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NCT04525014 · ClinicalTrials.gov registry record · Phase 1
RRx-001 Given With Irinotecan and Temozolomide for Pediatric Patients With Recurrent or Progressive Malignant Solid and Central Nervous System Tumors
A Phase 1 study, sponsored by EpicentRx.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT04525014: Clinical Trial Phase 1 study, sponsored by EpicentRx.
NCT04525014 is a Phase 1 study that was terminated before completion, run by EpicentRx. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04525014, a Phase 1 study, was terminated before completion, sponsored by EpicentRx.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
The PIRATE study tests the experimental drug RRx-001 in combination with 2 chemotherapy drugs that are commonly used in patients with cancer. RRx-001 has been used alone and with other anti-cancer medicines in adults. However, the investigators do not know what effects it will have in children and young adults.
Primary Outcome
Estimate the recommended phase 2 dose of RRx-001 administered every 3 weeks as an IV infusion in combination with oral irinotecan and temozolomide in pediatric patients with recurrent or progressive malignant solid or central nervous system (CNS) tumors.
Interventions
- DRUG Temozolomide
- DRUG Irinotecan
- DRUG RRx-001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2023-01-26 |
| Est. Completion | 2024-07-29 |
| Phase | Phase 1 |
Why NCT04525014 stopped before completion
NCT04525014 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 3 interventions - of which Temozolomide is the first listed.
NCT04525014 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04525014 about?
NCT04525014 is a clinical study titled "RRx-001 Given With Irinotecan and Temozolomide for Pediatric Patients With Recurrent or Progressive Malignant Solid and Central Nervous System Tumors". The PIRATE study tests the experimental drug RRx-001 in combination with 2 chemotherapy drugs that are commonly used in patients with cancer. RRx-001 has been used alone and with other anti-cancer medicines in adults. However, the investigators do not know what effects it will have in children and y...
What is the current status of trial NCT04525014?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2023-01-26. Estimated completion is 2024-07-29.
What interventions are being tested in trial NCT04525014?
The interventions under investigation include: Temozolomide (DRUG), Irinotecan (DRUG), RRx-001 (DRUG).
Who is sponsoring clinical trial NCT04525014?
This trial is sponsored by EpicentRx, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04525014's enrollment target sits among peer trials
2 2000th of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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