A Clinical Pharmacological Study of YM155 After Intravenous Infusion in Patients With Advanced Cancer

Study Overview
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Brief Summary
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This study investigates the pharmacokinetics of YM155, identifies the metabolic profile of YM155 and evaluates the safety and tolerability of YM155 after a 3-hour infusion in patients with advanced cancer

Official Title
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A Clinical Pharmacological Study to Assess the Distribution, Metabolism, and Elimination of YM155 After i.v. Infusion in Patients With Advanced Cancer

Conditions
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Cancer

Intervention / Treatment
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* Drug: YM155


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with histologically or cytologically confirmed locally advanced or metastatic solid tumors or non-Hodgkin's lymphomas for which YM155 has the potential, based on preclinical and/or clinical data, to show efficacy, namely: castrate resistant prostate cancer non-small cell lung cancer metastatic melanoma muscle invasive bladder cancer follicular lymphoma diffuse large B-cell lymphoma Life expectancy ≥ 3 months; and Performance status (PS) ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale at baseline Exclusion Criteria: Radiotherapy, major surgery, hormonal therapy, and chemotherapy within 4 weeks prior to the first dose of study medication and 6 weeks in the case of mitomycin-C or nitrosourea Previous therapy with YM155 Patients with renal, hepatic or colorectal cancers Inadequate bone marrow, renal and/or hepatic function History of being treated for other malignancy within 5 years except for treated basal or squamous cell carcinoma of the skin Participation in any clinical study within 4 weeks prior to start of the first dose of study medication Known brain or leptomeningeal metastases Active uncontrolled systemic infection at baseline

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: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: YM155|I.V.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the pharmacokinetics, in particular the routes and extent of metabolism and excretion, of YM155 after a 3-hour infusion |  | Day -1 up to and including Day of discharge (Day 11) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify the metabolic profile of YM155 |  | Day -1 up to and including Day of discharge (Day 11) | 
| To evaluate the safety and tolerability of YM155 through vital signs, laboratory analysis, adverse events, physical exams, ECOG performance status and echo-cardiography |  | Screening (Day -21 to -2), Day -1 up to and including Day of discharge (Day 11) and end of study visit (7-14 weeks after discharge) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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YM155, Mass-balance, Phase I, Pharmacokinetics