Clinical Pre-screening Protocol for Ovarian Cancer

October 28, 2025 updated by: Allarity Therapeutics

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Active, not recruiting
        • Guy's and St Thomas' NHS Foundation Trust, Guy's Hospital
    • Scotland
      • Glasgow, Scotland, United Kingdom, G12 0YN
        • Active, not recruiting
        • Beatson West of Scotland Cancer Centre
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Completed
        • Dana-Farber Cancer Institute
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • OU Health Stephenson Cancer Center
        • Principal Investigator:
          • Kathleen Moore, MD
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Swedish Center for Research and Innovation
        • Contact:
        • Principal Investigator:
          • Fernanda Baptista Musa, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients will be identified at their already planned treatment and or at control visits at the oncology department

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ovarian cancer patients
with formalin-fixed paraffin-embedded (FFPE) tumor tissue available
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allarity Therapeutics

Collaborators

Amarex Clinical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2019

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 14, 2019

First Submitted That Met QC Criteria

March 14, 2019

First Posted (Actual)

March 18, 2019

Study Record Updates

Last Update Posted (Estimated)

October 30, 2025

Last Update Submitted That Met QC Criteria

October 28, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2X-1000

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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