An Extension Study Administering YM155 to Subjects Previously Enrolled in Another Protocol Administering YM155

August 20, 2015 updated by: Astellas Pharma Inc

Phase II: An Open-Label Extension Study of 168-Hour Continuous Infusion of YM155 in Subjects Previously Enrolled in a Phase I or Phase II Protocol Administering YM155

This protocol is open to subjects previously enrolled in and who had completed a Phase I or Phase II study administering YM155. Subjects who are receiving benefit from treatment with YM155 are eligible after completing the previous study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The main objective of the study is to continue to evaluate the safety and efficacy of YM155.

Each subject will be treated at the dose he/she was receiving at the completion of his/her previous phase I or phase II YM155 study.

Study Type

Interventional

Enrollment (Actual)

10

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
    • Texas
      • San Antonio, Texas, United States, 78229
        • Institute for Drug Development
      • San Antonio, Texas, United States, 78229
        • South Texas Accelerated
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Hospital

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Completed a Phase I or II YM155 study with at least stable disease and continues to meet the criteria as stated in the previous YM155 study that allows for additional treatment with YM155
  • Lack of progression based on the most recent radiological imaging, biochemical assessments and/or physical examination
  • Negative pregnancy test result (females of child-bearing potential)

Exclusion Criteria:

  • More than 21 days (or 14 days depending on the study of origin) between the time the last infusion of YM155 was stopped in the previous study and the proposed start of the first infusion in this study

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)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1. YM155
Drug: YM155
continuous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess Response Rate
Time Frame: End of Study up to 77 months
End of Study up to 77 months
Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)
Time Frame: End of Study up to 77 months
End of Study up to 77 months

Collaborators and Investigators

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

Sponsor

Astellas Pharma Inc

Investigators

  • Study Director: Sr. Medical Director, Astellas Pharma Global Development

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

February 1, 2006

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

January 6, 2009

First Submitted That Met QC Criteria

January 6, 2009

First Posted (Estimate)

January 7, 2009

Study Record Updates

Last Update Posted (Estimate)

September 4, 2015

Last Update Submitted That Met QC Criteria

August 20, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 155-CL-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Melanoma

Clinical Trials on YM155

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe