Phase II Study of Oral ONC201 Combined With Weekly Intravenous Paclitaxel for Women With Platinum-Resistant or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

What this Trial Is About

Researchers are studying the combination of ONC201 and paclitaxel in women with platinum-resistant or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. This phase II trial aims to assess the safety, tolerability, and effectiveness of this drug combination compared to paclitaxel alone. ONC201 works by targeting specific receptors on cancer cells to promote their destruction, while paclitaxel interferes with cancer cell growth and division. Participants receive ONC201 orally on days 1, 8, 15, and 22 and paclitaxel intravenously over one hour on days 2, 9, and 16, repeating every 28 days as long as the cancer does not progress and side effects are manageable. If paclitaxel must be stopped, patients may continue treatment with ONC201 alone. After completing the treatment cycles, participants are followed for one year. During the study, patients undergo safety assessments, tumor response evaluations, and monitoring of progression-free survival and overall survival for up to one year. Other measurements include cancer marker responses, pharmacokinetics, pharmacodynamics, and immune response studies. Patient-reported symptoms and adverse events are also tracked to evaluate tolerability throughout the trial.

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