A Study for the Treatment of Unresectable Stage III or Metastatic Stage IV Melanoma

June 6, 2012 updated by: Astellas Pharma Inc

A Phase II, Multicenter, Open-Label Study of YM155 in Subjects With Unresectable Stage III or Metastatic (Stage IV) Melanoma

A study with YM155 for the treatment of unresectable stage III or metastatic stage IV melanoma.

Study Overview

Status

Completed

Conditions

Melanoma

Intervention / Treatment

Drug: YM155

Detailed Description

A phase II, multicenter, open-label study in subjects with unresectable Stage III or metastatic (Stage IV) Melanoma to evaluate the efficacy and safety of YM155

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 2

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

United States
- Arizona
  - Tuscon, Arizona, United States, 85724
- Arkansas
  - Little Rock, Arkansas, United States, 72205
- Colorado
  - Aurora, Colorado, United States, 80045
- District of Columbia
  - Washington, District of Columbia, United States, 20010
- Georgia
  - Atlanta, Georgia, United States, 30322
- New Jersey
  - Montclair, New Jersey, United States, 07042
- North Carolina
  - Winston-Salem, North Carolina, United States, 27157
- Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15213
- Utah
  - Salt Lake City, Utah, United States, 84112

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:

Histologically or cytologically confirmed unresectable stage III or IV malignant melanoma
Life expectancy >12 weeks

Exclusion Criteria:

History of other malignancy in the last 5 years
Major surgery within the past 21 days

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: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Tumor response rate Time Frame: 6 cycles	6 cycles

Secondary Outcome Measures

Outcome Measure	Time Frame
Duration of response Time Frame: 6 cycles	6 cycles

Collaborators and Investigators

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

Sponsor

Astellas Pharma Inc

Collaborators

Astellas Pharma US, 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, 2005

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

January 23, 2006

First Submitted That Met QC Criteria