drugset / Trial / NCT02620839
Phase Ib Study of Alpelisib With Cisplatin in Patients With HPV+ Solid Tumor Malignancies
Non-randomizedFactorialOpen-labelTreatment
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.
Timeline
- Start
- 2016-12-01
- Primary completion
- 2019-01-28
- Completion
- 2019-01-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alpelisib | Small molecule | 200 mg | Oral |
| Subject | Alpelisib | Small molecule | 250 mg | Oral |
| Subject | Alpelisib | Small molecule | 300 mg | Oral |
| Subject | Alpelisib | Small molecule | 350 mg | Oral |
| Subject | Cisplatin | Other / unclassified | 30 mg/m2 | Intravenous |
| Subject | Cisplatin | Other / unclassified | 35 mg/m2 | Intravenous |