Protocol
11-157
Full Title
An Open Label Two-Stage Study of Orally Administered BKM120 in Patients with Metastatic Non-Small Cell Lung Cancer with Activated PI3K Pathway
Purpose
PI3 kinase (PI3K) is an enzyme which drives the growth and survival of some types of cancer. BKM120 is a drug designed to inhibit cancer growth by blocking PI3K.
The purpose of this study is to evaluate the safety and effectiveness of BKM120 in patients with metastatic non-small cell lung cancer that contains an activated PI3K pathway and cannot be cured with available treatment. BKM120 is a pill that is taken orally (by mouth).
Investigator
Co-Investigators
Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have metastatic non-small cell lung cancer that contains a mutation in the PI3KCA gene or PTEN gene or loss of the protein PTEN.
- Patients with squamous cell lung cancer must have disease that progressed despite one prior regimen of platinum-based chemotherapy.
- Patients with non-squamous cell lung cancer must have disease that progressed despite one or two prior regimens of chemotherapy.
- Patients with EGFR mutations must have had prior therapy with erlotinib or gefitinib.
- 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.
- This study is open to patients age 18 and older.
For more information about this study or to inquire about eligibility, please contact Dr. Paul K. Paik at 646-888-4202.
Disease(s)
Lung Cancer
Lung Cancer, Non-Small Cell
Lung Cancer, Non-Small Cell: Lung Adenocarcinoma
Locations
ClinicalTrials.gov
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