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2010-04
2014-11
2014-11
113
NCT01155453
Novartis
Novartis
INTERVENTIONAL
A Study to Investigate Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BKM120 Plus GSK1120212 in Selected Advanced Solid Tumor Patients
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
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2010-06-17 | N/A | 2020-12-06 |
2010-06-30 | N/A | 2020-12-09 |
2010-07-01 | N/A | 2016-06 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: BKM120 + GSK1120212 DE Dose Escalation | DRUG: BKM120 DRUG: GSK1120212 |
| EXPERIMENTAL: BKM120 + GSK1120212 NSCLC patients Advanced RAS or BRAF mutant NSCLC patients | DRUG: BKM120 DRUG: GSK1120212 |
| EXPERIMENTAL: BKM120 + GSK1120212 ovarian cancer patients Advanced RAS or BRAF mutant ovarian cancer patients | DRUG: BKM120 DRUG: GSK1120212 |
| EXPERIMENTAL: BKM120 + GSK1120212 pancreatic cancer patients Advanced RAS or BRAF mutant pancreatic cancer patients | DRUG: BKM120 DRUG: GSK1120212 |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) and/or recommended phase II dose (RP2D) and schedule of BKM120+GSK1120212 | in average 1 year |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 | 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 | Assessed during the first Cycle (28 days) of treatment | |
| Preliminary anti-tumor activity of the combination | 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 | 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 | Assessed at baseline (pre-treatment) |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
