NCT01723800

PI3K Inhibitor BKM120, Carboplatin, and Pemetrexed Disodium in Treating Patients With Stage IV Non-Small Cell Lung Cancer

Phase I Trial of BKM120 in Combination With Carboplatin and Pemetrexed in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Recurrent Non-small Cell Lung Cancer
• Stage IV Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	PI3K inhibitor BKM120	Given PO
DRUG	pemetrexed disodium	Given IV
DRUG	carboplatin	Given IV
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	pharmacological study	Correlative studies
PROCEDURE	quality-of-life assessment	Ancillary studies

Timeline

• Start date: 2013-07-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2012-11-08
• Last updated: 2016-09-20

Locations

1 site across 1 country: United States