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NCT03878849 · ClinicalTrials.gov registry record · Phase 2
Investigation of the Anti-tumor Effect of 2X-121 in Patients With Recurrent, Advanced Ovarian Cancer
A Phase 2 study of Advanced Ovarian Cancer, sponsored by Allarity Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 2
- Study locations
NCT03878849: Recruiting Phase 2 study of Advanced Ovarian Cancer, sponsored by Allarity Therapeutics.
NCT03878849 is a Phase 2 study of Advanced Ovarian Cancer that is actively recruiting participants, run by Allarity Therapeutics. The registered enrollment target is 40 participants, below the 697-participant average among 3 other Advanced Ovarian Cancer trials with a reported enrollment target (94% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03878849, a Phase 2 study of Advanced Ovarian Cancer, is actively recruiting participants, sponsored by Allarity Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
To evaluate the optimal dose of 2X-121 as single agent therapy at 600 mg daily compared to 800 mg daily.
Conditions Studied
Interventions
- DRUG 2X-121
Study Locations (2)
Oklahoma
- OU Health Stephenson Cancer - Oklahoma City
Washington
- Swedish Center for Research and Innovation - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2019-04-15 |
| Est. Completion | 2027-09 |
| Phase | Phase 2 |
What NCT03878849 shows while recruiting
NCT03878849 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 697-participant average among 3 other Advanced Ovarian Cancer trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Advanced Ovarian Cancer appearing as the primary indexed condition, and to 1 intervention - of which 2X-121 is the first listed.
NCT03878849 reports a single indexed study location in Oklahoma, Washington.
Frequently Asked Questions
What is clinical trial NCT03878849 about?
NCT03878849 is a clinical study titled "Investigation of the Anti-tumor Effect of 2X-121 in Patients With Recurrent, Advanced Ovarian Cancer". 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 dis...
What is the current status of trial NCT03878849?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2019-04-15. Estimated completion is 2027-09.
What conditions does trial NCT03878849 study?
This clinical trial studies the following conditions: Advanced Ovarian Cancer.
What interventions are being tested in trial NCT03878849?
The interventions under investigation include: 2X-121 (DRUG).
Who is sponsoring clinical trial NCT03878849?
This trial is sponsored by Allarity Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03878849 being conducted?
This trial has 2 study locations across Oklahoma, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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