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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Carcinoma, Renal Cell

Treatments: Drug: SU011248; Drug: CP-675,206

Study type: Interventional

Funder types: Industry

Identifiers

NCT00372853

A3671025

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Arm A

Experimental group

Treatment:

Drug: SU011248

Drug: SU011248

Drug: CP-675,206

Drug: CP-675,206

Arm B

Experimental group

Treatment:

Drug: SU011248

Drug: SU011248

Drug: CP-675,206

Drug: CP-675,206