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

A Phase 2 Study of Oral MKC 1, Administered Twice Daily for 14 Consecutive Days in a 28-Day Cycle, in Patients With Unresectable or Metastatic Pancreatic Cancer Who Have Failed at Least One Prior Chemotherapy Regimen in Either the Neoadjuvant, Adjuvant, or First-line Metastatic Setting

To determine the antitumor activity of MKC-1 in patients with unresectable or metastatic pancreatic cancer who have failed at least one prior chemotherapy regimen in either the neoadjuvant, adjuvant, or first-line metastatic setting

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.