Anti-angiogenesis Agent AG-013736 in Patients With Metastatic Renal Cell Carcinoma

June 20, 2012 updated by: Pfizer

Phase 2 Study of AG 013736 as Second-Line Treatment in Patients With Metastatic Renal Cell Cancer

The primary purpose of this protocol is to determine the activity of AG 013736 in patients with metastatic renal cell cancer who have received 1 prior cytokine-based therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 2

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

  • France
    • Paris
      • Paris Cedex 13, Paris, France, 75651
        • Pfizer Investigational Site
  • Germany
      • Hannover, Germany, 30625
        • Pfizer Investigational Site
  • United States
    • California
      • San Francisco, California, United States, 94115
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Pfizer Investigational Site
      • Boston, Massachusetts, United States, 02115
        • Pfizer Investigational Site
    • New York
      • New York, New York, United States, 10021
        • Pfizer Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111-2497
        • Pfizer Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Pfizer Investigational 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 documented RCC with metastases.
  • Failure of 1 prior cytokine-based therapy (interleukin-2 and/or interferon) due to disease progression or unacceptable treatment-related toxicity

Exclusion Criteria:

  • Any prior systemic treatment for Renal Cell Carcinoma [RCC] other than 1 prior cytokine-based treatment regimen. Cytokine-based regimens containing thalidomide or an anti-angiogenesis agent are not allowed.
  • Inability to take oral medication

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: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Objective Response (OR)
Time Frame: Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks
Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Disease Progression (TTP)
Time Frame: Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks
Time in days from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1). Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).
Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks
Duration of Response (DR)
Time Frame: Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks
Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1). DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks
Overall Survival (OS)
Time Frame: Baseline to death due to any cause or at least 1 year after the initial dose for the last treated participant
Time in days from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1). Death was determined from adverse event (AE) data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact.
Baseline to death due to any cause or at least 1 year after the initial dose for the last treated participant
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Time Frame: Baseline, Days 29, 57, 113, 169, 225, 281, 337, 393, 449, 505, 561, 617, 673, 729, 785, 841, 897, 953 and follow-up visit after last dose
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score.
Baseline, Days 29, 57, 113, 169, 225, 281, 337, 393, 449, 505, 561, 617, 673, 729, 785, 841, 897, 953 and follow-up visit after last dose

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Population Pharmacokinetics of Axitinib (AG-013736)
Time Frame: Day 1 (Pre-dose), Day 29, Day 57 and then every 8 weeks up to 139 weeks
Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.
Day 1 (Pre-dose), Day 29, Day 57 and then every 8 weeks up to 139 weeks

Collaborators and Investigators

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

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

October 1, 2003

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

January 12, 2004

First Submitted That Met QC Criteria

January 13, 2004

First Posted (Estimate)

January 14, 2004

Study Record Updates

Last Update Posted (Estimate)

June 26, 2012

Last Update Submitted That Met QC Criteria

June 20, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A4061012

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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