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ONC201 Plus Weekly Paclitaxel for Platinum-Resistant Ovarian Cancer

This study is testing a combination of two drugs, ONC201 and paclitaxel, for women with ovarian, fallopian tube, or primary peritoneal cancer that has returned or isn't responding to platinum-based chemotherapy. ONC201 is a new type of drug that targets specific receptors on cancer cells to destroy them. Paclitaxel is a chemotherapy drug that works to stop cancer cell growth. The study aims to see how safe and effective this combination is. We will be looking at side effects and how many patients respond to the treatment. You may be eligible if you are 18 or older and have a diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer that has progressed within 6 months of your last platinum-containing treatment.

Study design
This is an interventional study with a planned enrollment of 62 participants. It is evaluating the safety and effectiveness of ONC201 and paclitaxel.
What's involved
You would receive ONC201 orally and paclitaxel intravenously. There will also be questionnaire administration for ancillary studies.
Compensation
Not stated in the trial record.
Follow-up
The study will measure treatment-related adverse events and dose-limiting toxicities for up to 28 days. Objective response rate will be measured for up to 1 year.

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NCT04055649

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Ira Winer
~62 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:Akt/ERK Inhibitor ONC201PaclitaxelQuestionnaire Administration

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of treatment related adverse events (AEs) (Part 1)
Measured over Up to 28 days
+3 more outcomes measured

Conditions

Malignant Ovarian Epithelial Tumor
Platinum-Resistant Fallopian Tube Carcinoma
Platinum-Resistant Ovarian Carcinoma
Platinum-Resistant Primary Peritoneal Carcinoma
Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal Carcinoma
Refractory Fallopian Tube Carcinoma
Refractory Ovarian Carcinoma
Refractory Primary Peritoneal Carcinoma

Explore related trials

Fallopian Tube CarcinomaMalignant Ovarian NeoplasmPrimary Peritoneal Cancer

Where it's being run

2 sites across 1 states
Michigan2

Study leadership

  • Ira Winer, M.D. · PRINCIPAL_INVESTIGATOR · Barbara Ann Karmanos Institute

Who to contact

Ira Winer, M.D.
[email protected]
(313) 576-9435
Email the study team

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Eligibility criteria

Inclusion

Histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Progressed within 6 months of completing at least 1 cycle of last platinum containing regimen. Patients with refractory disease (progression during platinum-containing therapy) are eligible. This includes both adjuvant therapy and in the recurrent setting.
No more than 4 prior treatment regimens defined as investigational, chemotherapy, hormonal, biologic, or targeted therapy in the platinum resistant setting and total of 7 prior regimens in all settings will be allowed. Prior maintenance therapy with biologic or targeted agent does NOT count as a treatment regimen (e.g. Maintenance bevacizumab, Parpi, or immunotherapy).
At least one measurable lesion according to RECIST v1.1.
For the eight patients enrolled for PK/PD. Availability of tissue from carcinoma. For most patients this will be archival tissue. If there is no archival tissue available, biopsy of lesion MUST be performed prior to initiation of therapy. Lesions must be available for biopsy as well in these patients.
Any prior palliative radiation therapy must be completed at least 7 days prior to start of study treatment and patients must have recovered from any acute adverse effects prior to start of study treatment.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1.
Female patients who are not of childbearing potential and fertile female patients of childbearing potential who agree to use adequate contraceptive measures from 2 weeks prior to the study and until 1 month after study treatment discontinuation, who are not breastfeeding, and who have a negative serum or urine pregnancy test within 3 days prior to start of study treatment.
Patients must have adequate (at baseline):
Presence of other active cancers other than ovarian cancer except those that do not require active therapy (i.e. on surveillance) and known non-invasive cancers and in situ cancers (e.g. non-melanoma skin cancers).
Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.

Exclusion

Use of a study drug (approved or investigational drug therapy) ≤21 days or 5 half-lives (whichever is shorter) prior to the first dose of study treatment. For study drugs for which 5 half-lives is ≤21 days, a minimum of 10 days between termination of the study drug and administration of current study treatment is required.
Major surgical procedures ≤21 days of beginning study treatment, or minor surgical procedures ≤7 days. No waiting required following port-a-cath placement, ureteral stent placement, percutaneous nephrostomy tube placement.
No other (chemotherapy, immunotherapy, hormonal anti-cancer therapy, radiotherapy \[except for palliative local radiotherapy\]), biological therapy or other novel agent is to be permitted while the patient is receiving study medications
Grade \>1 toxicity from prior therapy (except alopecia or anorexia or above hematologic criteria) unless controlled by medications.
Inability to swallow oral medication. Note: Patient may not have a percutaneous endoscopic gastrostomy (PEG) tube or be receiving total parenteral nutrition (TPN) on this trial.
Known malignant central nervous system disease other than neurologically stable, treated brain metastases - defined as metastasis having no evidence of progression after treatment for at least 4 weeks (including brain radiotherapy). Must be off any systemic corticosteroids for the treatment of brain metastases for at least 14 days prior to enrollment.
Patient has had prescription or non-prescription drugs or other products (i.e. grapefruit juice) known to be moderate to strong inhibitors or inducers of CYP3A4, which cannot be discontinued 1 week prior to Day 1 of dosing and withheld throughout the study until 1 weeks after the last dose of study drug.
Any known hypersensitivity or contraindication to the components of study treatment
Pregnant or lactating

What this trial measures

  • Incidence of treatment related adverse events (AEs) (Part 1)Up to 28 days

    Graded according to National Cancer Institute (NCI) Common Terminology Criteria in Adverse Events (CTCAE) version (v)5.0.

  • Incidence of dose limiting toxicities (DLT's) (Part 1)Up to 28 days

    Graded according to NCI CTCAE v5.0.

  • Objective response rate (ORR) (Part 2)Up to 1 year

    Defined as the proportion of patients achieving a complete (CR) or partial tumor response (PR) by computed tomography (CT) evaluation according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Will be calculated as the proportion of patients achieving a complete or partial tumor response according to RECIST v1.1 criteria and its associated 1-sided 92% confidence interval (CI) will be also estimated using Pearson-Klopper's exact method.

  • Progression free survival (PFS) (Part 2)From study treatment initiation to objective tumor progression or death, assessed up to 1 year

    Will be summarized using Kaplan-Meier (KM) curves and their median and confidence intervals (CI's) will be further estimated.