SB-715992 in Treating Patients With Advanced or Metastatic Colorectal Cancer

Exclusion Criteria

• •Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from AEs due to agents administered more than 4 weeks earlier
• •Patients may not have received any other investigational agents within 28 days of study entry
• •Patients may not receive other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) while on this study
• •Prohibited medications; SB-715992 is a moderate to significant in vitro inhibitor of CYP3A4; the following lists of medications/substances are moderate to significant inhibitors/inducers of CYP3A4 that, if administered concomitantly with SB-715992, may alter study drug exposure; the use of these medications/substances within 14 days (\> 6 months for amiodarone) prior to the administration of the first dose of SB-715992 through discontinuation from the study is prohibited
• •* Inhibitors of CYP3A4:
• •* Antibiotics: clarithromycin, erythromycin, troleandomycin
• •* Antifungals: itraconazole, ketoconazole, fluconazole (doses \> 200 mg/day), voriconazole
• •* Antidepressants: nefazodone, fluovoxamine
• •* Calcium channel blockers: verapamil, diltiazem
• •* Miscellaneous: amiodarone\*, grapefruit juice, bitter orange
• •* Use of amiodarone within 6 months prior to the administration of the first dose of SB-715992 is prohibited
• •* Inducers of CYP3A4:
• •* Anticonvulsants: phenytoin, carbamazepine, Phenobarbital, oxcarbazepine
• •* Antibiotics: rifampin, rifabutin, rifapentine
• •* Miscellaneous: St. John's wort, modafinil
• •Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
• •History of allergic reactions attributed to compounds of similar chemical or biologic composition to SB-715992
• •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• •Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with SB-715992
• •HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study