NCT01971489

Buparlisib, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Advanced Solid Tumors

A Phase I Study of the PI3-Kinase Inhibitor BKM120 in Combination With Gemcitabine and Cisplatin in Patients With Advanced Solid Tumors

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and the best doses of buparlisib, gemcitabine hydrochloride, and cisplatin in treating patients with solid tumors that have spread to other places in the body. Buparlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving buparlisib, gemcitabine hydrochloride, and cisplatin may be a better treatment for solid tumors.

Detailed description

PRIMARY OBJECTIVES: I. To describe the dose-limiting toxicities, maximally tolerated dose, and identify the recommended Phase II dose (RP2D) of the combination of BKM120 (buparlisib), gemcitabine (gemcitabine hydrochloride), and cisplatin in patients with advanced solid tumors. SECONDARY OBJECTIVES: I. To describe safety and tolerability of the combination of BKM120, gemcitabine, and cisplatin in patients with advanced solid tumors. II. To describe preliminary evidence of efficacy with this combination. III. To describe any pharmacokinetic (PK) effect of gemcitabine and cisplatin on the plasma concentrations of BKM120. IV. To evaluate phosphatidylinositol-4, 5-bisphosphate 3-kinase, catalytic subunit alpha (PIK3CA) mutations as predictive biomarkers of efficacy for the combination. V. To evaluate PIK3CA polymorphisms and polymorphisms in BKM120 transport and metabolism as predictors of toxicity and/or efficacy. OUTLINE: This is a dose-escalation study. Patients receive buparlisib orally (PO) once daily (QD) on days 1-21, gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, and cisplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.

Conditions

• Adult Solid Neoplasm
• Recurrent Non-Small Cell Lung Carcinoma
• Stage IIIA Non-Small Cell Lung Cancer
• Stage IIIB Non-Small Cell Lung Cancer
• Stage IV Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Buparlisib	Given PO
DRUG	Cisplatin	Given IV
DRUG	Gemcitabine Hydrochloride	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-08-01
• First posted: 2013-10-29
• Last updated: 2023-04-27

Locations

1 site across 1 country: United States