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Clinical Pre-screening Protocol for Ovarian Cancer

NCT03877796 · Allarity Therapeutics
In plain English

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Official title
Development of Drug Response Predictor (DRP) to Test Sensitivity to Investigational Anti-Cancer Drugs in Patients With Advanced Ovarian Cancer
About this study
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.
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
Study design
Enrollment target: 60 participants
Age groups: adult, older_adult
Timeline
Starts: 2019-04-11
Estimated completion: 2026-12
Last updated: 2025-10-30
Interventions
Device: Drug Response Predictor® (DRP)
Primary outcomes
  • Identification of ovarian cancer patients with high likelihood of being sensitive to investigational cancer drug (up to 2 years)
Sponsor
Allarity Therapeutics · industry
With: Amarex Clinical Research
Contacts & investigators
ContactUS: Kathleen Moore · contact · KathleenMoore@ouhealth.com · +1 405-271-8707
ContactEurope: Rebecca Kristeleit · contact · Rebecca.Kristeleit@gstt.nhs.uk
All locations (5)
Dana-Farber Cancer InstituteCompleted
Boston, Massachusetts, United States
OU Health Stephenson Cancer CenterRecruiting
Oklahoma City, Oklahoma, United States
Swedish Center for Research and InnovationRecruiting
Seattle, Washington, United States
Beatson West of Scotland Cancer CentreActive Not Recruiting
Glasgow, Scotland, United Kingdom
Guy's and St Thomas' NHS Foundation Trust, Guy's HospitalActive Not Recruiting
London, United Kingdom
Clinical Pre-screening Protocol for Ovarian Cancer · TrialPath