Clinical Trial 24097-A

• Overview

  Study Title:

  Development of Drug Response Predictor (DRP) to Test Sensitivity to Investigational Anti-Cancer Drugs in Patients With Advanced Ovarian Cancer

  Summary:

  The patient's local archival tumor tissue (FFPE) from original tumor, or from the metastatic tissue, will be collected to potentially identify if they - at a later stage of their disease - will be likely to benefit from treatment with any of the investigational cancer drugs available to Allarity Therapeutics. Data from this study can further be used to explore in a retrospective fashion, sensitivity to other chemotherapeutic drugs previously used in the treatment of their ovarian cancer, to investigate whether or not the DRP® method can predict and confirm the obtained sensitivity to the prior given drugs as well as prospective analyses guiding the Investigators on future treatments.

  Objective:

  Primary Objective To identify ovarian cancer patients with high likelihood of being sensitive to investigational cancer drugs, based on DRP® pre-screening of archival formalin-fixed paraffin-embedded (FFPE) ovarian cancer tumor tissue from the time of diagnosis and/or the most recent re-biopsy, if available. Secondary Objectives Possibility to use the DRP® to do a retrospective analysis of whether or not the DRP® method can predict and confirm the obtained sensitivity to the prior given drugs used in the treatment of ovarian cancer as well as prospective analyses guiding the Investigators on future treatments.

• Inclusion Criteria

  Key Inclusion Criteria:
  • Patients with histological confirmed epithelia ovarian cancer.
  • Patients must have platinum-resistant disease, defined as progression within >1 to > Patients have received no more than three prior treatment regimens in the platinum resistant, platinum refractory, or platinum ineligible setting.
  • FFPE tumor tissue available from the current relapse, if obtainable, otherwise the most recent archival tumor tissue

• Exclusion Criteria

  Key Exclusion Criteria:
  • Other malignancy, unless patients' natural history or treatment does not have the potential to interfere with safety or efficacy assessments of future clinical trials, in the opinion of the Investigator.
  • Evidence of any other disease or psychological dysfunction giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect patients understanding of the information, compliance with study routines, or place the patient at high risk from treatment-related complications

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.