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

Astellas Pharma Inc0 sites6 target enrollmentNovember 2009

ConditionsCancer

DrugsYM155

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Cancer
Sponsor: Astellas Pharma Inc
Enrollment: 6
Primary Endpoint: To evaluate the pharmacokinetics, in particular the routes and extent of metabolism and excretion, of YM155 after a 3-hour infusion
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

November 2009

End Date

March 2010

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Astellas Pharma Inc

Eligibility 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

Outcomes

Primary Outcomes

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

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))