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A SU011248 Expanded Access Protocol for Systemic Therapy of Patients With Metastatic Renal Cell Carcinoma Who Are Ineligible for Participation in Other SU011248 Protocols But May Derive Benefit From Treatment With SU011248

This study is currently recruiting participants.
Verified December 2011 by King Faisal Specialist Hospital & Research Center
Sponsor:
Information provided by (Responsible Party):
King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier:
NCT00531544
First received: September 17, 2007
Last updated: December 10, 2011
Last verified: December 2011
History of Changes
  Purpose

A SU011248 expanded access protocol for systemic therapy of patients with metastatic Renal Cell Carcinoma who are ineligible for participation in other SU011248 protocols but may derive benefit from treatment with SU011248


Condition Intervention
Metastatic Renal Cell Carcinoma
 Drug: SU011248

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A SU011248 Expanded Access Protocol for Metastatic RCC Patients Who Are Ineligible for Participation in Other SU011248 Protocols But May Derive Benefit From Treatment With SU011248

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by King Faisal Specialist Hospital & Research Center:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 2001-2012 ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: February 2007
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: SU011248
    SU011248 Expanded Access Protocol for Systemic Therapy
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with metastatic Renal Cell Carcinoma who are ineligible for participation in other SU011248 protocols but may derive benefit from treatment with SU011248
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00531544

Contacts
Contact: Shouki Bazarbashi, MD 966-1-4647272 ext 23799 bazarbashi@kfshrc.edu.sa

Locations
Saudi Arabia
KFSH&RC Recruiting
Riyadh, Saudi Arabia, 1211
Contact: Shouki Bazarbashi, MD         bazarbashi@kfshrc.edu.sa    
Sponsors and Collaborators
King Faisal Specialist Hospital & Research Center
Investigators
Principal Investigator: Shouki Bazarbashi, MD KFSH&RC, Riyadh, Saudi Arabia
  More Information

No publications provided

Responsible Party: King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier: NCT00531544     History of Changes
Other Study ID Numbers: RAC#2061 043
Study First Received: September 17, 2007
Last Updated: December 10, 2011
Health Authority: ORA: KFSH&RC, Riyadh, Saudi Arabia

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
 Urologic Diseases
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013