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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 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.

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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.

Conditions Studied

Head and Neck Cancer

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

FieldValue
Enrollment Target 12 participants
Start Date 2011-11
Est. Completion 2013-10
Phase Phase 1

Sponsor

Curis

12 total trials

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What the Registry Record Tells You About NCT01384799

The ClinicalTrials.gov registry entry for NCT01384799 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (95% lower). The listed sponsor is Curis, which has 12 total studies on file at ClinicalTrials.gov.

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 reports 7 study locations spanning 7 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.