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

Phase 2

Completed

• Conditions: Melanoma; Non-Hodgkin's Lymphoma; Prostate Cancer
• Interventions: Drug: YM155

• Registration Number: NCT00818480
• Lead Sponsor: Astellas Pharma Inc

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.

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 Timeline

• Study Start: 2006-02
• Study First Submitted: 2009-01-06
• Study First Submitted QC: 2009-01-06
• Study First Posted: 2009-01-07
• Primary Completion: 2011-03
• Study Completion: 2012-08
• Status Verified: 2015-08
• Disposition First Submitted: 2015-08-20
• Disposition First Submitted QC: 2015-08-20
• Last Update Submitted: 2015-08-20
• Disposition First Posted: 2015-09-04
• Last Update Posted: 2015-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1. YM155	YM155	-

Primary Outcome Measures

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

Trial Locations

Locations (3)

Institute for Drug Development; 🇺🇸 San Antonio, Texas, United States

South Texas Accelerated; 🇺🇸 San Antonio, Texas, United States

Huntsman Cancer Hospital; 🇺🇸 Salt Lake City, Utah, United States