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

NCT ID: NCT00281541

Last Updated: 2012-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-06-30

Brief Summary

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

Detailed Description

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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

Conditions

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Melanoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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YM155

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma US, Inc.

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Principal Investigators

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D. Buell, MD

Role: STUDY_DIRECTOR

Astellas Pharma US, Inc.

Locations

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Tuscon, Arizona, United States

Site Status

Little Rock, Arkansas, United States

Site Status

Aurora, Colorado, United States

Site Status

Washington D.C., District of Columbia, United States

Site Status

Atlanta, Georgia, United States

Site Status

Montclair, New Jersey, United States

Site Status

Winston-Salem, North Carolina, United States

Site Status

Pittsburgh, Pennsylvania, United States

Site Status

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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155-CL-008

Identifier Type: -

Identifier Source: org_study_id

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