Clinical Pre-screening Protocol for Ovarian Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Drug Response Predictor® (DRP).
- Who it may be relevant to
- Registry conditions: Ovarian Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Development of Drug Response Predictor (DRP) to Test Sensitivity to Investigational Anti-Cancer Drugs in Patients With Advanced Ovarian Cancer
Overview
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.
Interventions
- Device Drug 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.
Primary outcome measures
- Identification of ovarian cancer patients with high likelihood of being sensitive to investigational cancer drug [Time frame: up to 2 years]
Secondary outcome measures (1)
- 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 [Time frame: up to 2 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 7 centers
- Moffitt Cancer Center — Tampa
- Emory Winship Cancer Institute — Atlanta
- University of New Mexico Comprehensive Cancer — Albuquerque
- The Blavatnik Family-Chelsea Medical Center at Mount Sinai — New York
- OU Health Stephenson Cancer Center — Oklahoma City
- University Medical Center Cancer Center — Lubbock
- Swedish Center for Research and Innovation — Seattle
United Kingdom · 2 centers
- Beatson West of Scotland Cancer Centre — Glasgow
- Guy's and St Thomas' NHS Foundation Trust, Guy's Hospital — London
Identifiers
NCT: NCT03877796 · 2X-1000