine the single and multiple dose pharmacokinetics of BKM120 and GSK1120212 in measurement of the plasma concentration profiles of BKM120 and GSK1120212
Time frame: Assessed during the first Cycle (28 days) of treatment
Preliminary anti-tumor activity of the combination
Time frame: Assessed every 8 weeks of treatment
Treatment-induced PI3K and MEK/ERK(Mitogen-activated protein kinase /extracellular-signal-regulated kinases) pathway signaling inhibition and evidence of biological activity in tumor and skin
Time frame: Assessed every 2 weeks during the first cycle, then every 4 weeks
Molecular status (genetic alterations, protein expression and/or activation) of markers related to PI3K and ERK signaling in tumor tissue and blood and investigate their potential relationship to clinical responses
Time frame: Assessed at baseline (pre-treatment)
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals