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

NCT00818480 | Completed Phase 2

• 1 other identifier: 155-CL-101
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

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.

Conditions

Prostate Cancer; Melanoma; Non-Hodgkin's Lymphoma

Keywords

prostate cancer; melanoma; lymphoma; YM155

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

1. YM155

EXPERIMENTAL

Drug: YM155

Interventions

YM155 DRUG

continuous infusion

1. YM155

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (3)

Institute for Drug Development

San Antonio, Texas, 78229, United States

Location

South Texas Accelerated

San Antonio, Texas, 78229, United States

Location

Huntsman Cancer Hospital

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Melanoma; Lymphoma, Non-Hodgkin; Lymphoma

Interventions

sepantronium

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Sr. Medical Director

  Astellas Pharma Global Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2009
• First Posted: January 7, 2009
• Study Start: February 1, 2006
• Primary Completion: March 1, 2011
• Study Completion: August 1, 2012
• Last Updated: September 4, 2015

Record last verified: 2015-08

Locations

US (3)