Registry for Torisel® Treated Patients With Mestatic Renal Cell Carcinoma in Usual Health Care Settings in Germany - Full Text View

Registry for Torisel® Treated Patients With Mestatic Renal Cell Carcinoma in Usual Health Care Settings in Germany (STAR-TOR)

This study is currently recruiting participants.

Verified by Wyeth, June 2008

First Received: June 13, 2008 Last Updated: June 17, 2008 History of Changes

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00700258

Purpose

The primary objective of this observational study is to describe the incidence of adverse events among patients treated with Torisel® in usual health care settings in Germany.

Condition
Renal Cell Carcinoma

Drug Information available for: CCI 779

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Evaluation of Safety, Tolerability and Activity: a Registry for Torisel® Treated Patients With Advanced or Metastatic Renal Cell Carcinoma in the Usual Health Care Setting

Further study details as provided by Wyeth:

Primary Outcome Measures:

Incidence of adverse events [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Sequence of anticancer drugs in mRCC [ Time Frame: ongoing ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	500
Study Start Date:	February 2008
Estimated Study Completion Date:	February 2013
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 patients treated with Temsirolimus under usual care settings

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Primary care

Criteria

Inclusion Criteria: - < 18 years - Males and females

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700258

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Locations

Germany
	Recruiting
Frankfurt, Germany, 60596
	Recruiting
Berlin, Germany, 10967
	Recruiting
Jena, Germany, 7743

Sponsors and Collaborators

Wyeth

Investigators

Study Director:	Medical Monitor	Wyeth
Principal Investigator:	Trial Manager	For Germany: medinfoDEU@wyeth.com

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3066K1-4407
Study First Received:	June 13, 2008
Last Updated:	June 17, 2008
ClinicalTrials.gov Identifier:	NCT00700258 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Wyeth:

non-interventional Temsirolimus Renal cell carcinoma

Study placed in the following topic categories:

Urinary Tract Neoplasm
Kidney Cancer
Renal Cancer
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell

Urogenital Neoplasms
Kidney Diseases
Urologic Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell

Urogenital Neoplasms
Kidney Diseases
Urologic Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on May 07, 2009