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A Phase I/II Study of Dasatinib and Dacarbazine

NCT00597038 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2013-12-16

Study results available
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Summary

The purpose of this study is to:

Phase I Objectives:

* Find the most tolerated dose to use for Phase II
* Collect information on how the body responds to this combination of study drug

Phase II Objectives:

* To determine the overall response of participants using this combination of study drug

The expression of proto-oncogene tyrosine-protein kinase (Src), a substance present in a significant proportion of melanomas plays a role in the growth, multiplying, and dividing of cancer cells. Melanoma cells appear to be sensitive to these agents that block the action of Src in concentrations that can be achieved in patients. We suggest that Src inhibitors (such as Dasatinib) may be a good choice for treatment of melanoma in combination with Dacarbazine (a chemotherapy drug that can cause the shrinkage of melanomas). We wish to to evaluate the Src inhibitor Dasatinib in combination with the chemotherapy drug Dacarbazine. The novel oral Src inhibitor Dasatinib may be able to increase the effectiveness of chemotherapy for melanoma compared to chemotherapy alone. Dacarbazine is a standard treatment for melanoma currently. The effectiveness of this chemotherapy drug may be increased by combination with Dasatinib. Dacarbazine has been approved by the US Food and Drug Administration (FDA) for treating melanoma; Dasatinib has been approved by the FDA to treat leukemia, but it has not been approved alone or in combination with Dacarbazine to treat melanoma.

Conditions

Interventions

DRUG

Dasatinib and Dacarbazine (DTIC)

Arm A/ Phase I Potential Dose Levels. Dose Level -1: Dasatinib 40 mg; DTIC 600 mg/m\^2. Dose Level 1: Dasatinib 50 mg; DTIC 800 mg/m\^2. Dose Level 2: Dasatinib 70 mg; DTIC 800 mg/m\^2. Dose Level 3: Dasatinib 70 mg; DTIC 1000 mg/m\^2. Arm B/Phase II Potential Dose Levels. MTD1: Dasatinib 70 mg; DTIC 1000 mg/m\^2. MTD2: Dasatinib 70 mg; DTIC 800 mg/m\^2. MTD3: Dasatinib 100 mg: DTIC 1000 mg/m\^2.

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Jeffrey Weber, M.D.. Ph.D. · H. Lee Moffitt Cancer Center and Research Institute

  • Adil Daud, M.D. · Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United States

Study Locations

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Entities

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 NCT00597038 on ClinicalTrials.gov