Persevere GP-2250 1001

Clinical Trial Title A Trial to Evaluate Safety, Tolerability, and Preliminary Efficacy of Misetionamide (GP-2250) as Monotherapy or in Combination With Gemcitabine (MIROC-1)
National Clinical Trial Number: NCT03854110

Clinical Trial Protocol Description:

The purpose of this study is to research or test the safety and efficacy of a new cancer drug called misetionamide (GP-2250) in patients with ovarian cancer who have already been treated with a maximum of 2 previous platinum-based treatments and whose disease is now progressing (getting worse). GP-2250 is investigational. “Investigational” means that the drug is not approved by the U.S. Food and Drug Administration (FDA) and it must be tested to see if it is a safe and effective treatment method for the disease or condition being studied.

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following criteria:

  • Are > 18 years of age at the time of trial entry.
  • Have pathologically proven platinum-resistant epithelial ovarian, fallopian, or primary peritoneal cancer, with high-grade serous ovarian carcinoma (HGSOC) or a predominantly serous/endometroid component. Platinum-resistant disease, defined as disease progression within 6 months of last dose of platinum-based chemotherapy.
  • Have had a maximum of 2 prior regimens for platinum-resistant disease. Subjects who are positive for high FR alpha (defined per the FDA approved companion diagnostic test (ELAHERE prescribing information) must have received MIRV. Candidates for MIRV with contraindications or documented intolerance are eligible pending documentation of discussion with the Medical Monitor.
  • Have an ECOG performance status of 0-1.

You will be excluded from the study if any of the following criteria apply to you:

  • Have a diagnosis of any active malignancy other than platinum-resistant ovarian cancer within the past 2 years (not including non-melanoma skin carcinoma, ductal carcinoma in situ of the breast, or carcinoma in situ of uterine cervix treated with curative intent).
  • Have primary refractory disease (defined as failure to achieve at least a partial response (PR) to their initial platinum-based chemotherapy).
  • Have had radiotherapy (RT) to target lesions, chemotherapy, or other systemic anti-cancer therapy, including prior anti-angiogenic treatment (e.g. bevacizumab) within 4 weeks prior to starting treatment.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.

Study Details

Clinical Trial Investigator

Amina Ahmed, MD

Contact Information

Rush Cancer Center Clinical Trials Office
Clinical Trial Location
Rush University Medical Center

Contact Information

Rush Cancer Center Clinical Trials Office

Location

Rush University Medical Center

1620 W Harrison St
Chicago, IL 60612

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