Study Of Safety And Tolerability Of GW786034 Given With Lapatinib In Cancer Patients

Inclusion criteria: Histologically or cytologically confirmed diagnosis of advanced solid tumor refractory to standard therapy or for whom there is no standard therapy. Females are eligible if they are of: a) Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who: had a hysterectomy. had a bilateral oophorectomy (ovariectomy). had a bilateral tubal ligation. is post-menopausal (a demonstration of total cessation of menses for 1 year). childbearing potential, has a negative serum pregnancy test at screening, and agrees to one of the following: an IUD with a documented failure rate of less than 1% per year. vasectomized partner who is sterile prior to the female patient's entry and is the sole sexual partner for that female. complete abstinence from sexual intercourse for 14 days before exposure to investigational product, throughout the clinical trial, and for at least 14 days after the last dose of investigational product. double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide). ECOG (Eastern Cooperative Oncology Group) PS 0 or 1. Adequate bone marrow function. Platelets greater than or equal to 75,000/mm3. ANC greater than or equal to 1,500/mm3 (1.5 x 109/L). Hgb greater than or equal to 9 g/dL (5 mmol/L). CLcr > 50 mL/min as calculated by the Cockcroft-Gault formula. Total bilirubin less than or equal to 1.5 x upper limit of normal. PT/INR/PTT less than or equal to 1.2 x upper limit of normal. AST/ALT less than or equal to 3 x upper limit of normal. Has LVEF within normal range or above 50% based on MUGA/ECHO. Urinalysis for protein is < 2 (negative, trace, or 1). NOTE: If urinalysis is 2 or greater then a 24 hour urine for protein must demonstrate less than 1 gram of protein in 24 hours for patient to be eligible for enrollment. Able to swallow and retain oral medication. Has a life expectancy of at least 12 weeks. Exclusion criteria: Had prior treatment with either study drug. Has brain metastases. Uncontrolled hypertension (BP higher than 150/90 SBP/DBP). Have heart failure. Have DVT (deep vein thrombosis) or arterial thrombosis, MI (myocardial infarction), angina, or has had angioplasty and/or stenting within last 3 months. Has allergy to drug similar to lapatinib (e.g. allergic to Iressa(gefitinib) or Tarceva(erlotinib). Is using therapeutic doses of anti-coagulant. Has had major surgery, hormonal therapy, chemotherapy, radiotherapy, or other investigational agent within last 28 days. Pregnant or lactating. History or current GI (gastrointestinal) condition that alters stomach or gut emptying from normal (e.g. major surgery on the stomach). Bowel obstruction or chronic diarrhea. Psychological or geographical conditions that would prevent him/her from being a good candidate. Do not have accessible veins for venipuncture. History of prolonged QTc on ECG.