2X-121 for Ovarian Cancer
(PREDICT 2X-121 Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Allarity Therapeutics

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This study is to be performed as an open label, multicenter, single arm study of 2X-121 to evaluate anti-tumor efficacy of 2X-121 as single agent therapy in a 28-days cycle in advanced ovarian cancer patients. 2X-121 will be supplied for oral administration twice daily as 600 mg (3 x 200 mg) capsules in a 28 days cycle. Patients with predicted high likelihood of responding to the drug (2X-121) using drug response prediction (DRP®), will be included in the study.

Eligibility Criteria

This trial is for adults over 18 with advanced ovarian cancer who've had at least two prior chemotherapy treatments and a platinum-free interval of ≥3 months. Participants must have measurable disease, an ECOG performance status ≤1, life expectancy >16 weeks, and meet specific lab criteria. They should respond well to the drug as predicted by a special test (2X-121 DRP®) and be able to take oral medication.

Inclusion Criteria

You have a medical condition that can be seen on a CT scan or MRI.

I have tumor tissue samples available from surgery.

You are expected to live for more than 16 weeks.

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Exclusion Criteria

You have HIV.

Patients unable to be regularly followed for any reason (geographic, familiar, social, psychologic, housed in an institution eg. prison because of a court agreement or administrative order)

Other medications or conditions that in the investigator's opinion would contraindicate study participation of safety reasons or interfere with the interpretation of study results

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Treatment Details

Interventions

2X-121 (PARP Inhibitor)

Trial OverviewThe study tests the effectiveness of an oral drug called 2X-121 in patients with advanced ovarian cancer. Patients will take this drug daily in cycles of 28 days. The trial uses a Drug Response Predictor (DRP®) to select patients likely to benefit from the treatment.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: 2X-121Experimental Treatment2 Interventions

Oral administration of 2X-121 twice daily as 600 mg hard gelatin capsules in a 28 days cycle.