A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL647 Administered Orally to Subjects With Solid Tumors

Date de début de l'étude : 1 juin 2004

Inclusion Criteria: * The subject has a histologically confirmed malignancy that is metastatic or unresectable, and for which standard curative or palliative measures do not exist or are no longer effective, * The subject has disease that is assessable by tumor marker, physical, or radiologic means, * The subject is ≥18 years old, * There have been at least 4 weeks since prior chemotherapy or radiation therapy (6 weeks if the last treatment regimen included BCNU or mitomycin C), * The subject has an ECOG performance status ≤2 (Karnofsky \>60%), * The subject has a life expectancy of ≥3 months, * The subject has normal organ and marrow function (hemoglobin \>10g/dL, leukocytes \>3,000/mL, absolute neutrophil count \>1,500/µL, platelets \>100,000/µL, total bilirubin within normal institutional limits of normal,AST (SGOT)/ALT(SGPT) \<2.5 times the upper limit of normal, and creatinine within normal limits, * The subject is capable of understanding and complying with the protocol and has signed the informed consent document, * Sexually active subjects (both male and female) must use an accepted method of contraception during the course of the study, * Female subjects of childbearing potential (pre-menopausal) must have a negative pregnancy test. Exclusion Criteria: * The subject has had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or has not recovered from AEs due to agents administered more than 4 weeks earlier, * The subject has received another investigational agent within 30 days (or 5.5 half-lives) of the first dose of study drug, * The subject has known brain metastases, * The subject has a corrected QT interval (QTc) of \>0.44 seconds, * The subject has a history of allergic reactions attributed to aspartame or to any other component in the formulation vehicle, * The subject has an 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, * The subject is pregnant or nursing, * The subject is known to be positive for the human immunodeficiency virus (HIV).