An Extension Study Administering YM155 to Subjects Previously Enrolled in Another Protocol Administering YM155 - Full Text View

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00818480

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer Melanoma Non-Hodgkin's Lymphoma	Drug: YM155	Phase II

MedlinePlus related topics: Cancer Lymphoma Melanoma Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Assess Response Rate [ Time Frame: End of Study ] [ Designated as safety issue: No ]
Evaluation of safety parameters [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	February 2006
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1. YM155: Experimental	Drug: YM155 continuous infusion

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00818480

Locations

United States, Texas

San Antonio, Texas, United States, 78229
United States, Utah

Salt Lake City, Utah, United States, 84112

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Use Central Contact

Astellas Pharma US, Inc.

More Information

Responsible Party:	Astellas Pharma US, Inc ( Sr Manager Clinical Trial Registry )
Study ID Numbers:	155-CL-101
Study First Received:	January 6, 2009
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00818480
Health Authority:	United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:

prostate cancer
melanoma
lymphoma
YM155

Study placed in the following topic categories:

Immunoproliferative Disorders
Prostatic Diseases
Genital Neoplasms, Male
Lymphoma, small cleaved-cell, diffuse
Urogenital Neoplasms
Genital Diseases, Male
Melanoma
Neuroendocrine Tumors
Lymphatic Diseases

Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Neuroepithelioma
Nevus
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

Immune System Diseases
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on January 16, 2009