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

A Clinical Pharmacological Study to Assess the Distribution, Metabolism, and Elimination of YM155 After i.v. 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

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