Actively Recruiting
ONC201 Plus Weekly Paclitaxel in Patients With Platinum Refractory or Resistant Ovarian Cancer
Led by Ira Winer · Updated on 2025-06-18
62
Participants Needed
2
Research Sites
383 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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.
- Cancer progressed within 6 months after completing at least 1 cycle of last platinum-containing treatment, including refractory disease.
- No more than 4 prior treatment regimens in the platinum-resistant setting and no more than 7 prior regimens total.
- At least one measurable lesion as defined by RECIST v1.1.
- Availability of carcinoma tissue for 8 patients enrolled for pharmacokinetic/pharmacodynamic studies.
- Completion of any prior palliative radiation therapy at least 7 days before study and recovery from acute effects.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Female patients not of childbearing potential or fertile females agreeing to use contraception from 2 weeks before to 1 month after treatment, not breastfeeding, and with negative pregnancy test within 3 days before treatment.
- Adequate baseline bone marrow, renal, and hepatic function as specified.
You will not qualify if you...
- Use of approved or investigational study drugs within 21 days or 5 half-lives before starting study treatment.
- Major surgery within 21 days or minor surgery within 7 days before starting treatment (except certain procedures).
- Receiving other chemotherapy, immunotherapy, hormonal therapy, radiotherapy (except palliative), biological therapy, or novel agents during the study.
- Grade greater than 1 toxicity from prior therapy, except alopecia, anorexia, or specified hematologic criteria, unless controlled by medication.
- Inability to swallow oral medication or presence of PEG tube or total parenteral nutrition.
- Known malignant central nervous system disease except stable, treated brain metastases off corticosteroids for at least 14 days.
- Use of drugs or products affecting CYP3A4 that cannot be stopped 1 week before dosing and during the study.
- Known hypersensitivity or contraindication to study treatment components.
- Pregnant or breastfeeding.
- Serious active infection or other serious medical conditions that impair ability to receive treatment.
- Active cancers other than ovarian cancer requiring therapy, except non-invasive or in situ cancers.
- Psychological, familial, social, or geographical conditions preventing protocol compliance.
AI-Screening
AI-Powered Screening
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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.
CONTACT
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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