ONC201 in Recurrent or Metastatic Type II Endometrial Cancer Endometrial Cancer
Summary
This was a Phase 2, Simon two-stage, non-randomized, open-label, 2-arm trial of dordaviprone (ONC201) in women with metastatic or recurrent Type II endometrial cancer who failed at least 1 prior chemotherapy regimen. Patients with histologically confirmed Type II endometrial cancer, including but not limited to serous, clear cell, carcinosarcoma, adenosquamous, and mixed histologies were eligible. The primary objective of this study was to determine the efficacy of dordaviprone (ONC201) in metastatic type II endometrial cancer. Note: This study was completed by predecessor company, Oncoceutics, Inc.
Timeline
- Start
- 2018-03-21
- Primary completion
- 2023-01-19
- Completion
- 2023-01-19
Outcome
Outcome not reported
Stopped: “This study was terminated due to a change in the Sponsor's corporate priorities. The decision to terminate the study was not based on any safety concerns.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dordaviprone | Small molecule | 625 mg | Oral |