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

AstraZeneca1 site in 1 country28 target enrollmentNovember 2006

ConditionsCarcinoma, Renal Cell

InterventionsCP-675,206 SU011248

DrugsCP-675,206 SU011248

Overview

Phase: Phase 1
Intervention: CP-675,206
Conditions: Carcinoma, Renal Cell
Sponsor: AstraZeneca
Enrollment: 28
Locations: 1
Primary Endpoint: 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
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

November 2006

End Date

May 2010

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

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

Arms & Interventions

Arm A

Intervention: CP-675,206

Arm A

Intervention: SU011248

Arm B

Intervention: CP-675,206

Arm B

Intervention: SU011248

Outcomes

Primary Outcomes

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 Outcomes

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)