RecruitingPhase 2

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

United States62 participantsStarted 2020-01-21

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Bone marrow function: Absolute neutrophil count (ANC) ≥1,500/µL. Platelets
. Renal function: Calculated creatinine clearance (CrCl) ≥35 mL/min/1.73 mm2
. Hepatic function: Bilirubin less than or equal to 1.5 x ULN; alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) less than or equal to 3 x ULN. AP, AST and ALT less than or equal to 5 x ULN is acceptable if patient has known hepatic metastasis

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of treatment related adverse events (AEs) (Part 1)

Timeframe: Up to 28 days

Incidence of dose limiting toxicities (DLT's) (Part 1)

Timeframe: Up to 28 days

Objective response rate (ORR) (Part 2)

Timeframe: Up to 1 year

Progression free survival (PFS) (Part 2)

Timeframe: From study treatment initiation to objective tumor progression or death, assessed up to 1 year

Trial details

NCT IDNCT04055649

SponsorIra Winer

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05-28

Contact for this trial

Ira Winer, M.D.

(313) 576-9435 iwiner@med.wayne.edu

View on ClinicalTrials.gov More Malignant Ovarian Epithelial Tumor trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Bone marrow function: Absolute neutrophil count (ANC) ≥1,500/µL. Platelets
. Renal function: Calculated creatinine clearance (CrCl) ≥35 mL/min/1.73 mm2
. Hepatic function: Bilirubin less than or equal to 1.5 x ULN; alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) less than or equal to 3 x ULN. AP, AST and ALT less than or equal to 5 x ULN is acceptable if patient has known hepatic metastasis

What they're measuring

Incidence of treatment related adverse events (AEs) (Part 1)

Timeframe: Up to 28 days

Incidence of dose limiting toxicities (DLT's) (Part 1)

Timeframe: Up to 28 days

Objective response rate (ORR) (Part 2)

Timeframe: Up to 1 year

Progression free survival (PFS) (Part 2)

Timeframe: From study treatment initiation to objective tumor progression or death, assessed up to 1 year