Cisplatin, Etoposide and PI3K Inhibitor BKM120 in Treating Patients With Advanced Solid Tumors or Small Cell Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02194049|
Recruitment Status : Completed
First Posted : July 18, 2014
Last Update Posted : January 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Extensive Stage Small Cell Lung Cancer Unspecified Adult Solid Tumor, Protocol Specific||Drug: BKM120 Drug: cisplatin Drug: etoposide||Phase 1|
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).
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of Cisplatin and Etoposide Plus BKM120 in Advanced Solid Tumors, With an Emphasis on Small Cell Lung Cancer|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||June 2016|
Experimental: BKM 120, cisplatin, etoposide
Patients receive PI3K Inhibitor BKM120 PO QD on days 1-21, cisplatin 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.
Other Name: PI3K_Inhibitor_BKM120
- Incidence of adverse events of combining daily BKM120 with cisplatin and etoposide as graded by the National Cancer Institute (NC) CTCAE version 4.0 [ Time Frame: Up to 28 days post-treatment ]The toxicities observed at each dose level will be summarized in terms of type (organ affected or laboratory determination such as absolute neutrophil count), severity, time of onset (i.e. course number), duration, and reversibility or outcome.
- MTD defined as the highest dose tested in which fewer than 33% of patients experience DLT attributed to the study drugs when at least 6 patients were treated at that dose, as graded by NCI CTCAE version 4.0 [ Time Frame: 21 days ]The toxicities observed at each dose level will be summarized in terms of type (organ affected or laboratory determination such as absolute neutrophil count), severity, time of onset (i.e. course number), duration, and reversibility or outcome.
- Response rate assessed by computed tomography (CT) scan based on Response Evaluation Criteria In Solid Tumors (RECIST) [ Time Frame: Up to 30 days ]Response rate among patients with measurable disease will be summarized by exact binomial confidence intervals
- Overall survival [ Time Frame: Up to 30 days ]Survival will be summarized with Kaplan-Meier plots to describe the outcome of patients treated on this protocol. Median survival time will be estimated using standard life table methods.
- Time to progression (TTP) based on RECIST [ Time Frame: Up to 30 days ]TTP will be summarized with Kaplan-Meier plots to describe the outcome of patients treated on this protocol. Median time to progression will be estimated using standard life table methods.
- Pharmacokinetic analysis [ Time Frame: Baseline, at 1, 2, 4, 6, and 24 hours of day 1 of course 1, baseline day 15 of course 1, and at 1 and 2 hours post-dose on day 1 of course 2 ]Pharmacokinetic analysis will use non-linear curve fitting methods to estimate the mean peak concentration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02194049
|United States, California|
|University of California at Davis Cancer Center|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Karen Kelly||University of California, Davis|