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NCT03485729 · ClinicalTrials.gov registry record · Phase 2
ONC201 in Recurrent or Metastatic Type II Endometrial Cancer Endometrial Cancer
A Phase 2 study, sponsored by Jazz Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
NCT03485729: Clinical Trial Phase 2 study, sponsored by Jazz Pharmaceuticals.
NCT03485729 is a Phase 2 study that was terminated before completion, run by Jazz Pharmaceuticals. The registered enrollment target is 27 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03485729, a Phase 2 study, was terminated before completion, sponsored by Jazz Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
Study 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.
Primary Outcome
Progression-free survival rate at 2 months was defined as the percentage of participants who exhibited progression-free survival for \>8 weeks (\>56 days) following treatment initiation; only Arm B participants were analyzed for this outcome.
Interventions
- DRUG Dordaviprone (ONC201)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2018-03-21 |
| Est. Completion | 2023-01-19 |
| Phase | Phase 2 |
Why NCT03485729 stopped before completion
NCT03485729 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Dordaviprone (ONC201) is the first listed.
NCT03485729 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03485729 about?
NCT03485729 is a clinical study titled "ONC201 in Recurrent or Metastatic Type II Endometrial Cancer Endometrial Cancer". 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 no...
What is the current status of trial NCT03485729?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2018-03-21. Estimated completion is 2023-01-19.
What interventions are being tested in trial NCT03485729?
The interventions under investigation include: Dordaviprone (ONC201) (DRUG).
Who is sponsoring clinical trial NCT03485729?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03485729's enrollment target sits among peer trials
27 1697th of 2000 higher than 293 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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