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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00818480
• Other study ID #: 155-CL-101
• Status: Completed
• Phase: Phase 2
• First received: January 6, 2009
• Last updated: August 20, 2015
• Start date: February 2006
• Est. completion date: August 2012

Study information

• Verified date: August 2015
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Lymphoma, Non-Hodgkin
• Melanoma
• Non-Hodgkin's Lymphoma
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• YM155
continuous infusion

Locations

Country	Name	City	State
United States	Huntsman Cancer Hospital	Salt Lake City	Utah
United States	Institute for Drug Development	San Antonio	Texas
United States	South Texas Accelerated	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess Response Rate		End of Study up to 77 months	No
Primary	Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)		End of Study up to 77 months	No