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NCT01744340 · ClinicalTrials.gov registry record · Phase 1
A Dose Finding Study of Eribulin Mesylate and Cetuximab For Patients With Advanced Head and Neck and Colon Cancer
A Phase 1 study, sponsored by howard safran.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT01744340: Completed Phase 1 study, sponsored by howard safran.
NCT01744340 is a Phase 1 study that has completed, run by howard safran. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01744340, a Phase 1 study, has completed, sponsored by howard safran.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if the full dose of eribulin mesylate can be safely given with the full dose of cetuximab. The activity of the combination of eribulin mesylate and cetuximab on recurrent head and neck cancer and colon cancer will also be assessed.
Primary Outcome
A DLT was defined as: * Grade 4 neutropenia (ANC \< 500/mm3) for \> 7 days * ANC \<1000/mm3 with fever or infection * Platelets \<25,000/mm3 * Platelets \<50,000/mm3 requiring transfusion * Grade 3 or grade 4 treatment related non-hematologic toxicities excluding alopecia. Grade 3 nausea, vomiting or diarrhea will only be considered a dose limiting toxicity if it occurs despite maximal medical support. Grade 3 or grade 4 hypomagnesemia will not be considered a dose limiting toxicity since it is
Interventions
- DRUG Head and neck
- DRUG Colon- Closed as of May 2014
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2012-05 |
| Est. Completion | 2015-07 |
| Phase | Phase 1 |
What the finished NCT01744340 record still lists
NCT01744340 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Head and neck is the first listed.
NCT01744340 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01744340 about?
NCT01744340 is a clinical study titled "A Dose Finding Study of Eribulin Mesylate and Cetuximab For Patients With Advanced Head and Neck and Colon Cancer". The purpose of this study is to determine if the full dose of eribulin mesylate can be safely given with the full dose of cetuximab. The activity of the combination of eribulin mesylate and cetuximab on recurrent head and neck cancer and colon cancer will also be assessed.
What is the current status of trial NCT01744340?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2012-05. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01744340?
The interventions under investigation include: Head and neck (DRUG), Colon- Closed as of May 2014 (DRUG).
Who is sponsoring clinical trial NCT01744340?
This trial is sponsored by howard safran, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01744340's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 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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