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

NCT ID: NCT00372853

Last Updated: 2012-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2010-05-31

Brief Summary

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

Detailed Description

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Conditions

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Carcinoma, Renal Cell

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

Group Type EXPERIMENTAL

CP-675,206

Intervention Type DRUG

CP-675,206 administered intravenously every 3 months. Escalating doses from 6mg/kg to 15mg/kg will be tested.

SU011248

Intervention Type DRUG

SU011248 administered at a dose of 37.5mg/day every day.

Arm B

Group Type EXPERIMENTAL

CP-675,206

Intervention Type DRUG

CP-675,206 administered intravenously every 3 months. Escalating doses from 6mg/kg to 15mg/kg will be tested.

SU011248

Intervention Type DRUG

SU011248 administered at a dose of 50mg/day for 4 weeks followed by 2 weeks off, repeated every 6 weeks.

Interventions

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CP-675,206

CP-675,206 administered intravenously every 3 months. Escalating doses from 6mg/kg to 15mg/kg will be tested.

Intervention Type DRUG

SU011248

SU011248 administered at a dose of 37.5mg/day every day.

Intervention Type DRUG

CP-675,206

CP-675,206 administered intravenously every 3 months. Escalating doses from 6mg/kg to 15mg/kg will be tested.

Intervention Type DRUG

SU011248

SU011248 administered at a dose of 50mg/day for 4 weeks followed by 2 weeks off, repeated every 6 weeks.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Scottsdale, Arizona, United States

Site Status

Research Site

New Brunswick, New Jersey, United States

Site Status

Research Site

Cleveland, Ohio, United States

Site Status

Research Site

Greenville, South Carolina, United States

Site Status

Research Site

Memphis, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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A3671025

Identifier Type: -

Identifier Source: org_study_id

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