RecruitingPhase 2NCT04055649

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

Phase II Study of ONC201 Plus Weekly Paclitaxel in Patients With Platinum-Resistant Refractory or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer


Sponsor

Ira Winer

Enrollment

62 participants

Start Date

Jan 21, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a combination of ONC201 (a new investigational drug that targets specific proteins in cancer cells) plus weekly paclitaxel (a standard chemotherapy) for women with ovarian, fallopian tube, or peritoneal cancer that has stopped responding to platinum-based chemotherapy — called platinum-resistant or platinum-refractory disease. **You may be eligible if...** - You have ovarian, fallopian tube, or primary peritoneal cancer - Your cancer progressed within 6 months of completing platinum-based chemotherapy, or during platinum treatment - You have received no more than 4 prior treatment regimens in the platinum-resistant setting (up to 7 total) - You have at least one measurable tumor on imaging - You are in adequate general health **You may NOT be eligible if...** - Your cancer is platinum-sensitive (responded well and remained controlled for more than 6 months after platinum) - You have had more prior lines of therapy than allowed - You have severe neuropathy (nerve damage) - You are pregnant or breastfeeding - You have active uncontrolled infections or severe organ problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAkt/ERK Inhibitor ONC201

Given orally (PO)

DRUGPaclitaxel

Given IV

OTHERQuestionnaire Administration

Ancillary studies


Locations(2)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Karmanos Cancer Institute at McLaren Flint

Flint, Michigan, United States

View Full Details on ClinicalTrials.gov

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NCT04055649


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