Clinical trial NCT00306631 (phase 2, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: mkc-1
SMILES: CN1C=C(C2=CC=CC=C12)C1=C(C(=O)NC1=O)C1=CN(C)C2=CC(=CC=C12)[N+]([O-])=O
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed advanced or metastatic adenocarcinoma of the
             breast

          -  18 years or older

          -  Karnofsky performance status greater than or equal to 70%

          -  Radiographic or physical examination evidence of at least one site of
             unidimensionally-measurable disease, using the Response Evaluation Criteria in Solid
             Tumors (RECIST) criteria

          -  Must have failed both a taxane and an anthracycline, given sequentially or in
             combination, either in an adjuvant or metastatic setting

          -  All acute toxicity of any prior chemotherapy, surgery or radiotherapy must have
             resolved to National Cancer Institute Common Toxicity Criteria (NCI CTC) Grade less
             than or equal to 1

          -  Lab results, within 10 days of MKC-1 administration:

               -  Hemoglobin less than or equal to 9 g/dL

               -  Absolute neutrophil count greater than or equal to 1.5 x 10^9/L

               -  Platelet count greater than or equal to 75 x 10^9/L

               -  Serum creatinine less than or equal to 1.5 x ULN (upper limit of normal)

               -  AST less than or equal to 2.5 x ULN

               -  Serum albumin greater than or equal to LLN (lower limit of normal)

               -  Total bilirubin less than or equal to ULN

               -  Alkaline phosphatase less than or equal to 2.5 x ULN

          -  Signed informed consent

        Exclusion Criteria:

          -  Pre-existing hepatomegaly with disease measures greater than or equal to 2 cm below
             the costal margin, secondary to malignancy

          -  Administration of cancer specific therapy within the following periods prior to study
             drug initiation:

               -  chemotherapy less than 3 weeks prior

               -  hormonal therapy less than one week prior

               -  radiation therapy less than 2 weeks prior

          -  Be pregnant or lactating; not employing effective birth control

          -  Known central nervous system (CNS) metastases unless treated, clinically stable and
             not requiring steroids

          -  Clinical evidence of bowel obstruction, active uncontrolled malabsorption syndromes or
             a history of total gastrectomy

          -  Administration of any investigational agent (therapeutic or diagnostic) within 4 weeks
             prior to receipt of study medication

          -  Uncontrolled hypercalcemia (serum calcium-corrected greater than 12 mg/dL)

          -  Serious cardiac condition

          -  Any medical conditions that, in the investigator's opinion would impose excessive risk
             to the patient

          -  Patients with previous malignancies unless free of recurrence for at least 5 years
             except basal cell carcinoma of the skin or carcinoma-in-situ of the uterine cervix

          -  Treatment with antiretroviral therapy metabolized through CYP3A4