Overview

This trial is active, not recruiting.

Conditions advanced solid tumors, selected solid tumors
Treatment bkm120 + mek162
Phase phase 1
Sponsor Array BioPharma
Start date August 2011
End date March 2014
Trial size 89 participants
Trial identifier NCT01363232, 2011-001083-22, CMEK162X2101

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
bkm120 + mek162

Primary Outcomes

Measure
Incidence of Dose Limiting Toxicities
time frame: during Cycle 1 of treatment with BKM120 and MEK162

Secondary Outcomes

Measure
Number of participants with adverse events and serious adverse events.
time frame: from Cycle 1 Day 1 until treatment discontinuation
Overall response rate, duration of response, time to response and progression free survival
time frame: every 8 weeks of treatment
Time versus plasma concentration profiles of BKM120 and MEK162
time frame: 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.
time frame: during the first cycle of treatment on Cycle 1 Day 15 and at disease progression

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histologically/ cytologically confirmed, advanced non resectable solid tumors - Measurable or non-measurable, but evaluable disease as determined by RECIST Exclusion Criteria: - Patients with primary CNS tumor or CNS tumor involvement. - Diabetes mellitus - Unacceptable ocular/retinal conditions

Additional Information

Official title A Phase Ib, Open-label, Multi-center, Dose-escalation and Expansion Study of an Orally Administered Combination of BKM120 Plus MEK162 in Adult Patients With Selected Advanced Solid Tumors
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Array BioPharma.