- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00372853
Dose-Finding Study Of CP-675,206 And SU011248 In Patients With Metastatic Renal Cell Carcinoma
June 5, 2012 updated by: AstraZeneca
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
This study will determine the highest tolerable dose of CP-675,206 when given in combination with SU011248.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Scottsdale, Arizona, United States, 85258
- Research Site
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New Jersey
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New Brunswick, New Jersey, United States, 08903
- Research Site
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Ohio
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Cleveland, Ohio, United States, 44195
- Research Site
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South Carolina
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Greenville, South Carolina, United States, 29605
- Research Site
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Tennessee
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Memphis, Tennessee, United States, 38120
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Arm A
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CP-675,206 administered intravenously every 3 months.
Escalating doses from 6mg/kg to 15mg/kg will be tested.
SU011248 administered at a dose of 37.5mg/day every day.
SU011248 administered at a dose of 50mg/day for 4 weeks followed by 2 weeks off, repeated every 6 weeks.
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Experimental: Arm B
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CP-675,206 administered intravenously every 3 months.
Escalating doses from 6mg/kg to 15mg/kg will be tested.
SU011248 administered at a dose of 37.5mg/day every day.
SU011248 administered at a dose of 50mg/day for 4 weeks followed by 2 weeks off, repeated every 6 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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6 weeks after first dose
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To allow for the possibility of genotyping should an unexpected outcome or an increase in unexplained adverse events be reported
Time Frame: 18 months
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18 months
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To evaluate the pharmacokinetics (PK) of CP-675,206 and SU011248 when given in combination
Time Frame: up to 18 months
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up to 18 months
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To monitor for an antibody response to CP-675,206
Time Frame: up to 18 months
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up to 18 months
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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
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6-18 months after last subject enrolled
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2006
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
September 5, 2006
First Submitted That Met QC Criteria
September 5, 2006
First Posted (Estimate)
September 7, 2006
Study Record Updates
Last Update Posted (Estimate)
June 6, 2012
Last Update Submitted That Met QC Criteria
June 5, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Carcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Immune Checkpoint Inhibitors
- Sunitinib
- Tremelimumab
- Ipilimumab
Other Study ID Numbers
- A3671025
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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