NCT03877796

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
7mo left

Started Apr 2019

Longer than P75 for all trials

Geographic Reach
2 countries

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Apr 2019Dec 2026

First Submitted

Initial submission to the registry

March 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2019

Completed
24 days until next milestone

Study Start

First participant enrolled

April 11, 2019

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

October 30, 2025

Status Verified

October 1, 2025

Enrollment Period

7.4 years

First QC Date

March 14, 2019

Last Update Submit

October 28, 2025

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • Identification of ovarian cancer patients with high likelihood of being sensitive to investigational cancer drug

    based on FFPE ovarian cancer tissue

    up to 2 years

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

    up to 2 years

Study Arms (1)

Ovarian cancer patients

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

Device: Drug Response Predictor® (DRP)

Interventions

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.

Ovarian cancer patients

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

COMPLETED

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Swedish Center for Research and Innovation

Seattle, Washington, 98122, United States

RECRUITING

Beatson West of Scotland Cancer Centre

Glasgow, Scotland, G12 0YN, United Kingdom

ACTIVE NOT RECRUITING

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

London, United Kingdom

ACTIVE NOT RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Samples with archival ovarian cancer tumor tissue is collected for measurement using mRNA or microRNA.

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Central Study Contacts

US: Kathleen Moore

CONTACT

+1 405-271-8707KathleenMoore@ouhealth.com

Europe: Rebecca Kristeleit

CONTACT

Rebecca.Kristeleit@gstt.nhs.uk

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2019

First Posted

March 18, 2019

Study Start

April 11, 2019

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

October 30, 2025

Record last verified: 2025-10

Locations

GB(2)US(3)