Dose-Finding Study Of CP-675,206 And SU011248 In Patients With Metastatic Renal Cell Carcinoma
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
1 other identifier
interventional
28
1 country
5
Brief Summary
This study will determine the highest tolerable dose of CP-675,206 when given in combination with SU011248.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2006
Typical duration for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2006
CompletedFirst Posted
Study publicly available on registry
September 7, 2006
CompletedStudy Start
First participant enrolled
November 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedJune 6, 2012
June 1, 2012
3.5 years
September 5, 2006
June 5, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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
6 weeks after first dose
Secondary Outcomes (4)
To allow for the possibility of genotyping should an unexpected outcome or an increase in unexplained adverse events be reported
18 months
To evaluate the pharmacokinetics (PK) of CP-675,206 and SU011248 when given in combination
up to 18 months
To monitor for an antibody response to CP-675,206
up to 18 months
To assess any preliminary evidence of anti-tumor activity: 6-18 months after last subject enrolled
6-18 months after last subject enrolled
Study Arms (2)
Arm A
EXPERIMENTALArm B
EXPERIMENTALInterventions
CP-675,206 administered intravenously every 3 months. Escalating doses from 6mg/kg to 15mg/kg will be tested.
Eligibility Criteria
You may qualify if:
- Histologically proven renal cell carcinoma with metastases
- Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (5)
Research Site
Scottsdale, Arizona, 85258, United States
Research Site
New Brunswick, New Jersey, 08903, United States
Research Site
Cleveland, Ohio, 44195, United States
Research Site
Greenville, South Carolina, 29605, United States
Research Site
Memphis, Tennessee, 38120, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2006
First Posted
September 7, 2006
Study Start
November 1, 2006
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
June 6, 2012
Record last verified: 2012-06