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

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ClinicalTrials.gov Identifier: NCT01023386
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : April 13, 2010
Sponsor:
Information provided by:
Astellas Pharma Inc

Study Description
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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

Condition or disease Intervention/treatment Phase
Cancer Drug: YM155 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Clinical Pharmacological Study to Assess the Distribution, Metabolism, and Elimination of YM155 After i.v. Infusion in Patients With Advanced Cancer
Study Start Date : November 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010
Arms and Interventions
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Intervention Details:
  • Drug: YM155
    I.V.

Outcome Measures
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Primary Outcome Measures :
  1. To evaluate the pharmacokinetics, in particular the routes and extent of metabolism and excretion, of YM155 after a 3-hour infusion [ Time Frame: Day -1 up to and including Day of discharge (Day 11) ]

Secondary Outcome Measures :
  1. To identify the metabolic profile of YM155 [ Time Frame: Day -1 up to and including Day of discharge (Day 11) ]
  2. To evaluate the safety and tolerability of YM155 through vital signs, laboratory analysis, adverse events, physical exams, ECOG performance status and echo-cardiography [ Time Frame: 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) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01023386


Locations
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Hungary
Budapest, Hungary, 1122
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Chair: Use Central Contact Astellas Pharma Europe B.V.
More Information
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Responsible Party: Disclosure Office Europe, Astellas Pharma Europe BV
ClinicalTrials.gov Identifier: NCT01023386    
Other Study ID Numbers: 155-CL-005
2008-002049-21 ( Other Identifier: EudraCT )
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: April 13, 2010
Last Verified: April 2010
Keywords provided by Astellas Pharma Inc:
YM155
Mass-balance
Phase I
Pharmacokinetics