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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04055649
The ClinicalTrials.gov registry entry for NCT04055649 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 123-participant average among 39 other Recurrent Ovarian Carcinoma trials with a reported enrollment target (50% lower). The listed sponsor is Ira Winer, which has 2 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 1 distinct geographic area - top geographies include 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.
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