Clinical trial NCT00597038 (phase 1/phase 2, status: completed)
Conditions: metastatic melanoma
ICD codes: C43.0, C43.31, D03.9, C43.51, C43.9, D03.0, C43.4
Drugs: dasatinib and dacarbazine (dtic)
SMILES: CN(C)\N=N\C1=C(N=CN1)C(N)=O
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically proven melanoma with Stage IV or unresectable stage
             III disease

          -  Resolution of all acute toxic effects of prior radiotherapy or surgical procedures to
             National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
             Version 3.0 grade ≤1.

          -  Adequate organ function as defined by the following criteria:

               -  Serum aspartate transaminase (AST); serum glutamic oxaloacetic transaminase
                  (SGOT) and serum alanine transaminase (ALT); serum glutamic pyruvic transaminase
                  (SGPT) ≤2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less
                  than or equal to 5 x ULN if liver function abnormalities are due to underlying
                  malignancy

               -  Total serum bilirubin ≤1.5 x ULN

               -  Absolute neutrophil count (ANC) ≥1500/µL

               -  Platelets ≥100,000/µL

               -  Hemoglobin ≥9.0 g/dL (may be transfused or erythropoietin treated)

               -  Serum calcium ≤12.0 mg/dL

               -  Serum creatinine ≤1.5 x ULN

          -  Patients with CNS metastasis must have had either; a) resected central nervous system
             (CNS) metastasis without evidence of recurrence for >12 weeks; b) Brain metastasis
             treated by stereotactic radiosurgery without evidence of recurrence or progression for
             12 weeks; Or, c) Multiple brain lesions treated with whole-brain radiation therapy
             (WBRT) with stable disease off corticosteroids for at least 12 weeks prior to start of
             therapy; and, d)Without any evidence of leptomeningeal disease. Patients must be
             neurologically intact.

          -  May have previous adjuvant therapy with interferon, vaccines or therapy with IL-2 or
             GM-CSF

          -  Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
             is required in the Phase II portion of the trial. In the phase I part of the trial
             patients with evaluable but not measurable disease may be allowed with the permission
             of the Principal Investigator (PI)

          -  Eastern Cooperative Oncology Group (ECOG) PS 0-2

        Exclusion Criteria:

          -  Major surgery or radiation therapy within 4 weeks of starting the study treatment.

          -  NCI CTCAE grade 2 or greater hemorrhage within 4 weeks of starting the study
             treatment.

          -  History of or known carcinomatous meningitis, or evidence of symptomatic
             leptomeningeal disease on screening CT or MRI scan.

          -  Any of the following within the 6 months prior to study drug administration:
             myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
             graft, symptomatic congestive heart failure, cerebrovascular accident or transient
             ischemic attack, or pulmonary embolism.

          -  Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2.

          -  QTc >470 msec on baseline EKG.

          -  Hypertension that cannot be controlled by medications (>150/100 mm Hg despite optimal
             medical therapy).

          -  Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome
             (AIDS)-related illness or other active infection

          -  Ongoing treatment with therapeutic doses of warfarin (low dose warfarin up to 2 mg
             orally (po) daily for thromboembolism prophylaxis is allowed).

          -  Pregnancy or breastfeeding. Female patients must be surgically sterile or be
             postmenopausal, or must agree to use effective contraception during the period of
             therapy. All female patients with reproductive potential must have a negative
             pregnancy test (serum or urine) prior to enrollment. Male patients must be surgically
             sterile or must agree to use effective contraception during the period of therapy. The
             definition of effective contraception will be based on the judgment of the principal
             investigator or a designated associate.

          -  Other severe acute or chronic medical or psychiatric condition or laboratory
             abnormality that may increase the risk associated with study participation or study
             drug administration, or may interfere with the interpretation of study results, and in
             the judgment of the investigator would make the subject inappropriate for entry into
             this study.

          -  May not have had previous treatment with a Dacarbazine (DTIC) or temozolomide based
             chemotherapy regimen. In the Phase II part of the trial patients may not have had
             treatment with any chemotherapy regimen