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Safety Study Of Cetuximab Plus Dasatinib (BMS-354825) in Treating Advanced Solid Malignancies

NCT00388427 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2015-05-28

No results posted yet for this study

Summary

This is an open-label, safety study of cetuximab and differing dose levels of dasatinib in adult patients with advanced solid malignancies. Cetuximab will be administered as an intravenous infusion weekly. Dasatinib will be taken orally, once a day, on a continuous schedule at differing dose levels. The primary objective of this study is to determine the toxicities and the maximum tolerated doses of dasatinib when combined with cetuximab for the treatment of advanced solid tumors.

Conditions

  • Malignant Solid Tumour

Interventions

DRUG

Dasatinib (BMS-354825)

100 mg, 150 mg, or 200 mg per dose escalation schedule; continuous oral dosing on Days 1-21 of each 21-day cycle until progression or unacceptable toxicity develops.

DRUG

Cetuximab (Erbitux, C225)

Loading dose of IV 400 mg/m\^2 on Day 1 of Cycle 1; IV 250 mg/m\^2 weekly thereafter each 21-day cycle until progression or unacceptable toxicity develops.

Sponsors & Collaborators

Principal Investigators

  • Edward Chu, MD · University of Pittsburgh

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2009-07-31
Completion
2013-02-28

Countries

  • United States

Study Locations

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Entities

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 NCT00388427 on ClinicalTrials.gov