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

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Ira Winer
Study ID
NCT04055649
Phase
PHASE2
Status
Recruiting
Apply to this trial

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Akt/ERK Inhibitor ONC201 — DRUG
    Given orally (PO)
  • Paclitaxel — DRUG
    Given IV
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Jan 21, 2020
Status verified
Jun 2026
Primary completion
May 28, 2027
Completion
May 28, 2027

Study Design

Enrollment
62 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment - ONC201 & Paclitaxel
    Patients receive ONC201 PO on days 1, 8, 15, and 22 and paclitaxel IV over 1 hour on days 2, 9, and 16. Cycles repeat every 28 days in the absence disease progression or unacceptable toxicity. If paclitaxel must be stopped for any reason, patients may continue on ONC201 alone.

Primary Outcome Measure

Incidence of treatment related adverse events (AEs) (Part 1) [ Time Frame: Up to 28 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Barbara Ann Karmanos Cancer InstituteDetroitMichigan48201
Clinical Trials Office
(800) 527-6266
Robert Morris, M.D. (SUB_INVESTIGATOR)
Ira Winer, M.D. (PRINCIPAL_INVESTIGATOR)
Radhika Gogoi, M.D. (SUB_INVESTIGATOR)
Karmanos Cancer Institute at McLaren FlintFlintMichigan48532
John J Wallbillich, M.D.
[email protected]

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By research site
Barbara Ann Karmanos Cancer Institute· Detroit, MIKarmanos Cancer Institute at McLaren Flint· Flint, MI

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