drugset / Trial / NCT02550743
BrUOG 302:BYL719, Capecitabine and Radiation for Rectal Cancer: A Brown University Oncology Research Group Study
Phase 1
Terminated
7 enrolled
Howard Safran
Brown University · collabLifespan · collabNovartis Pharmaceuticals Corporation (Financial supporter) · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
The primary goal of this Brown University Oncology Research Group is to determine that a safe dose of BYL719 can be administered with capecitabine and radiation in patients with rectal cancer. Therefore, the threshold of success for this phase I study is to establish safety.
Timeline
- Start
- 2016-06-03
- Primary completion
- 2018-11-16
- Completion
- 2018-11-16
Outcome
Outcome not reported
Stopped: “lack of accural”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alpelisib | Small molecule | 150 mg | — |
| Subject | Alpelisib | Small molecule | 200 mg | — |
| Subject | Alpelisib | Small molecule | 250 mg | — |
| Subject | Alpelisib | Small molecule | 300 mg | — |
| Background | Capecitabine | Small molecule | — | — |