NCT02620839

Phase Ib Study of Alpelisib With Cisplatin in Patients With HPV+ Solid Tumor Malignancies

A Phase Ib, Open-label Study of Alpelisib (BYL719) in Combination With Cisplatin in Patients With HPV+ Solid Tumor Malignancies

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Pamela Munster · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase Ib trial studies the best dose and side effects of alpelisib and cisplatin in treating patients with human papillomavirus (HPV) positive solid tumor malignancies. Alpelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, 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. Giving alpelisib and cisplatin may work better in treating patients with solid tumor malignancies.

Detailed description

PRIMARY OBJECTIVES: I. To determine the maximally tolerated dose and recommended phase 2 dose of alpelisib in combination with weekly cisplatin. SECONDARY OBJECTIVES: I. To determine the objective response rate and median progression-free survival with the treatment combination in HPV positive (+) solid tumor malignancies. II. To characterize the safety profile of the combination. OUTLINE: This is a dose escalation study. Patients receive alpelisib orally (PO) once daily (QD) on days 1-14 or 1-21, and cisplatin intravenously (IV) over 1-2 hours on days 1 and 8, or days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	Alpelisib	Given PO
DRUG	Cisplatin	Given IV

Timeline

• Start date: 2016-12-01
• Primary completion: 2019-01-28
• Completion: 2019-01-28
• First posted: 2015-12-03
• Last updated: 2020-01-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study