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2011-08
2014-03
2017-12-18
89
NCT01363232
Array BioPharma
Array BioPharma
INTERVENTIONAL
Safety, Pharmacokinetics and Pharmacodynamics of BKM120 Plus MEK162 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 the recommended phase II dose (RP2D) of the orally administered phosphatidylinositol 3'-kinase (PI3K) inhibitor BKM120 in combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients with epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC) which has progressed on EGFR inhibitors and triple negative breast cancer, as well as pancreatic cancer, colorectal cancer, malignant melanoma, NSCLC, and other advanced solid tumors with KRAS, NRAS, and/or BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. At MTD or RP2D, two expansion arms will be opened in order to further assess safety and preliminary anti-tumor activity of the combination of BKM120 and MEK162. Study drugs will be administered once daily orally on a continuous schedule. A treatment cycle is defined as 28 days.
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 |
|---|---|---|
2011-05-24 | N/A | 2020-09-30 |
2011-05-31 | N/A | 2020-10-05 |
2011-06-01 | N/A | 2020-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: BKM120 + MEK162 | DRUG: BKM120 + MEK162 |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Incidence of Dose Limiting Toxicities | during Cycle 1 of treatment with BKM120 and MEK162 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of participants with adverse events and serious adverse events. | from Cycle 1 Day 1 until treatment discontinuation | |
| Overall response rate, duration of response, time to response and progression free survival | every 8 weeks of treatment | |
| Time versus plasma concentration profiles of BKM120 and MEK162 | during the first cycle of treatment on Cycle 1 Day 1 and Cycle 1 Day 15 | |
| Treatment -induced PI3K and MEK/ERK pathway signaling inhibition and evidence of biological activity in tumor. | during the first cycle of treatment on Cycle 1 Day 15 and at disease progression |
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
