Clinical trial NCT00357318 (phase 1, status: completed)
Conditions: unspecified adult solid tumor, protocol specific
ICD codes: H01.009, H02.209, H02.009, H02.109, H04.209, H05.409, H10.509
Drugs: sunitinib malate
SMILES: CCN(CC)CCNC(=O)C1=C(C)NC(\C=C2/C(=O)NC3=C2C=C(F)C=C3)=C1C
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven metastatic/unresectable adrenocortical carcinoma or melanoma not
             amenable to curative surgical or radiation therapy.

          -  Accrual closed as of 5/27/2009 to patients with renal cell carcinoma

          -  No squamous cell histology

          -  No histology in close proximity to a major blood vessel

          -  No history of or known brain metastases, spinal cord compression, or carcinomatous
             meningitis

          -  No new evidence of brain or leptomeningeal disease on screening CT scan or MRI

          -  ECOG performance status (PS) 0-1 OR Karnofsky PS 60-100%

          -  AST and ALT ≤ 2.5 times upper limit of normal (ULN)

          -  Bilirubin ≤ 1.5 times ULN

          -  Creatinine ≤ 1.5 times ULN

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  Platelet count ≥100,000/mm³

          -  Hemoglobin ≥ 10.0 g/dL

          -  Calcium ≤ 12.0 mg/dL

          -  Urine protein:creatinine ratio ≤ 0.5 by urinalysis

          -  Patients with urine protein:creatinine ratio > 0.5 must have proteinuria < 1,000 mg by
             24-hour urine collection

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for ≥ 6 months after
             completion of study therapy

          -  None of the following within the past 12 months:

               -  Myocardial infarction

               -  Severe/unstable angina

               -  Severe peripheral vascular disease (claudication) or procedure on peripheral
                  vasculature

               -  Coronary/peripheral artery bypass graft

               -  New York Heart Association (NYHA) grade III-IV congestive heart failure

               -  Cerebrovascular accident or transient ischemic attack

               -  Clinically significant bleeding

               -  Deep venous thrombosis

               -  Pulmonary embolism

               -  No ongoing cardiac dysrhythmias of NCI CTCAE ≥ grade 2, atrial fibrillation of
                  any grade, or prolongation of the QTc interval to > 450 msec (males) or > 470
                  msec (females)

               -  No history of serious ventricular arrhythmia (i.e., ventricular tachycardia or
                  ventricular fibrillation ≥ 3 beats in a row)

               -  No condition classified as NYHA grade III or IV

               -  No hypertension that cannot be controlled by medications

               -  Blood pressure < 140/90 mm Hg

               -  No evidence of bleeding diathesis or coagulopathy

               -  No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal
                  abscess within the past 28 days

               -  No history of or known brain metastases, spinal cord compression or carcinomatous
                  meningitis, or new evidence of brain or leptomeningeal disease on screening CT or
                  MRI scan unless without progression on * MRI or CT for 3 months."

               -  No significant traumatic injury within the past 28 days

               -  No serious, non-healing wound, ulcer, or bone fracture

               -  No known hypersensitivity to Chinese hamster ovary cell products or other
                  recombinant human antibodies

               -  No known HIV or AIDS-related illness

               -  No other severe acute or chronic medical or psychiatric condition or laboratory
                  abnormality that would preclude study participation.

          -  Recovered from prior radiation therapy, surgery, or other prior therapy

          -  No prior bevacizumab or sunitinib malate (SU11248)

          -  Other antiangiogenic therapies allowed

          -  No prior tyrosine kinase inhibitor of the VEGF receptor or bevacizumab for patients
             with metastatic renal cell carcinoma

          -  No major surgical procedures or open biopsy within the past 28 days

          -  No core biopsy within the past 7 days

          -  No radiation therapy or systemic therapy within the past 4 weeks

          -  No concurrent full-dose anticoagulants (e.g., warfarin)

          -  Concurrent low-dose anticoagulation (e.g., prophylactic port patency) allowed

          -  No concurrent treatment on another clinical trial

          -  No other concurrent investigational drugs

          -  No concurrent major surgery

          -  No other concurrent anticancer agents or therapies, including chemotherapy, biological
             response modifiers, hormonal therapy, surgery, palliative radiation therapy, or
             immunotherapy