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A Phase 2 Study of Dasatinib in Advanced Melanoma

Phase 2
18 Years
Not Enrolling
Recurrent Melanoma, Stage IIIA Melanoma, Stage IIIB Melanoma, Stage IIIC Melanoma, Stage IV Melanoma

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Trial Information

A Phase 2 Study of Dasatinib in Advanced Melanoma


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

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.

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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate (partial response and complete response) as measured by RECIST criteria

Outcome Description:

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.

Outcome Time Frame:

After every 8 weeks (or 2 courses), assessed up to 4 weeks after completion of treatment

Safety Issue:


Principal Investigator

Harriet Kluger

Investigator Role:

Principal Investigator

Investigator Affiliation:

Yale University


United States: Food and Drug Administration

Study ID:




Start Date:

December 2006

Completion Date:

Related Keywords:

  • Recurrent Melanoma
  • Stage IIIA Melanoma
  • Stage IIIB Melanoma
  • Stage IIIC Melanoma
  • Stage IV Melanoma
  • Melanoma



Yale University New Haven, Connecticut  06520
Masonic Cancer Center, University of Minnesota Minneapolis, Minnesota  55455