RecruitingPhase 2NCT03878849

Investigation of the Anti-tumor Effect of 2X-121 in Patients With Recurrent, Advanced Ovarian Cancer

Phase 2, Randomized, Prospective, Open-Label, Parallel-Arm, Dose Optimization Study to Investigate the Safety, Tolerability, PK/PD, and Anti- Tumor Effect of 2X-121 in Patients With Recurrent, Advanced Ovarian Cancer.


Sponsor

Allarity Therapeutics

Enrollment

40 participants

Start Date

Apr 15, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the optimal dose of 2X-121 as single agent therapy at 600 mg daily (split BID 200 mg morning + 400 mg evening) compared to 800 mg daily (split BID 400 mg morning + 400 mg evening) in recurrent, advanced ovarian cancer patients that have platinum-resistant disease, defined as progression within 6 months after the last dose of platinum-based chemotherapy, or are platinum ineligible. The optimal dose will be selected based on an integrated analysis of PK/PD, safety, and efficacy data.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an experimental oral drug called 2X-121 — a PARP inhibitor that blocks a protein cancer cells use to repair their DNA — in women with advanced ovarian cancer that has stopped responding to standard platinum chemotherapy. **You may be eligible if...** - You are 18 or older - You have ovarian, fallopian tube, or peritoneal cancer confirmed by biopsy (high-grade serous or endometrioid type) - Your cancer no longer responds to platinum chemotherapy — progressed within 6 months, or you are ineligible for platinum - You have received no more than one prior treatment since your cancer became platinum-resistant - You have measurable disease visible on CT or MRI scan **You may NOT be eligible if...** - You have already received more than one line of treatment after becoming platinum-resistant - You have conditions affecting blood counts, kidney, liver, or heart function - You are pregnant or breastfeeding - You have had a prior bone marrow transplant or certain prior therapies Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG2X-121

2X-121 will be administered daily as 600 mg (200 mg 2X-121 morning dose + 400 mg (2 x 200 mg) 2X-121 evening dose) hard gelatin capsules in a 28 days cycle.

DRUG2X-121

2X-121 will be administered daily as 800 mg (400 mg (2 x 200 mg) 2X-121 morning dose + 400 mg (2 x 200 mg) 2X-121 evening dose) hard gelatin capsules in a 28 days cycle.


Locations(2)

OU Health Stephenson Cancer

Oklahoma City, Oklahoma, United States

Swedish Center for Research and Innovation

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT03878849


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