A Phase 2 Study of Oral MKC-1 in Patients With Ovarian or Endometrial Cancer

Exclusion Criteria

• •1. 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.
• •2. Requirement for paracentesis \> 2 liters/week.
• •3. Pregnant or breast-feeding women. Female patients must be postmenopausal, surgically sterile, or they must agree to use a physical method of contraception. Female patient with childbearing potential must have a negative pregnancy test within 10 days before the first MKC-1 administration.
• •4. Known CNS metastases unless treated, clinically stable, and not requiring steroids.
• •5. Clinical evidence of significant bowel obstruction, active uncontrolled malabsorption syndromes, or a history of total gastrectomy.
• •6. Uncontrolled hypercalcemia (serum calcium-corrected \> 3 mmol/L \[12 mg/dL\]).
• •7. Serious cardiac condition (Class III/IV congestive heart failure according to New York Heart Association classification); documented acute myocardial infarction within the previous 6 months.
• •8. Any medical conditions that, in the investigator's opinion, would impose excessive risk to the patient. These include: infection requiring parenteral or oral anti-infective treatment, any altered mental status, or any psychiatric condition that would interfere with the understanding of the informed consent.
• •9. Patients with 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.
• •10. Treatment with antiretroviral therapy metabolized through CYP3A4 (including indinavir, nelfinavir, ritonavir and saquinavir).