Clinical trial NCT00568646 (phase 2, status: completed)
Conditions: pancreatic cancer
ICD codes: C25.3
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:

          -  Provide written informed consent and Health Insurance Portability and Accountability
             Act authorization for release of protected health information before any study related
             assessments

          -  Have histologically confirmed pancreatic cancer and measurable disease according to
             RECIST

          -  Have failed at least one prior chemotherapy regimen in either the neoadjuvant,
             adjuvant, or first-line metastatic setting

          -  Be at least 18 years of age at the time of consent

          -  Have an Eastern Cooperative Oncology Group performance status of 0 or 1

          -  Have the following laboratory results, within 10 days before the first MKC 1
             administration:

               1. Hemoglobin greater than or equal to 9 g/dL

               2. Absolute neutrophil count greater than or equal to 1.5 x 109 cells/L

               3. Platelet count greater than or equal to 75 x 109 cells/L

               4. Serum creatinine less than or equal to 1.5 times the upper limit of normal (ULN)

               5. Aspartate transaminase less than or equal to 2.5 times the ULN

               6. Serum albumin greater than or equal to 3.0 g/dL

               7. Total bilirubin less than or equal to the ULN

        Exclusion Criteria:

          -  Be a pregnant or breast-feeding woman. Female patients must be postmenopausal,
             surgically sterile, or they must agree to use a barrier method of contraception.
             Female patients of childbearing potential must have a negative pregnancy test within
             the 10 days before the first MKC 1 administration. Male patients must be surgically
             sterile or agree to use an acceptable method of contraception.

          -  Have known central nervous system metastases unless they are being treated, are
             clinically stable, and do not require the use of steroids.

          -  Have clinical evidence of significant bowel obstruction, active uncontrolled
             malabsorption syndromes, or a history of total gastrectomy.

          -  Have uncontrolled hypercalcemia (serum calcium-corrected greater than 12 mg/dL).

          -  Have a serious cardiac condition (Class III/IV congestive heart failure according to
             New York Heart Association classification) or documented acute myocardial infarction
             within the previous 6 months.

          -  Have any medical conditions that, in the investigator's opinion, would impose
             excessive risk to the patient. These conditions include: infection requiring
             parenteral or oral anti-infective treatment or any altered mental status or any
             psychiatric condition that would interfere with the understanding of the informed
             consent.

          -  Have had previous malignancies, unless free of recurrence for at least 5 years except
             cured basal cell carcinoma of the skin or carcinoma-in-situ of the uterine cervix.

          -  Be receiving treatment with antiretroviral therapy metabolized through CYP3A4
             (including indinavir, nelfinavir, ritonavir, and saquinavir, or any other medications
             that interfere with CYP3A4).

          -  Have, in the opinion of the investigator, any clinically significant existing
             toxicities from previous chemotherapy therapies.