Other Clinical Trial - Cisplatin, Etoposide & PI3K Inhibitor BKM120 in

Status Completed

Clinical Trial Summary

This phase I trial studies the side effects and the best dose of PI3K inhibitor BKM120 when given together with cisplatin and etoposide in treating patients with advanced solid tumors or small cell lung cancer. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing , or by stopping them from spreading. PI3K inhibitor BKM120 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving PI3K inhibitor BKM120 with cisplatin and etoposide may kill more tumor cells.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine the safety and feasibility of combining BKM120 (PI3K inhibitor BKM120) with cisplatin and etoposide in advanced solid tumors, with emphasis on small cell lung cancer (SCLC).

SECONDARY OBJECTIVE:

I. To determine the MTD (maximally tolerated dose) of BKM120 in combination with cisplatin/etoposide.

II. To describe the dose limiting toxicities (DLT) and toxicity profile associated with BKM120 in combination with cisplatin/etoposide.

III. To determine the preliminary efficacy of BKM120 in combination with cisplatin/etoposide in an expanded cohort of patients with SCLC.

IV. To characterize the pharmacokinetic (PK) parameters of BKM120 in this combination.

V. To collect blood samples for future exploratory biomarker analysis.

OUTLINE: This is a dose-escalation study of PI3K inhibitor BKM120.

Patients receive PI3K Inhibitor BKM120 orally (PO) once daily (QD) on days 1-21, cisplatin intravenously (IV) over 2 hours on day 1 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of treatment, patients are followed for 30 days. ;

Study Design

Related Conditions & MeSH terms

Extensive Stage Small Cell Lung Cancer
Lung Neoplasms
Small Cell Lung Carcinoma
Unspecified Adult Solid Tumor, Protocol Specific

Clinical Trial Details

NCT number	NCT02194049
Study type	Interventional
Source	University of California, Davis
Contact
Status	Completed
Phase	Phase 1
Start date	July 2014
Completion date	June 2016

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Cisplatin, Etoposide and PI3K Inhibitor BKM120 in Treating Patients With Advanced Solid Tumors or Small Cell Lung Cancer

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms