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PARP Inhibitor

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

Phase 2
Recruiting
Research Sponsored by Allarity Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
FFPEs tumor tissue should be available either from primary surgery or later
Recovered to Grade 1 or less from prior surgery or acute toxicities of prior radiotherapy, or treatment with cytotoxic, hormonal or biologic agents
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 below
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I have tumor tissue samples available from surgery.
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I have recovered from any major side effects of my previous cancer treatments.
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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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It has been 3 months or more since my last platinum-based chemotherapy.
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I can carry out all my self-care but cannot do heavy physical work.

PREDICT 2X-121 Trial 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

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 more

PREDICT 2X-121 Trial Design

1Treatment groups
Experimental Treatment
Group I: 2X-121Experimental Treatment2 Interventions
Oral administration of 2X-121 once 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
6 Previous Clinical Trials
521 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open positions for this clinical trial?

"This study, which was originally posted on April 15th 2019, is currently looking for patients. The last update to the listing was on October 7th 2022."

Answered by AI

Are there any risks associated with the use of 2X-121?

"2X-121 falls into the Phase 2 category, meaning that while there is data supporting its safety, there is none yet attesting to its efficacy. Our team at Power gave it a score of 2."

Answered by AI

How many patients are trialing this medication?

"Yes, this research is currently recruiting patients as the website clinicaltrials.gov indicates. The trial was established on April 15th, 2019 and was updated October 7th, 2020. 1 site is looking for a total of 60 individuals to participate."

Answered by AI

Have similar experiments been conducted before?

"To date, there is a single active clinical trial for 2X-121 being conducted in two metropolises and across two sovereign states. The first study of its kind was completed in 2019 by Allarity Therapeutics. This particular research project involved 60 test subjects and successfully completed Phase 2 drug approval. As of now, 1 additional trial has been carried out."

Answered by AI

What is the current understanding of 2X-121's efficacy?

"At the moment, 1 clinical trial is underway for 2X-121. 0 of those trials are in their third and final phase. Most of the research for 2X-121 is conducted in Glasgow, but studies are also taking place in Oklahoma at 4 different locations."

Answered by AI
~10 spots leftby Apr 2025