Back to resultsA 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
Primary Purpose
Metastatic Renal Cell Carcinoma
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
SU011248
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Renal Cell Carcinoma
Eligibility 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
Sites / Locations
- KFSH&RC
Outcomes
Primary Outcome Measures
Efficacy
Secondary Outcome Measures
Full Information
NCT ID
NCT00531544
First Posted
September 17, 2007
Last Updated
January 4, 2016
Sponsor
King Faisal Specialist Hospital & Research Center
1. Study Identification
Unique Protocol Identification Number
NCT00531544
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King Faisal Specialist Hospital & Research Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Renal Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
350 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
SU011248
Intervention Description
SU011248 Expanded Access Protocol for Systemic Therapy
Primary Outcome Measure Information:
Title
Efficacy
Time Frame
2001-2012
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shouki Bazarbashi, MD
Organizational Affiliation
KFSH&RC, Riyadh, Saudi Arabia
Official's Role
Principal Investigator
Facility Information:
Facility Name
KFSH&RC
City
Riyadh
ZIP/Postal Code
1211
Country
Saudi Arabia
12. IPD Sharing Statement
Learn more about this trial
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
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