Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below
  • Phase II Study of ONC201 Plus Weekly Paclitaxel in Patients with Platinum-Resistant Refractory or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

    Cancer Categories
    • Gynecologic
    Karmanos Trial ID
    • 2018-126
    NCT ID
    • NCT04055649
    Age Group
    • Adult
    Scope
    • Local
    PhaseClick for Clinical Trial Phase DefinitionPhase II
    Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks.
    • Phase II
    Principal Investigator
    • Ira
      Winer, M.D., Ph.D., FACOG

      Oncology - Gynecologic, Oncology - Surgical View Profile

    Objective:

    Primary Objectives:

    Part 1
    • To evaluate the safety and tolerability of the combination of ONC201 and paclitaxel in patients with platinum refractory or resistant epithelial ovarian, fallopian tube or primary peritoneal cancer
    Part 2
    • To evaluate the objective response rate (ORR) of ONC201 in combination with paclitaxel in patients with platinum refractory or resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer
    • To evaluate PFS of ONC201 in combination with weekly paclitaxel in patients with platinum refractory or resistant epithelial ovarian, fallopian tube or primary peritoneal cancer
    Secondary Objectives: (In patients with platinum refractory or resistant epithelial ovarian, fallopian tube or primary peritoneal cancer)
    • To evaluate the durability/duration of response (DOR) of ONC201 in combination with paclitaxel
    • In Part 2; To evaluate the safety and patient reported tolerability of ONC201 in combination with paclitaxel
    • To evaluate the disease control rate (DCR) of ONC201 in combination with paclitaxel
    • To evaluate the Cancer Antigen-125 (CA-125) and/or Human Epididymis Factor 4 (HE-4) response of ONC201 in combination with paclitaxel in those patients with one or both of these tumor markers upregulated
    • To characterize the PK and PD of ONC201 in combination with paclitaxel
    • To obtain preliminary estimates of overall survival (OS) of ONC201 in combination with weekly paclitaxel
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
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    Phone: 800-527-6266

    Karmanos Cancer Institute at Lawrence and Idell Weisberg Cancer Treatment Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
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    Phone: 800-527-6266