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

April 12, 2010 updated by: Astellas Pharma Inc

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

Study Overview

Status

Completed

Conditions

Cancer

Intervention / Treatment

Drug: YM155

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Hungary
- - Budapest, Hungary, 1122

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)	Day -1 up to and including Day of discharge (Day 11)

Secondary Outcome Measures

Outcome Measure	Time Frame
To identify the metabolic profile of YM155 Time Frame: Day -1 up to and including Day of discharge (Day 11)	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 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)	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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

November 30, 2009

First Submitted That Met QC Criteria