MEK is a critical member of the MAPK pathway involved in growth and survival of cancer cells. PD-325901 is a new drug designed to block this pathway and kill cancer cells. The purpose of this study is to study the effectiveness of PD-325901 in patients with colon cancer, breast cancer, and melanoma. PD-325901 will be given by mouth as a pill twice a day, CT scans will be done and biopsies will be taken of a tumor before and once during treatment to measure the effects of the drug. Blood samples will be taken to measure the amount of drug in the blood.

Condition	Intervention	Phase
Melanoma Colonic Neoplasms Breast Neoplasms	Drug: PD-0325901	Phase I Phase II

Further Study Details: 

Primary Outcomes: Objective Response Rate, Safety.
Secondary Outcomes: Time to progression, overall survival, patient reported outcomes.
Expected Total Enrollment:  310

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Age >= 18 years old
• Tumor accessible for biopsy and willingness to undergo baseline and 1 posttreatment biopsy
• Biopsiable, histologically or cytologically confirmed metastatic or inoperable breast cancer, colon cancer, or melanoma. Prior treatment requirement : i) no more than 2 prior cytotoxic chemotherapy regimens for metastatic disease for patients with breast or colon cancers; ii) No prio cytotoxic therapy for patients with melanoma, or iii) measurable lesion (s) that have not been irradiated.
• Adequate renal, liver, and bone marrow function, determined within 2 weeks prior to the first treatment, defined as the following: Serum creatinine <1.5 x ULN, total bilirubin <2 x ULN, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <3 x ULN (<5 x ULN for patients with liver involvement); absolute neutrophil count (ANC) >1500/ul; and platelet >100,000/ul
• Hemoglobin >9.0 g/dL. Treatment with transfusions or erythropoietin to elevate the hemoglobin level for eligibility purposes is not permitted. Patients must have discontinued erythropoietin at least 2 weeks prior to the first dose of study medication
• Serum calcium <1 x ULN and phosphorus <1 x ULN
• Patients having reproductive potential must use adequate method of birth control. Patients may not be pregnant or breastfeeding.
• ECOG Status of 0,1, or 2.
• Must be able to swallow intact study medication and have no gastrointestinal disorders that may affect absorption of the drug
• Must be able to follow instructions or protocol specified procedures, or have a daily care giver who will be responsible for administering study medication.
• Must be able to give written informed consent.

Exclusion Criteria:

• No parathyroid disorder or history of malignancy associated hypercalcemia
• No ongoing radiation therapy or radio-cytotoxic therapy within prior 4 weeks; No immunotherapy, biologic therapy, hormonal, or molecular targeted therapy within prior 2 weeks
• No concurrent serious infection or life-threatening illness (unrelated to tumor)
• No history of any cancer other than the present condition (except nonmelanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission and off all therapy for that disease for a minimum of 3 years
• No untreated brain metastases.

Please refer to this study by ClinicalTrials.gov identifier  NCT00147550

Pfizer CT.gov Call Center      1-800-718-1021 

Alabama
      Pfizer Investigational Site, Birmingham,  Alabama,  35233,  United States; Recruiting
      Pfizer Investigational Site, Birmingham,  Alabama,  35233-2115,  United States; Recruiting
      Pfizer Investigational Site, Birmingham,  Alabama,  35294,  United States; Recruiting
Michigan
      Pfizer Investigational Site, Detroit,  Michigan,  48201,  United States; Recruiting
Minnesota
      Pfizer Investigational Site, Rochester,  Minnesota,  55905,  United States; Recruiting
Ohio
      Pfizer Investigational Site, Cleveland,  Ohio,  44106,  United States; Recruiting

Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

Study ID Numbers:  A4581001
Last Updated:  September 6, 2005
Record first received:  September 2, 2005
ClinicalTrials.gov Identifier:  NCT00147550
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13