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

• Sponsor: Astellas Pharma Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00818480
• Collaborator: (none)
• Enrollment: 10
• Locations: 3
• Arm: 1
• Duration (Months): 78
• Patients Per Site: 3.3
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer; Melanoma; Non-Hodgkin's Lymphoma	Drug: YM155	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Feb 1, 2006
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Assess Response Rate [End of Study up to 77 months]

2. Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs) [End of Study up to 77 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Institute for Drug Development	San Antonio	Texas	United States	78229
2	South Texas Accelerated	San Antonio	Texas	United States	78229
3	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Astellas Pharma Inc
• ClinicalTrials.gov Identifier: NCT00818480
• Other Study ID Numbers: 155-CL-101
• First Posted: Jan 7, 2009
• Last Update Posted: Sep 4, 2015
• Last Verified: Aug 1, 2015

• Keywords provided by Astellas Pharma Inc: prostate cancer; melanoma; lymphoma; YM155
• Additional relevant MeSH terms: Prostatic Neoplasms; Melanoma

Study Results

No Results Posted as of Sep 4, 2015