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

Phase 1

Completed

• Conditions: Cancer

• Registration Number: NCT01023386
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-30
• Study First Submitted QC: 2009-11-30
• Study First Posted: 2009-12-02
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-12
• Last Update Posted: 2010-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)