Dose-Finding Study Of CP-675,206 And SU011248 In Patients With Metastatic Renal Cell Carcinoma

Phase 1

Completed

• Conditions: Carcinoma, Renal Cell
• Interventions: Drug: CP-675,206; Drug: SU011248

• Registration Number: NCT00372853
• Lead Sponsor: AstraZeneca

Brief Summary

This study will determine the highest tolerable dose of CP-675,206 when given in combination with SU011248.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2006-09-05
• Study First Submitted QC: 2006-09-05
• Study First Posted: 2006-09-07
• Study Start: 2006-11
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-05
• Last Update Posted: 2012-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Histologically proven renal cell carcinoma with metastases
• Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	CP-675,206	-
Arm A	SU011248	-
Arm B	CP-675,206	-
Arm B	SU011248	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Memphis, Tennessee, United States