Actively Recruiting
Phase II Study of ONC201 Plus Weekly Paclitaxel in Patients With Platinum-Resistant Refractory or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Led by Ira Winer · Updated on 2025-06-18
62
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the combination of ONC201 and paclitaxel in women with platinum-resistant or refractory epithelial ovarian, fallopian tube, or primary peritoneal cancer. This phase II trial aims to evaluate the safety, side effects, and how well this drug combination works compared to paclitaxel alone. ONC201 works by targeting specific cell receptors on cancer cells to destroy them, while paclitaxel interferes with cancer cell growth and spread. Participants receive ONC201 by mouth on days 1, 8, 15, and 22, and paclitaxel is given intravenously over one hour on days 2, 9, and 16. Each treatment cycle lasts 28 days and repeats if the cancer does not worsen or side effects are manageable. If paclitaxel must be stopped, patients may continue taking ONC201 alone. After finishing treatment, patients are followed for one year. During the study, patients undergo regular evaluations including tumor measurements, blood tests for cancer markers CA-125 and HE-4, and assessments of side effects and symptoms. Researchers also monitor the immune response and drug levels in the body. The main outcomes include treatment safety, tumor response, progression-free survival, and overall survival, with follow-up lasting up to one year after treatment begins.
CONDITIONS
Brief Title
ONC201 Plus Weekly Paclitaxel in Patients With Platinum Refractory or Resistant Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer.
- Disease progression within 6 months after completing at least one platinum-containing treatment cycle or refractory disease.
- No more than 4 prior treatment regimens in the platinum-resistant setting and no more than 7 total prior regimens.
- At least one measurable tumor lesion as per RECIST v1.1.
- Availability of tumor tissue for pharmacokinetic/pharmacodynamic studies, with biopsy if no archival tissue exists.
- Completed any prior palliative radiation at least 7 days before starting study treatment and recovered from side effects.
- ECOG performance status of 0 or 1.
- Female patients not of childbearing potential or fertile patients agreeing to use contraception and with a negative pregnancy test before treatment.
- Adequate bone marrow, renal, and liver function as defined by specific laboratory values.
You will not qualify if you...
- Use of other study drugs within 21 days or 5 half-lives before starting treatment.
- Major surgery within 21 days or minor surgery within 7 days before treatment start.
- Receiving other chemotherapy, immunotherapy, hormonal therapy, or biological therapy during the study (except palliative radiation).
- Grade greater than 1 toxicity from prior therapy unless controlled.
- Inability to swallow oral medication or use of feeding tubes.
- Known active brain metastases or untreated central nervous system disease.
- Use of drugs or products affecting CYP3A4 that cannot be stopped before and during the study.
- Known allergy or contraindication to study treatments.
- Pregnant or breastfeeding.
- Serious active infections or other medical conditions that impair treatment ability.
- Presence of other active cancers requiring treatment except certain non-invasive or monitored cancers.
- Psychological, social, or geographic factors preventing compliance with the study protocol.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or unacceptable toxicity
Participants receive the study drugs ONC201 orally on days 1, 8, 15, and 22, and paclitaxel intravenously over 1 hour on days 2, 9, and 16. Treatment cycles repeat every 28 days unless there is disease progression or unacceptable side effects. Participants may continue ONC201 alone if paclitaxel is stopped.
Weekly visits for each 28-day cycle
Duration - Up to 1 year
After completing study treatment, participants are followed for safety, disease progression, and survival for 1 year.
Periodic visits during the 1-year follow-up
Trial Site Locations
Total: 2 locations
1
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
2
Karmanos Cancer Institute at McLaren Flint
Flint, Michigan, United States, 48532
Actively Recruiting
Research Team
I
Ira Winer, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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