A Phase 2 Study of Oral MKC-1 Administered Twice Daily for 14 Consecutive Days Every 4 Weeks in Patients With Advanced or Metastatic Breast Cancer
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