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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Brief Summary

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Patients who participated in the core EPO2121 study and did not clinically progress may participate in this extension protocol to further evaluate the safety, tolerability, and efficacy of patupilone.

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Detailed Description

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Conditions

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Advanced Malignancies Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A (Normal liver function)

Group Type EXPERIMENTAL

Patupilone/EPO906

Intervention Type DRUG

Arm B (Mild liver dysfunction)

Group Type EXPERIMENTAL

Patupilone/EPO906

Intervention Type DRUG

Arm C (Moderate liver dysfunction)

Group Type EXPERIMENTAL

Patupilone/EPO906

Intervention Type DRUG

Interventions

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Patupilone/EPO906

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Completion of the core study is required for participation in the extension.
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No