Solid Tumors Clinical Trial
Official title:
A Phase Ib, Open-label Study of Alpelisib (BYL719) in Combination With Cisplatin in Patients With HPV+ Solid Tumor Malignancies
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.
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.
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