RecruitingNCT03877796

Clinical Pre-screening Protocol for Ovarian Cancer

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


Sponsor

Allarity Therapeutics

Enrollment

60 participants

Start Date

Apr 11, 2019

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria4

  • 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 Criteria2

  • 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

Interventions

DEVICEDrug Response Predictor® (DRP)

A DRP is an assay that based on samples from a tumor can predict whether the tumor will respond to a specific drug or not.


Locations(5)

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Swedish Center for Research and Innovation

Seattle, Washington, United States

Beatson West of Scotland Cancer Centre

Glasgow, Scotland, United Kingdom

Guy's and St Thomas' NHS Foundation Trust, Guy's Hospital

London, United Kingdom

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NCT03877796


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