Clinical Pre-screening Protocol for Ovarian Cancer

NCT ID: NCT03877796

Last Updated: 2025-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-11

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ovarian Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Ovarian cancer patients

with formalin-fixed paraffin-embedded (FFPE) tumor tissue available

Drug Response Predictor® (DRP)

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Amarex Clinical Research

OTHER

Sponsor Role collaborator

Allarity Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status COMPLETED

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Swedish Center for Research and Innovation

Seattle, Washington, United States

Site Status RECRUITING

Beatson West of Scotland Cancer Centre

Glasgow, Scotland, United Kingdom

Site Status ACTIVE_NOT_RECRUITING

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

London, , United Kingdom

Site Status ACTIVE_NOT_RECRUITING

Countries

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United States United Kingdom

Central Contacts

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US: Kathleen Moore

Role: CONTACT

+1 405-271-8707

Europe: Rebecca Kristeleit

Role: CONTACT

Facility Contacts

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Christine Pappaterra, RN

Role: primary

405-271-8707

Karina Sills

Role: primary

206-386-2227

Other Identifiers

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2X-1000

Identifier Type: -

Identifier Source: org_study_id

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