NCT01363232

Safety, Pharmacokinetics and Pharmacodynamics of BKM120 Plus MEK162 in Selected Advanced Solid Tumor Patients

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Array Biopharma, now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumors
• Selected Solid Tumors

Interventions

Type	Name	Description
DRUG	BKM120 + MEK162

Timeline

• Start date: 2011-08-01
• Primary completion: 2014-03-01
• Completion: 2017-12-18
• First posted: 2011-06-01
• Last updated: 2020-10-05

Locations

12 sites across 7 countries: United States, Canada, Germany, Netherlands, Singapore, Spain, Switzerland