A Phase IB Study of BKM120 plus MEK162 in Select Patients with Advanced Solid Tumors

Protocol
11-117
Full 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
Purpose

The purpose of this study is to find the highest dose of the investigational drugs BKM120 and MEK162 that can be given together in patients with advanced solid tumors with particular molecular profiles that make them candidates for these drugs. BKM120 works by blocking a protein called PI3 kinase. MEK162 inhibits a protein called MEK1/2. Both proteins can cause cancer cells to grow faster.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have either (1) lung cancer with a KRAS mutation, (2) lung cancer with an EGFR mutation that is no longer sensitive to erlotinib or gefitinib, (3) lung cancer with a T790M mutation, or (4) ovarian cancer with a RAS (K, N, or H) or a RAF mutation.
  • Patients must have recovered from the side effects of prior therapies.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • Patients must be age 18 or older

For more information about this study and to inquire about eligibility, please contact Dr. Mrinal Gounder at 646-888-4167.

Disease(s)
Breast Cancer
Colorectal Cancer
Hepatobiliary: Pancreatic Cancer
Lung Cancer
Lung Cancer, Non-Small Cell
Lung Cancer, Non-Small Cell: Lung Adenocarcinoma
Upper Gastrointestinal: Pancreatic Cancer
Locations