Back to resultsDose-Finding Study Of CP-675,206 And SU011248 In Patients With Metastatic Renal Cell Carcinoma
Primary Purpose
Carcinoma, Renal Cell
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CP-675,206
SU011248
CP-675,206
SU011248
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Renal Cell
Eligibility Criteria
Inclusion Criteria:
- Histologically proven renal cell carcinoma with metastases
- Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1
Exclusion Criteria:
- Prior treatment with more than one systemic therapy for metastatic renal cell carcinoma
- History of or known brain metastases, spinal cord compression or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease on screening Computed Axial Tomography (CT) or Magnetic Resonance Imaging (MRI) scan
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm A
Arm B
Arm Description
Outcomes
Primary Outcome Measures
To determine the highest tolerable dose of CP-675,206 that can be combined with SU011248. The safety observation period will be 6 weeks from the first dose of study drug
Secondary Outcome Measures
To allow for the possibility of genotyping should an unexpected outcome or an increase in unexplained adverse events be reported
To evaluate the pharmacokinetics (PK) of CP-675,206 and SU011248 when given in combination
To monitor for an antibody response to CP-675,206
To assess any preliminary evidence of anti-tumor activity: 6-18 months after last subject enrolled
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00372853
Brief Title
Dose-Finding Study Of CP-675,206 And SU011248 In Patients With Metastatic Renal Cell Carcinoma
Official Title
A Phase 1 Dose Escalation Trial To Evaluate The Safety And Tolerability Of CP-675,206 Administered In Combination With SU011248 To Patients With Metastatic Renal Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will determine the highest tolerable dose of CP-675,206 when given in combination with SU011248.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Renal Cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Title
Arm B
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CP-675,206
Intervention Description
CP-675,206 administered intravenously every 3 months. Escalating doses from 6mg/kg to 15mg/kg will be tested.
Intervention Type
Drug
Intervention Name(s)
SU011248
Intervention Description
SU011248 administered at a dose of 37.5mg/day every day.
Intervention Type
Drug
Intervention Name(s)
CP-675,206
Intervention Description
CP-675,206 administered intravenously every 3 months. Escalating doses from 6mg/kg to 15mg/kg will be tested.
Intervention Type
Drug
Intervention Name(s)
SU011248
Intervention Description
SU011248 administered at a dose of 50mg/day for 4 weeks followed by 2 weeks off, repeated every 6 weeks.
Primary Outcome Measure Information:
Title
To determine the highest tolerable dose of CP-675,206 that can be combined with SU011248. The safety observation period will be 6 weeks from the first dose of study drug
Time Frame
6 weeks after first dose
Secondary Outcome Measure Information:
Title
To allow for the possibility of genotyping should an unexpected outcome or an increase in unexplained adverse events be reported
Time Frame
18 months
Title
To evaluate the pharmacokinetics (PK) of CP-675,206 and SU011248 when given in combination
Time Frame
up to 18 months
Title
To monitor for an antibody response to CP-675,206
Time Frame
up to 18 months
Title
To assess any preliminary evidence of anti-tumor activity: 6-18 months after last subject enrolled
Time Frame
6-18 months after last subject enrolled
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically proven renal cell carcinoma with metastases
Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1
Exclusion Criteria:
Prior treatment with more than one systemic therapy for metastatic renal cell carcinoma
History of or known brain metastases, spinal cord compression or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease on screening Computed Axial Tomography (CT) or Magnetic Resonance Imaging (MRI) scan
Facility Information:
Facility Name
Research Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Research Site
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Research Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Research Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Dose-Finding Study Of CP-675,206 And SU011248 In Patients With Metastatic Renal Cell Carcinoma
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