Clinical Pre-screening Protocol for Ovarian Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorAllarity Therapeutics

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Ovarian cancer patients1 intervention

Trial outcomes

Primary outcomes

1

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

based on FFPE ovarian cancer tissue

Time frame
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

Time frame
up to 2 years

Other outcomes

Sponsors and contacts

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Allarity Therapeutics

Lead sponsor

Amarex Clinical Research

Collaborator