A Study of Patupilone in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Function
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This phase I study will determine the pharmacokinetic profile of patupilone in patients with mild or moderately impaired hepatic function within 2 cycles of treatment. The study population for this trial consists of patients with a documented advanced solid tumor. Patients will be stratified into 3 groups: those with normal liver function, and those with mild or moderate liver dysfunction.
To assess the effect of hepatic impairment on the pharmacokinetics of patupilone and its metabolite [ Time Frame: After completion of the study (approximately 6 weeks from treatment) ]
To determine the maximum tolerated dose of patupilone in patients with hepatic impairment [ Time Frame: After completion of the study (approximately 6 weeks from treatment) ]
Secondary Outcome Measures
To correlate the level of hepatic dysfunction to observed toxicity and pharmacokinetics [ Time Frame: After completion of the study (approximately 6 weeks from treatment) ]
Safety and tolerability in patients with hepatic impairment will be assessed by adverse events (AEs), serious adverse events (SAEs) and out of range lab values [ Time Frame: After completion of the study (approximately 6 weeks from treatment) ]
To evaluate the preliminary anti-tumor activity which will be assessed by radiological scans every 6 weeks [ Time Frame: After completion of the study (approximately 6 weeks from treatment) ]
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
18 years of age or older
World Health Organization (WHO) Performance Status score of: 0 - you are fully active and more or less as you were before your illness; 1 - you cannot carry out heavy physical work, but can do anything else; or 2 - you are up and about more than half the day, you can look after yourself, but are not well enough to work.
Life expectancy of 3 months or more
Patients with measurable or evaluable disease who have histologically documented advanced solid tumor and who have progressed after systemic therapy or for whom standard systemic therapy does not exist
Severe and/or uncontrolled medical disease
Known diagnosis of human immunodeficiency virus (HIV) infection
Presence of any other active or suspected acute or chronic uncontrolled infection
Severe cardiac insufficiency, with uncontrolled and/or unstable cardiac or coronary artery disease
History of another malignancy within 5 years prior to study entry, except for curatively treated non-melanotic skin cancer or cervical cancer in situ
Other protocol-defined inclusion/exclusion criteria may apply.