Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by Sarcoma Alliance for Research through Collaboration.
NCT04067115 is a Phase 1 study that has completed, run by Sarcoma Alliance for Research through Collaboration. The registered enrollment target is 37 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The recommended dose will be established by enrolling patients at the lowest dose and observing them for dose limiting toxicity. Dose limiting toxicity describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment. The maximum tolerated dose is the highest dose of a drug or treatment that does not cause unacceptable side effects. If 0 of the first 3 subjects experience DLT, the study will proceed to the next dose level. If 1
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 |
What the finished NCT04067115 record still lists
NCT04067115 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 4 interventions - of which Irinotecan is the first listed.
NCT04067115 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04067115's enrollment target sits among peer trials
37 1204th of 2000 higher than 791 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02800486 · 37 participants · Phase 2
Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory GBM, AA, and AOA
- NCT03173937 · 37 participants · Phase 1
Unrelated Umbilical Cord Blood Transplantation for Severe Aplastic Anemia and Hypo-plastic MDS Using CordIn(TM), Umbilical Cord Blood-Derived Ex Vivo Expanded Stem and Progenitor Cells to Expedite Engraftment and Improve Transplant Outcome
- NCT03295227 · 37 participants · Phase 1
Pembrolizumab in Treating Participants With Unresectable Thymoma or Thymic Cancer
- NCT03401047 · 37 participants · Early Phase 1
Study to Assess Potential Impairments in Estradiol Augmentation of Gonadotropin Secretion in Polycystic Ovary Syndrome
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI