Pre-screening to match ovarian cancer tumor samples with investigational cancer drugs

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

Tests if analyzing archived tumor tissue with a Drug Response Predictor can show which ovarian cancer patients might benefit from certain investigational cancer drugs.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Allarity Therapeutics (industry)
• Drugs / interventions: chemotherapy
• Locations: 5 sites (Boston, Massachusetts and 4 other locations)
• Trial ID: NCT03877796 on ClinicalTrials.gov

What this trial studies

This observational pre-screening protocol collects patients' archival or metastatic FFPE tumor tissue to run the Drug Response Predictor (DRP®) developed by Allarity Therapeutics. The DRP® output is used to identify whether specimens show predicted sensitivity to investigational agents available through the sponsor and to compare predicted sensitivity with prior chemotherapy responses in retrospective analyses. Eligible participants generally have epithelial ovarian cancer that is platinum-resistant or platinum-ineligible and have available FFPE tissue; platinum-refractory patients are excluded. The program is conducted at multiple U.S. cancer centers and is intended to generate data to guide future treatment decisions and prospective testing.

Who should consider this trial

Good fit: Ideal candidates have histologically confirmed epithelial ovarian cancer that is platinum-resistant or platinum-ineligible, have available FFPE tumor tissue, and have received no more than one prior line of therapy in the platinum-resistant/ineligible setting.

Not a fit: Patients with platinum-refractory disease (progression during the last platinum-based chemotherapy), those without available FFPE tissue, or those with other active non‑cured malignancies are unlikely to benefit from this pre-screening.

Why it matters

Potential benefit: If successful, this could help identify patients more likely to respond to specific investigational drugs and guide future treatment choices.

How similar studies have performed: Similar gene-expression and in vitro drug-response predictor approaches have shown promising retrospective correlations but have limited prospective validation to date.

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

Where this trial is running

Boston, Massachusetts and 4 other locations

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (COMPLETED)
• OU Health Stephenson Cancer Center — Oklahoma City, Oklahoma, United States (RECRUITING)
• Swedish Center for Research and Innovation — Seattle, Washington, United States (RECRUITING)
• Beatson West of Scotland Cancer Centre — Glasgow, Scotland, United Kingdom (ACTIVE_NOT_RECRUITING)
• Guy's and St Thomas' NHS Foundation Trust, Guy's Hospital — London, United Kingdom (ACTIVE_NOT_RECRUITING)

Study contacts

• Study coordinator: US: Kathleen Moore

Conditions: Ovarian Cancer