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NCT04055649 · ClinicalTrials.gov record · last posted 2026-06-17

ONC201 Plus Weekly Paclitaxel in Patients With Platinum Refractory or Resistant Ovarian Cancer

StatusRecruiting
PhasePhase 2
SponsorIra Winer
Started2020-01-21
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Amendment record 6 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 6 times since 2019-08-12; most recent amendment 2026-06-15. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2021-06-24
Status change Not Yet Recruiting→Recruitingv1
Trial Details
NCT Number NCT04055649
Lead Sponsor Ira Winer
Conditions Malignant Ovarian Epithelial Tumor, Platinum-Resistant Fallopian Tube Carcinoma, Platinum-Resistant Ovarian Carcinoma, Platinum-Resistant Primary Peritoneal Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma, Refractory Fallopian Tube Carcinoma +2 more
Enrollment 62 participants
Start Date 2020-01-21
Primary Completion 2027-05-28 (estimated)
Study Completion 2027-05-28 (estimated)
Updated on ClinicalTrials.gov 2026-06-17