NCT03485729

ONC201 in Recurrent or Metastatic Type II Endometrial Cancer Endometrial Cancer

A Phase II Study of ONC201 in Recurrent or Metastatic Type II Endometrial Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study included 3 arms: Arm A, Arm B, and Arm C. Dordaviprone (ONC201) was to be administered as a dose of 625 mg by mouth, once or twice each week until disease progression, unacceptable toxicity, or if the patient discontinued for any other reason. For Arm A and Arm B, ONC201 administration occurred on Days 1, 8, and 15 of each 3-week cycle. For Arm C, ONC201 administration occurred on Days 1, 2, 8, 9, and 15, and 16 of each 3-week cycle. All patients in Arm A had a biopsy of their tumor one day after the second dose of dordaviprone (ONC201) on Cycle 1, Day 9. All patients in Arm C had a biopsy of their tumor one day after the fourth dose of dordaviprone (ONC201) on Cycle 1, Day 10. Assessments of objective tumor response were conducted using RECIST version 1.1. Safety was assessed through the reporting of adverse events, measurement of vital signs, electrocardiograms, and clinical laboratory results. Before the study was terminated, a total of 27 patients were enrolled and received at least 1 dose of dordaviprone (ONC201): 10 patients in Arm A, 14 patients in Arm B, and 3 patients in Arm C.

Conditions

• Endometrial Cancer Recurrent

Interventions

Type	Name	Description
DRUG	Dordaviprone (ONC201)	625 mg dordaviprone (ONC201)

Timeline

• Start date: 2018-03-21
• Primary completion: 2023-01-19
• Completion: 2023-01-19
• First posted: 2018-04-02
• Last updated: 2024-12-24
• Results posted: 2024-12-24

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study