drugset / Trial / NCT03448718
Trial of Olaparib in Patients With Metastatic Urothelial Cancer Harboring DNA Damage Response Gene Alterations
Phase 2
Completed
19 enrolled
Matthew Galsky
AstraZeneca · collabIcahn School of Medicine at Mount Sinai · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a single arm open label multi-institutional phase II trial of olaparib monotherapy in subjects with metastatic urothelial cancer harboring somatic DNA damage response (DDR) alterations. The primary objective of the study is to estimate the objective response rate (per RECIST 1.1) to treatment with olaparib.
Timeline
- Start
- 2018-04-17
- Primary completion
- 2021-07-14
- Completion
- 2021-10-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olaparib | Small molecule | 200 mg | — |
| Subject | Olaparib | Small molecule | 300 mg | — |