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A Study of Dasatinib, Cetuximab and Radiation With or Without Cisplatin in HNSCC

NCT00882583 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2019-01-09

Study results available
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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

Conditions

Interventions

DRUG

Cetuximab

single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8

DRUG

Dasatinib

Oral Dasatinib Days 8 through 64.

DRUG

Cisplatin

Q 3 weeks (Days 15, 36 and 57): +/- 3 Days

RADIATION

Radiation Therapy

Standard Radiation Therapy.

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Shanthi Marur, MD · Johns Hopkins Universtiy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00882583 on ClinicalTrials.gov