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NCT01384799 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of CUDC-101 With Cisplatin and Radiation in Subjects With Head & Neck Cancer
A Phase 1 study of Head and Neck Cancer, sponsored by Curis.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 7
- Study locations
NCT01384799: Completed Phase 1 study of Head and Neck Cancer, sponsored by Curis.
NCT01384799 is a Phase 1 study of Head and Neck Cancer that has completed, run by Curis. The registered enrollment target is 12 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (95% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01384799, a Phase 1 study of Head and Neck Cancer, has completed, sponsored by Curis.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 7
- Study locations
Study Summary
This is a phase I dose escalation study of CUDC-101 in combination with concurrent cisplatin and radiation therapy in patients with locally advanced head and neck cancer. CUDC-101 is a multi-targeted agent designed to inhibit epidermal growth factor receptor (EGFR), human epidermal growth factor receptor Type 2 (Her2) and histone deacetylase (HDAC). The study is designed to establish the safety, tolerability and maximum tolerated dose (MTD) of CUDC-101 when administered in combination with concurrent cisplatin and radiation over an 8-week treatment course, consisting of a one week run-in period of CUDC-101 administered alone, followed by seven weeks of combination treatment with CUDC-101, cisplatin and radiation therapy.
Primary Outcome
Safety and tolerability will be assessed by evaluating the number of patients with adverse events
Conditions Studied
Interventions
- DRUG Cisplatin
- RADIATION Radiation Therapy
- DRUG CUDC-101
Study Locations (7)
California
- Stanford Cancer Center - Stanford
Colorado
- University of Colorado Cancer Center - Aurora
Louisiana
- Overton Brooks VA Medical Center - Shreveport
Massachusetts
- Massachusetts General Hospital - Boston
Michigan
- Henry Ford Health System - Detroit
Pennsylvania
- Fox Chase Cancer Center - Philadelphia
Tennessee
- Vanderbilt University - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2011-11 |
| Est. Completion | 2013-10 |
| Phase | Phase 1 |
What the finished NCT01384799 record still lists
NCT01384799 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Head and Neck Cancer appearing as the primary indexed condition, and to 3 interventions - of which Cisplatin is the first listed.
NCT01384799 lists 7 locations in 7 states (California, Colorado, Louisiana).
Frequently Asked Questions
What is clinical trial NCT01384799 about?
NCT01384799 is a clinical study titled "Phase I Study of CUDC-101 With Cisplatin and Radiation in Subjects With Head & Neck Cancer". This is a phase I dose escalation study of CUDC-101 in combination with concurrent cisplatin and radiation therapy in patients with locally advanced head and neck cancer. CUDC-101 is a multi-targeted agent designed to inhibit epidermal growth factor receptor (EGFR), human epidermal growth factor rec...
What is the current status of trial NCT01384799?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2011-11. Estimated completion is 2013-10.
What conditions does trial NCT01384799 study?
This clinical trial studies the following conditions: Head and Neck Cancer.
What interventions are being tested in trial NCT01384799?
The interventions under investigation include: Cisplatin (DRUG), Radiation Therapy (RADIATION), CUDC-101 (DRUG).
Who is sponsoring clinical trial NCT01384799?
This trial is sponsored by Curis, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01384799 being conducted?
This trial has 7 study locations across California, Colorado, Louisiana, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01384799's enrollment target sits among peer trials
12 232nd of 250 higher than 15 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Cancer 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.
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