Study on ONC201 and Weekly Paclitaxel for Patients with Ovarian Cancer Resistant to Platinum Treatment

Sponsor: Ira Winer

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04055649

Provider View

This clinical trial is testing the combination of ONC201 and paclitaxel to see if it can help treat ovarian, fallopian tube, or primary peritoneal cancer that has not responded to platinum-based treatments or has returned after treatment.

Patient Parameters

Program Overview

This study is exploring the effects of combining ONC201, a new type of drug that targets specific cancer cell receptors, with paclitaxel, a chemotherapy drug. The goal is to see if this combination can better treat ovarian, fallopian tube, or primary peritoneal cancer that is resistant to platinum-based treatments or has come back after treatment. ONC201 works by targeting cancer cells, while paclitaxel stops cancer cells from growing and spreading. Researchers hope that using both drugs together will be more effective than using paclitaxel alone.

Description

The main goals of this study are to determine how safe and tolerable the combination of ONC201 and paclitaxel is for patients with ovarian, fallopian tube, or primary peritoneal cancer that is resistant to platinum treatments. Researchers will also look at how well the treatment works in shrinking tumors and preventing cancer from getting worse.

Secondary goals include understanding how long the treatment effects last, how patients tolerate the treatment, and how it affects specific cancer markers in the blood. The study will also explore how the treatment interacts with the body and its potential impact on overall survival.

Participants will take ONC201 by mouth on specific days and receive paclitaxel through an IV on other days, with treatment cycles repeating every 28 days. If paclitaxel needs to be stopped, patients may continue with ONC201 alone. After finishing the treatment, patients will be monitored for one year.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with ovarian, fallopian tube, or primary peritoneal cancer.
  • Cancer has returned or not responded to platinum-based treatments.
  • No more than 4 previous treatments for platinum-resistant cancer and a total of 7 treatments overall.
  • At least one tumor that can be measured by scans.
  • Available tissue sample for some patients.
  • Completed any previous radiation therapy at least 7 days before starting the study.
  • Good overall health with a performance status score of 0 or 1.
  • Women must not be pregnant, must agree to use contraception, and have a negative pregnancy test before starting the study.
  • Adequate blood cell counts and organ function as determined by specific tests.

Exclusion Criteria

  • Recent use of other study drugs or major surgery within specified timeframes.
  • Cannot take other cancer treatments while on the study.
  • Significant side effects from previous treatments unless controlled.
  • Cannot swallow pills or have certain feeding tubes.
  • Active brain cancer unless stable and treated.
  • Use of certain medications that affect the study drugs.
  • Allergies to study drugs.
  • Pregnant or breastfeeding.
  • Serious infections or other medical conditions that could interfere with the study.
  • Other active cancers requiring treatment.
  • Conditions that prevent following the study protocol.

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