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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by King Faisal Specialist Hospital & Research Center.
Recruitment status was  Recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Adenocarcinoma
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Sunitinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014