Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02596503 · ClinicalTrials.gov registry record · Phase 1
A Study of Eribulin in Combination With Oral Irinotecan for Adolescent and Young Adult Patients With Relapsed or Refractory Solid Tumors
A Phase 1 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT02596503 is a Phase 1 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 2 participants.
The verdict
NCT02596503, a Phase 1 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
This IND-exempt Phase I trial will establish the recommended Phase II (RP2D) dose of eribulin in combination with fixed doses of oral irinotecan in adolescents and young adults with relapsed or refractory solid tumors. Eribulin will be administered intravenously on days 1 and 8 of a 21-day cycle, while irinotecan will be administered orally on days 1-5. Patients will be assigned an eribulin dose level at the time of enrollment using a 3+3 Phase I design, and there will be no intrapatient dose escalation. Once the RP2D has been established, there will be up to 10 patients enrolled in a dose expansion cohort. In absence of disease progression or toxicity, subjects may receive up to 17 cycles of therapy.
Interventions
- DRUG Irinotecan
- DRUG Eribulin
- OTHER Cefixime
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2015-10-21 |
| Est. Completion | 2020-01-24 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02596503
The ClinicalTrials.gov registry entry for NCT02596503 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Irinotecan is the first listed.
NCT02596503 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02596503 about?
NCT02596503 is a clinical study titled "A Study of Eribulin in Combination With Oral Irinotecan for Adolescent and Young Adult Patients With Relapsed or Refractory Solid Tumors". This IND-exempt Phase I trial will establish the recommended Phase II (RP2D) dose of eribulin in combination with fixed doses of oral irinotecan in adolescents and young adults with relapsed or refractory solid tumors. Eribulin will be administered intravenously on days 1 and 8 of a 21-day cycle, wh...
What is the current status of trial NCT02596503?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2015-10-21. Estimated completion is 2020-01-24.
What interventions are being tested in trial NCT02596503?
The interventions under investigation include: Irinotecan (DRUG), Eribulin (DRUG), Cefixime (OTHER).
Who is sponsoring clinical trial NCT02596503?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.