A Multicenter, Open-Label Study of YM155 + Docetaxel + Prednisone in Men With Advanced Hormone Refractory Prostate Cancer

This study is currently recruiting participants.

Verified by Astellas Pharma Inc, September 2008

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00514267

Purpose

To determine the feasibility and safety of administering YM155 in combination with docetaxel and prednisone in subjects with hormone refractory prostate cancer.

Condition	Intervention	Phase
Prostate Cancer	Drug: YM 155 Drug: Docetaxel Drug: Prednisone	Phase I Phase II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Prednisone Docetaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase 1 / 2 Multicenter, Open-Label Study of YM155+Docetaxel+Prednisone in Men With Advanced Hormone Refractory Prostate Cancer

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Occurrence of dose limiting toxicities [ Time Frame: 2 cycles ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Safety, pharmacokinetics and efficacy [ Time Frame: 10 cycles ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	May 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: YM 155 IV Drug: Docetaxel IV Drug: Prednisone Oral

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male subjects with histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiological evidence of metastatic disease.

Exclusion Criteria:

Radiation therapy within 4 weeks of the start of study drug

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00514267

Contacts

Contact: Astellas Pharma US Medical Information

800-888-7704 ext 5473

clintrials.info@us.astellas.com

Locations

United States, Arkansas
	Recruiting
Fort Smith, Arkansas, United States, 72901
United States, Florida
	Recruiting
Miami, Florida, United States, 33133
United States, Georgia
	Recruiting
Atlanta, Georgia, United States, 30341
United States, Texas
	Recruiting
San Antonio, Texas, United States, 78229
Contact: Central Contact
United States, Utah
	Not yet recruiting
Provo, Utah, United States, 84604

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Central Contact

Astellas Pharma US, Inc.

More Information

Responsible Party:	Astellas Pharma US, Inc ( Sr Manager Clinical Trial Registries )
Study ID Numbers:	155-CL-025
Study First Received:	August 7, 2007
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00514267
Health Authority:	United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:

Prostate Cancer
HRPC
Hormone Refractory Prostate Cancer
YM155
Treatment Outcome

Study placed in the following topic categories:

Docetaxel
Prednisone
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Neoplasms
Neoplasms by Site
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses

Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009