A Study of Patupilone in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Function

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Epothilone B; Epothilones

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.