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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03877796
Other study ID # 2X-1000
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 11, 2019
Est. completion date December 2024

Study information

Verified date May 2024
Source Allarity Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The pre-screening study is established to pre-screen tumor samples from ovarian cancer patients to identify if they, at a later stage of their disease, will benefit from treatment with any investigational cancer drugs available to Oncology Venture, when these drugs are approved for future clinical studies by local authorities.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date December 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with histological confirmed epithelia ovarian cancer - Relapse after 2 or more chemotherapies for ovarian cancer - FFPE tumor tissue available Exclusion Criteria: - Other primary malignancy within the last 5 years prior to enrolment

Study Design


Intervention

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.

Locations

Country Name City State
United Kingdom Beatson West of Scotland Cancer Centre Glasgow Scotland
United Kingdom Guy's and St Thomas' NHS Foundation Trust, Guy's Hospital London
United States Dana-Farber Cancer Institute Boston Massachusetts
United States OU Health Stephenson Cancer Center Oklahoma City Oklahoma
United States Swedish Center for Research and Innovation Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
Allarity Therapeutics Amarex Clinical Research

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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