Stage IV Non-small Cell Lung Cancer Clinical Trial
Official title:
Phase I Trial of BKM120 in Combination With Carboplatin and Pemetrexed in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
This phase I trial studies the side effects and best dose of PI3K inhibitor BKM120 when given together with carboplatin and pemetrexed disodium in treating patients with stage IV non-small cell lung cancer. PI3K inhibitor BKM120 and pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving PI3K inhibitor BKM120, carboplatin, and pemetrexed disodium together may kill more tumor cells
PRIMARY OBJECTIVES:
I. To determine the recommended phase 2 dose (RP2D) of BKM120 (PI3K inhibitor BKM120) that
can be administered in combination with carboplatin and pemetrexed (pemetrexed disodium) in
patients with advanced non-squamous non-small cell lung cancer (NSCLC).
II. To define the dose-limiting toxicity (DLT) and other toxicities associated with the use
of combination BKM120 and carboplatin and pemetrexed.
SECONDARY OBJECTIVES:
I. To evaluate the pharmacokinetic parameters of BKM120, when used in combination with
carboplatin and pemetrexed.
II. To obtain preliminary evidence of anti-tumor activity with this combination.
III. To evaluate downstream inhibition of the phosphatidylinositol 3 kinase (PI3K) pathway.
OUTLINE: This is a dose-escalation study of PI3K inhibitor BKM120. Patients receive
pemetrexed disodium intravenously (IV) over 10 minutes followed by carboplatin IV over 30
minutes on day 1, and PI3K inhibitor BKM120 orally (PO) once daily (QD) on days 1-21.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients may receive courses of PI3K inhibitor BKM120 alone or PI3K inhibitor BKM120 and
pemetrexed disodium after 4-6 courses with carboplatin in the absence of unacceptable
toxicity or disease progression.
After completion of study treatment, patients are followed up for 28 days.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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