Dasatinib in Treating Patients With Stage III Melanoma That Cannot Be Removed By Surgery or Stage IV Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00436605
Recruitment Status : Completed
First Posted : February 19, 2007
Results First Posted : January 20, 2014
Last Update Posted : May 15, 2014
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
This phase II trial is studying how well dasatinib works in treating patients with stage III melanoma that cannot be removed by surgery or stage IV melanoma. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Condition or disease Intervention/treatment Phase
Recurrent Melanoma Stage IIIA Melanoma Stage IIIB Melanoma Stage IIIC Melanoma Stage IV Melanoma Drug: dasatinib Phase 2

Detailed Description:


I. Determine the objective response rate in patients with stage III unresectable or stage IV melanoma treated with dasatinib.

II. Determine the progression-free survival of patients treated with this drug.


I. To assess the expression of targets of Dasatinib prior to treatment by obtaining pre-treatment biopsies or examining paraffin-embedded tissues from previous tumor resections.

II. In selected patients (approximately 5-10) where tumor tissue is available pre-treatment and can be obtained post-treatment with Dasatinib (21 days after initiation of therapy), to determine if Dasatinib induces changes in expression of selected targets and downstream mediators, including MEK, ERK and RSK-1.

III. To assess toxicity.


Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Dasatinib in Advanced Melanoma
Study Start Date : December 2006
Actual Primary Completion Date : March 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Dasatinib

Arm Intervention/treatment
Experimental: Treatment (kinase inhibitor therapy)
Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: dasatinib
Other Names:
  • BMS-354825
  • Sprycel

Primary Outcome Measures :
  1. Number of Subjects With Objective Response(Partial Response and Complete Response) as Measured by RECIST Criteria [ Time Frame: After every 8 weeks (or 2 courses), assessed up to 4 weeks after completion of treatment ]
    Only those patients who have measurable disease present at baseline, have received at least one course of therapy, and have had their disease re-evaluated will be considered evaluable for response. A Simon's optimum two-stage design will be used.

  2. Progression-free Survival [ Time Frame: Time from start treatment to time of progression, assessed up to 6 months ]
    Progression will be evaluated in this study using the new international criteria proposed by the RECIST Committee. A Simon's optimum two-stage design will be used

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed stage III unresectable or stage IV melanoma
  • Measurable disease
  • Must have evidence of tumor growth or new lesions within the past 6 months
  • No large pleural effusions
  • No known brain metastases or leptomeningeal metastases

    • Previously treated brain metastases allowed provided there is no requirement for steroids AND no evidence of progression for ≥ 8 weeks after treatment
  • ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
  • Life expectancy > 3 months
  • WBC ≥ 3,000/mm³
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9.0 g/dL (transfusions allowed)
  • Bilirubin ≤ 1.5 mg/mL
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • PT/INR and PTT normal
  • Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
  • No medical condition that may affect the ability to swallow and retain dasatinib tablets, including any of the following:

    • Gastrointestinal tract disease resulting in an inability to take oral medication
    • Requirement for IV alimentation
    • Prior surgical procedures affecting absorption
    • Active peptic ulcer disease
  • No clinically significant cardiovascular disease, including any of the following:

    • Myocardial infarction or ventricular tachyarrhythmia within the past 6 months
    • Prolonged QTc > 480 msec
    • Major conduction abnormality (unless a cardiac pacemaker is present)
  • No uncontrolled intercurrent illness including, but not limited to, any of the following:

    • Ongoing or active infection
    • History of significant congenital or acquired bleeding disorder, including any of the following:

      • Von Willebrand's disease
      • Antifactor VIII antibodies
    • Dyspnea at rest or with minimal exertion
    • Uncontrolled seizure disorder
    • Psychiatric illness or social situations that would preclude study compliance
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other active malignancy within the past 3 years except curatively treated stage I malignancies or resected skin carcinomas
  • Recovered from prior therapy
  • Prior adjuvant therapy for stage II or III melanoma allowed
  • No prior cytotoxic therapy for metastatic melanoma
  • No prior dasatinib or other inhibitors of src, bcr-abl, c-Kit, EPHA2, and PDGFRβ
  • No more than 2 prior immunomodulator therapies for metastatic melanoma
  • At least 1 week since prior and no concurrent warfarin or other anticoagulants or medications that inhibit platelet function (including acetylsalicylic acid)
  • At least 1 week since prior and no concurrent steroids or other immunosuppressive agents

    • Concurrent steroids to treat induced pleural effusions allowed
  • At least 3 weeks since prior immunomodulators including, but not limited to, any of the following:

    • Aldesleukin
    • Cancer vaccines
    • T-cell-activating monoclonal antibodies
  • At least 4 weeks since prior radiotherapy

    • Prior palliative radiotherapy to a single site of disease allowed (tumor is not considered evaluable for response unless there is tumor progression at the site of radiation)
  • More than 7 days since prior and no concurrent CYP3A4 inhibitors
  • At least 7 days since prior and no concurrent agents with proarrhythmic potential
  • No other concurrent investigational agents
  • No other concurrent anticancer agents or therapies
  • No concurrent enzyme-inducing anticonvulsant agents
  • No concurrent grapefruit or grapefruit juice
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent CYP3A4 inducers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00436605

United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
United States, Minnesota
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Harriet Kluger Yale University

Responsible Party: National Cancer Institute (NCI) Identifier: NCT00436605     History of Changes
Other Study ID Numbers: NCI-2009-00219
NCI-2009-00219 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
HIC#0608001765 ( Other Identifier: Yale University )
7758 ( Other Identifier: CTEP )
P30CA016359 ( U.S. NIH Grant/Contract )
First Posted: February 19, 2007    Key Record Dates
Results First Posted: January 20, 2014
Last Update Posted: May 15, 2014
Last Verified: October 2011

Additional relevant MeSH terms:
Nevi and Melanomas
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action