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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: Completed Phase 1 study, sponsored by University of Colorado, Denver.
NCT02596503 is a Phase 1 study that has completed, run by University of Colorado, Denver. 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
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.
Primary Outcome
To estimate the recommended phase II dose of eribulin in combination with fixed-dose oral irinotecan in adolescents and young adults with relapsed/refractory solid tumors. A 3+3 trial design will be utilized. Accrual will continued based on DLT evaluation until the RP2D is established and at least 6 patients have been treated at this dose.
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 |
What the finished NCT02596503 record still lists
NCT02596503 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 Irinotecan is the first listed.
NCT02596503 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT02596503'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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