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PARP Inhibitor

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

Phase 2
Waitlist Available
Research Sponsored by Allarity Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years or older
Histologically or cytologically documented ovarian carcinoma with ≥ 2 or more previous chemotherapies including potential treatment with other PARP inhibitors (PARPi)
Must not have
Clinical significant (i.e. active) cardiovascular disease: Stroke within ≤ 6 months prior to day 1, Transient ischemic attack (TIA) within ≤ 6 months prior to day 1, Myocardial infarction within ≤ 6 months prior to day 1, Unstable angina, New York Hart Association (NYHA) Grade II or greater congestive heart failure (CHF), Serious cardiac arrhythmia requiring medication
Known active hepatitis B or C
Timeline
Screening 3 weeks
Treatment Varies
Follow Up evaluated after up to approximately 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test the effectiveness of 2X-121, given as a pill once daily, as a treatment for ovarian cancer in patients predicted to respond well to the drug.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
While not explicitly listed here, potential side effects may include those common with cancer therapies such as fatigue, nausea, digestive issues, blood cell count changes leading to increased infection risk or bleeding problems, liver function alterations, and other organ-related complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My ovarian cancer has been treated with 2 or more chemotherapies, including possibly PARP inhibitors.
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My latest tumor test shows I'm likely to respond well to treatment.
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I can carry out all my self-care but cannot do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had a serious heart condition or stroke in the last 6 months.
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I have active hepatitis B or C.
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I can take pills and do not have ongoing stomach or bowel problems.
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I am not currently receiving chemotherapy, radiotherapy, or hormonal therapy for my condition.
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I am currently on antibiotics for an infection.
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I need urgent care to relieve my symptoms, possibly including surgery or radiation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~evaluated after up to approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and evaluated after up to approximately 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective response rate (ORR)
Secondary study objectives
Clinical benefit rate (CBR)
Correlation between 2X-121 DRP® and clinical outcome
Duration of response
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Find a Location

Who is running the clinical trial?

Allarity TherapeuticsLead Sponsor
7 Previous Clinical Trials
268 Total Patients Enrolled
1 Trials studying Ovarian Cancer
60 Patients Enrolled for Ovarian Cancer
Alcedis GmbHIndustry Sponsor
8 Previous Clinical Trials
588 Total Patients Enrolled
Amarex Clinical ResearchOTHER
26 Previous Clinical Trials
1,622 Total Patients Enrolled
1 Trials studying Ovarian Cancer
60 Patients Enrolled for Ovarian Cancer

Media Library

2X-121 (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03878849 — Phase 2
Ovarian Cancer Research Study Groups: 2X-121
Ovarian Cancer Clinical Trial 2023: 2X-121 Highlights & Side Effects. Trial Name: NCT03878849 — Phase 2
2X-121 (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03878849 — Phase 2
~9 spots leftby Dec 2025
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