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Completed

NCT Number: NCT01023386

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

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

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Budapest, 1122, Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

YM155

Drug

I.V.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 2, 2009
Registry last updated
Apr 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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