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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Male Urogenital Diseases Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Non-Hodgkin's Lymphoma Prostatic Diseases Prostatic Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institute for Drug Development, San Antonio, Texas, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

YM155

Drug

continuous infusion

Primary outcomes

Assess Response Rate

Time frame: End of Study up to 77 months
Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)

Time frame: End of Study up to 77 months

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study 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

Important dates

Study start: 2006
Primary completion: 2011
Study completion: 2012
First posted: Jan 7, 2009
Registry last updated: Sep 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed