A Multicenter, Open-Label, Noncomparative Phase 1-2 Clinical And Pharmacokinetic Study Of Oral PD 0325901 In Patients With Advanced Cancer
- Age >= 18 years old
- Tumor accessible for biopsy and willingness to undergo baseline and 1 post treatment
- 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
- 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.
- 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
- 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.