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Clinical Trials/NCT03877796
NCT03877796
Recruiting
Not Applicable

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

Allarity Therapeutics5 sites in 2 countries60 target enrollmentApril 11, 2019
ConditionsOvarian Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ovarian Cancer
Sponsor
Allarity Therapeutics
Enrollment
60
Locations
5
Primary Endpoint
Identification of ovarian cancer patients with high likelihood of being sensitive to investigational cancer drug
Status
Recruiting
Last Updated
6 months ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
April 11, 2019
End Date
December 1, 2026
Last Updated
6 months ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients with histological confirmed epithelia ovarian cancer
  • Patients must have platinum-resistant disease, defined as progression within 6 months after the last dose of platinum-based chemotherapy, or are platinum ineligible.
  • Patients have received no more than one prior line of therapy in the platinum resistant or platinum ineligible setting
  • FFPE tumor tissue available

Exclusion Criteria

  • Patients who have platinum-refractory disease, defined as progression during the last platinum-based chemotherapy.
  • Other malignancy with exception of any stage I and II cancer that is deemed cured by the Investigator

Outcomes

Primary Outcomes

Identification of ovarian cancer patients with high likelihood of being sensitive to investigational cancer drug

Time Frame: up to 2 years

based on FFPE ovarian cancer tissue

Secondary Outcomes

  • Retrospective analysis of whether or not the DRP method can predict and confirm the obtained sensitivity to the prior drugs used in the treatment of ovarian cancer(up to 2 years)

Study Sites (5)

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