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NCT04055649 · ClinicalTrials.gov registry record · Phase 2
ONC201 Plus Weekly Paclitaxel in Patients With Platinum Refractory or Resistant Ovarian Cancer
A Phase 2 study of Recurrent Ovarian Carcinoma and Recurrent Fallopian Tube Carcinoma, sponsored by Ira Winer.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 62
- Enrollment target
- 2
- Study locations
NCT04055649: Recruiting Phase 2 study of Recurrent Ovarian Carcinoma and Recurrent Fallopian Tube Carcinoma, sponsored by Ira Winer.
NCT04055649 is a Phase 2 study of Recurrent Ovarian Carcinoma and Recurrent Fallopian Tube Carcinoma that is actively recruiting participants, run by Ira Winer. The registered enrollment target is 62 participants, below the 123-participant average among 39 other Recurrent Ovarian Carcinoma trials with a reported enrollment target (50% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04055649, a Phase 2 study of Recurrent Ovarian Carcinoma and Recurrent Fallopian Tube Carcinoma, is actively recruiting participants, sponsored by Ira Winer.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 62 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase II trial studies the side effects of ONC201 and paclitaxel and how well they work in treating patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer that has come back (recurrent), or that does not respond to treatment (refractory). ONC201 is the first in its class of drugs that antagonize some specific cell receptors on cancer cells, leading to their destruction. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ONC201 and paclitaxel may work better in treating patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer compared to paclitaxel alone.
Primary Outcome
Graded according to National Cancer Institute (NCI) Common Terminology Criteria in Adverse Events (CTCAE) version (v)5.0.
Conditions Studied
Interventions
- DRUG Paclitaxel
- OTHER Questionnaire Administration
- DRUG Akt/ERK Inhibitor ONC201
Study Locations (2)
Michigan
- Barbara Ann Karmanos Cancer Institute - Detroit
- Karmanos Cancer Institute at McLaren Flint - Flint
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2020-01-21 |
| Est. Completion | 2027-05-28 |
| Phase | Phase 2 |
What NCT04055649 shows while recruiting
NCT04055649 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 123-participant average among 39 other Recurrent Ovarian Carcinoma trials with a reported enrollment target (50% lower).
The record links to 10 conditions, with Recurrent Ovarian Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Paclitaxel is the first listed.
NCT04055649 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT04055649 about?
NCT04055649 is a clinical study titled "ONC201 Plus Weekly Paclitaxel in Patients With Platinum Refractory or Resistant Ovarian Cancer". This phase II trial studies the side effects of ONC201 and paclitaxel and how well they work in treating patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer that has come back (recurrent), or that does not respond to treatment (refractory). ONC201 is the...
What is the current status of trial NCT04055649?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2020-01-21. Estimated completion is 2027-05-28.
What conditions does trial NCT04055649 study?
This clinical trial studies the following conditions: Recurrent Ovarian Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Primary Peritoneal Carcinoma, Platinum-Resistant Ovarian Carcinoma, Platinum-Resistant Fallopian Tube Carcinoma.
What interventions are being tested in trial NCT04055649?
The interventions under investigation include: Paclitaxel (DRUG), Questionnaire Administration (OTHER), Akt/ERK Inhibitor ONC201 (DRUG).
Who is sponsoring clinical trial NCT04055649?
This trial is sponsored by Ira Winer, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04055649 being conducted?
This trial has 2 study locations across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Ovarian Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04055649's enrollment target sits among peer trials
62 16th of 39 higher than 23 of 39 other Recurrent Ovarian Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Ovarian Carcinoma 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.
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