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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up evaluated after up to approximately 2 years
Awards & highlights
PREDICT 2X-121 Trial 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.Check my eligibility
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.See study design
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.
PREDICT 2X-121 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Select...
My latest tumor test shows I'm likely to respond well to treatment.
Select...
I can carry out all my self-care but cannot do heavy physical work.
PREDICT 2X-121 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ evaluated after up to approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~evaluated after up to approximately 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR)
Secondary outcome measures
Clinical benefit rate (CBR)
Correlation between 2X-121 DRP® and clinical outcome
Duration of response
+3 morePREDICT 2X-121 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.
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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
7 Previous Clinical Trials
545 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have HIV.You have a medical condition that can be seen on a CT scan or MRI.I have not had a serious heart condition or stroke in the last 6 months.I have tumor tissue samples available from surgery.You are expected to live for more than 16 weeks.Your blood test results for neutrophils, hemoglobin, platelets, liver enzymes, bilirubin, alkaline phosphatase, creatinine, and blood urea should be normal.I have active hepatitis B or C.Women who could become pregnant must have a negative pregnancy test.I have recovered from any major side effects of my previous cancer treatments.I can take pills and do not have ongoing stomach or bowel problems.I am not currently receiving chemotherapy, radiotherapy, or hormonal therapy for my condition.I am 18 years old or older.My ovarian cancer has been treated with 2 or more chemotherapies, including possibly PARP inhibitors.I have had cancer before, but it was early stage and considered cured.I am currently on antibiotics for an infection.My latest tumor test shows I'm likely to respond well to treatment.It has been 3 months or more since my last platinum-based chemotherapy.I can carry out all my self-care but cannot do heavy physical work.I need urgent care to relieve my symptoms, possibly including surgery or radiation.
Research Study Groups:
This trial has the following groups:- Group 1: 2X-121
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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