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NCT04067115 · ClinicalTrials.gov registry record · Phase 1
SARC037: A Phase I/II Study to Evaluate the Safety of Trabectedin in Combination With Irinotecan in Ewing Sarcoma Patients
A Phase 1 study, sponsored by Sarcoma Alliance for Research through Collaboration.
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
NCT04067115 is a Phase 1 study that has completed, run by Sarcoma Alliance for Research through Collaboration. The registered enrollment target is 37 participants.
The verdict
NCT04067115, a Phase 1 study, has completed, sponsored by Sarcoma Alliance for Research through Collaboration.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
Study Summary
This study evaluates the trabectedin and irinotecan in the treatment of Ewings sarcoma, with a EWS-FLI1 mutation. Patients will also receive an infusion of 18F-FLT in combination with a Positron Emission Tomography (PET) scan to help evaluate the effect of treatment.
Interventions
- DRUG Irinotecan
- DRUG Trabectedin 1 MG [Yondelis]
- DIAGNOSTIC_TEST tumor biopsy
- OTHER 3'-Deoxy-3'-18F Fluorothymidine (18F-FLT) Imaging
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2021-01-05 |
| Est. Completion | 2025-04-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04067115
The ClinicalTrials.gov registry entry for NCT04067115 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sarcoma Alliance for Research through Collaboration, which has 20 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Irinotecan is the first listed.
NCT04067115 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04067115 about?
NCT04067115 is a clinical study titled "SARC037: A Phase I/II Study to Evaluate the Safety of Trabectedin in Combination With Irinotecan in Ewing Sarcoma Patients". This study evaluates the trabectedin and irinotecan in the treatment of Ewings sarcoma, with a EWS-FLI1 mutation. Patients will also receive an infusion of 18F-FLT in combination with a Positron Emission Tomography (PET) scan to help evaluate the effect of treatment.
What is the current status of trial NCT04067115?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2021-01-05. Estimated completion is 2025-04-24.
What interventions are being tested in trial NCT04067115?
The interventions under investigation include: Irinotecan (DRUG), Trabectedin 1 MG [Yondelis] (DRUG), tumor biopsy (DIAGNOSTIC_TEST), 3'-Deoxy-3'-18F Fluorothymidine (18F-FLT) Imaging (OTHER).
Who is sponsoring clinical trial NCT04067115?
This trial is sponsored by Sarcoma Alliance for Research through Collaboration, which has 20 total clinical trials registered on ClinicalTrials.gov.
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