drugset / Trial / NCT03485729

ONC201 in Recurrent or Metastatic Type II Endometrial Cancer Endometrial Cancer

NCT03485729

Phase 2 Terminated 27 enrolled Jazz Pharmaceuticals Oncoceutics, Inc. · collab
Non-randomizedParallel-groupOpen-labelTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Dordaviprone Small molecule 625 mg Oral

Indications