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

Study Overview
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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.

Official Title
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An Open-label, Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Patupilone in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Function

Conditions
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Tumors, Advanced Malignancies

Intervention / Treatment
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* Drug: Patupilone/EPO906


Participation Criteria
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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 Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A (Normal liver function)<br> | Drug: Patupilone/EPO906<br> <br> |
| Experimental: Arm B (Mild liver dysfunction)<br> | Drug: Patupilone/EPO906<br> <br> |
| Experimental: Arm C (Moderate liver dysfunction)<br> | Drug: Patupilone/EPO906<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | at completion of the study | 
| To evaluate the preliminary anti-tumor activity which will be assessed by radiological scans every 6 weeks |  | at completion of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EPO, Patupilone, Solid Tumors