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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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.

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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Advanced Malignancies, Tumors

Intervention / Treatment
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* Drug: Patupilone/EPO906


Participation Criteria
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Eligibility Criteria
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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.

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 |
| --- | --- | --- |
| To assess the effect of hepatic impairment on the pharmacokinetics of patupilone and its metabolite |  | After completion of the study (approximately 6 weeks from treatment) | 
| To determine the maximum tolerated dose of patupilone in patients with hepatic impairment |  | After completion of the study (approximately 6 weeks from treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To correlate the level of hepatic dysfunction to observed toxicity and pharmacokinetics |  | 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 |  | 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 |  | After completion of the study (approximately 6 weeks from treatment) | 

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