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

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Research Site
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Research Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Research Site
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Research Site
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Research Site

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
Experimental: Arm A
Drug: CP-675,206
CP-675,206 administered intravenously every 3 months. Escalating doses from 6mg/kg to 15mg/kg will be tested.
Drug: SU011248
SU011248 administered at a dose of 37.5mg/day every day.
Drug: SU011248
SU011248 administered at a dose of 50mg/day for 4 weeks followed by 2 weeks off, repeated every 6 weeks.
Experimental: Arm B
Drug: CP-675,206
CP-675,206 administered intravenously every 3 months. Escalating doses from 6mg/kg to 15mg/kg will be tested.
Drug: SU011248
SU011248 administered at a dose of 37.5mg/day every day.
Drug: SU011248
SU011248 administered at a dose of 50mg/day for 4 weeks followed by 2 weeks off, repeated every 6 weeks.

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
6 weeks after first dose

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
18 months
To evaluate the pharmacokinetics (PK) of CP-675,206 and SU011248 when given in combination
Time Frame: up to 18 months
up to 18 months
To monitor for an antibody response to CP-675,206
Time Frame: up to 18 months
up to 18 months
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
6-18 months after last subject enrolled

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

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

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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