Phase 2 Study of Oral MKC-1 in Patients With Unresectable or Metastatic Pancreatic Cancer

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:

• Hemoglobin greater than or equal to 9 g/dL
• Absolute neutrophil count greater than or equal to 1.5 x 109 cells/L
• Platelet count greater than or equal to 75 x 109 cells/L
• Serum creatinine less than or equal to 1.5 times the upper limit of normal (ULN)
• Aspartate transaminase less than or equal to 2.5 times the ULN
• Serum albumin greater than or equal to 3.0 g/dL
• 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.