Clinical trial NCT00436605 (phase 2, status: completed)
Conditions: recurrent melanoma, stage iiia melanoma, stage iiib melanoma, stage iiic melanoma, stage iv melanoma
ICD codes: G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2, C43.0, C43.31, D03.9, C43.51, C43.9, D03.0, C43.4, C43.0, C43.31, D03.9, C43.51, C43.9, D03.0, C43.4, C43.0, C43.31, D03.9, C43.51, C43.9, D03.0, C43.4, C43.0, C43.31, D03.9, C43.51, C43.9, D03.0, C43.4
Drugs: dasatinib
SMILES: CC1=NC(NC2=NC=C(S2)C(=O)NC2=C(C)C=CC=C2Cl)=CC(=N1)N1CCN(CCO)CC1
Eligibility criteria:

        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