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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00818480
First received: January 6, 2009
Last updated: September 26, 2012
Last verified: September 2012
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 ]
  • Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs) [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: February 2006
Study Completion Date: August 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. YM155 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 (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Texas
Institute for Drug Development
San Antonio, Texas, United States, 78229
South Texas Accelerated
San Antonio, Texas, United States, 78229
United States, Utah
Huntsman Cancer Hospital
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Sr. Medical Director Astellas Pharma Global Development
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00818480     History of Changes
Other Study ID Numbers: 155-CL-101
Study First Received: January 6, 2009
Last Updated: September 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
prostate cancer
melanoma
lymphoma
YM155

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Melanoma
Prostatic Neoplasms
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 22, 2014