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Phase I Study of CUDC-101 With Cisplatin and Radiation in Subjects With Head & Neck Cancer
NCT01384799 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01384799
The ClinicalTrials.gov registry entry for NCT01384799 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Curis, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01384799 reports 7 study locations spanning 7 distinct geographic areas — top geographies include California, Colorado, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01384799?
The interventions under investigation include: Cisplatin (DRUG), Radiation Therapy (RADIATION), CUDC-101 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01384799?
This trial is sponsored by Curis, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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