Study Of AG-013736 In Patients With Refractory Metastatic Renal Cell Cancer

NCT ID: NCT00282048

Last Updated: 2012-07-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2009-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To determine the activity and response rate of AG-013736 in patients with advanced and refractory renal cell cancer, (patients who also failed on sorafenib-based therapy).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Kidney Neoplasms Carcinoma, Renal Cell

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AG-013736 (axitinib)

AG-013736 single agent in continuous dosing until disease progression or unacceptable toxicity

Group Type EXPERIMENTAL

AG-013736 (axitinib)

Intervention Type DRUG

AG-013736 5 mg twice daily \[bid\] continuous dosing in 28 day cycles.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AG-013736 (axitinib)

AG-013736 5 mg twice daily \[bid\] continuous dosing in 28 day cycles.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* RCC with metastases and nephrectomy
* failure of prior sorafenib-based therapy
* at least 1 target lesion that has not been irradiated
* adequate bone marrow, hepatic and renal function, \> or equal to 18 years of age.

Exclusion Criteria

* Gastrointestinal abnormalities
* current use or inability to avoid chronic antacid therapy
* current use or anticipated inability to avoid potent CYP3A4 inhibitors or CYP1A2 inducers
* active seizure disorder or evidence of brain metastases.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Chicago, Illinois, United States

Site Status

Pfizer Investigational Site

The Bronx, New York, United States

Site Status

Pfizer Investigational Site

Cleveland, Ohio, United States

Site Status

Pfizer Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

Pfizer Investigational Site

Madison, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A4061023

Identifier Type: -

Identifier Source: org_study_id