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NCT Number: NCT03877796

Clinical Pre-screening Protocol for 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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Beatson West of Scotland Cancer Centre, Glasgow, Scotland, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drug Response Predictor® (DRP)

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.

Primary outcomes

  1. 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

Secondary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Europe: Rebecca Kristeleit

CONTACT

[email protected]

US: Kathleen Moore

CONTACT

[email protected]

+1 405-271-8707

Sponsors and collaborators

Lead sponsor

Allarity Therapeutics

Industry

Collaborators

  • Amarex Clinical Research

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Mar 18, 2019
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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