| Exclusion Criteria: | Prior exposure to CI-1033 or other agents that target the erbB receptor family (such as Herceptin, Iressa, Tarceva, IMC-C225, and EKB-569.
Known hypersensitivity reaction to tyrosine kinase inhibitors.
Within 2 wks prior to randomization, total bilirubin >1.5 the upper limit of normal (ULN).
Within 2 wks prior to randomization, Serum ALT or AST > 2.5 x ULN (>5 x ULN for patients with documented liver mets).
Within 2 wks prior to randomization, creatinine clearance (CLcr, measured or calculated) <30 mL/min; if the calculated CLcr is <30 mL/min but a 24-hr collection shows CLcr =/> 30 mL/min, the pt is not excluded on the basis of CLcr.
Cytotoxic chemotherapy within 3 weeks prior to baseline disease assessments (6 weeks for nitrosoureas or mitomycin).
Immunotherapy (including Herceptin) or other biologic therapy within 2 weeks prior to baseline disease assessments.
Hormone therapy (including hormone replacement therapy) within 4 weeks prior to baseline disease assessments; 6 wks for megestrol acetate (to exclude the possibility of a hormone-withdrawal response).
Not yet recovered from the acute effects of radiation therapy or surgery.
Treatment with any other investigational therapy within 4 wks. prior to baseline disease assessments.
History of any cancer other than the present condition (except nonmelanoma skin cancer or carcinoma in situ of the cervix) within the last 5 years.
Pts.w/untreated brain mets. Pts. w/clinical evidence suggestive of new brain mets prior to randomization are excluded if brain mets have not been ruled out via CT or MRI.
Known malabsorption syndrome or other condition that may impair absorption of study meds.
Any comorbidity or condition which compromises compliance w/protocol or that would significantly complicate interpretation of the safety profile of CI-1033.
Patients having reproductive potential who are not using a method of birth control or who are pregnant or breastfeeding or have a positive pregnancy test during baseline.
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