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NCT00882583 · ClinicalTrials.gov registry record · Phase 1
A Study of Dasatinib, Cetuximab and Radiation With or Without Cisplatin in HNSCC
A Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Terminated
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT00882583: Clinical Trial Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT00882583 is a Phase 1 study that was terminated before completion, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00882583, a Phase 1 study, was terminated before completion, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
Primary Objective for Phase I 1. To determine the maximally tolerated dose (MTD) of daily Oral dasatinib in combination with cetuximab/RT in Cohort A. 2. To determine the MTD of daily oral dasatinib in combination with cisplatin/cetuximab/RT in Cohort B
Primary Outcome
The Maximum Tolerated Dose (MTD) for Dasatinib was defined as a) the dose producing DLT ( Dose limiting toxicity) in 0-1 out of 6 patients, or b) the dose level below the dose which produced DLT in \<2 out of 6 patients, or c) the dose of 150mg PO QD with less than 33% rate of DLT.
Interventions
- DRUG Cisplatin
- RADIATION Radiation Therapy
- DRUG Cetuximab
- DRUG Dasatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2009-07 |
| Est. Completion | 2016-02 |
| Phase | Phase 1 |
Why NCT00882583 stopped before completion
NCT00882583 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 4 interventions - of which Cisplatin is the first listed.
NCT00882583 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00882583 about?
NCT00882583 is a clinical study titled "A Study of Dasatinib, Cetuximab and Radiation With or Without Cisplatin in HNSCC". Primary Objective for Phase I 1. To determine the maximally tolerated dose (MTD) of daily Oral dasatinib in combination with cetuximab/RT in Cohort A. 2. To determine the MTD of daily oral dasatinib in combination with cisplatin/cetuximab/RT in Cohort B
What is the current status of trial NCT00882583?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2009-07. Estimated completion is 2016-02.
What interventions are being tested in trial NCT00882583?
The interventions under investigation include: Cisplatin (DRUG), Radiation Therapy (RADIATION), Cetuximab (DRUG), Dasatinib (DRUG).
Who is sponsoring clinical trial NCT00882583?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00882583's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 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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