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

Novartis

Status and phase: Completed; Phase 1

Conditions: Tumors; Advanced Malignancies

Treatments: Drug: Patupilone/EPO906

Study type: Interventional

Funder types: Industry

Identifiers

NCT00420524

CEPO906A2121

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

Arm A (Normal liver function)

Experimental group

Treatment:

Drug: Patupilone/EPO906

Arm B (Mild liver dysfunction)

Experimental group

Treatment:

Drug: Patupilone/EPO906

Arm C (Moderate liver dysfunction)

Experimental group

Treatment:

Drug: Patupilone/EPO906