Home
Clinical Trials
Axitinib (AG 013736) As Secon...

Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer

Last Updated: 2019-01-09

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

PHASE3

Total Enrollment

723 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-03

Study Completion Date

2016-02-25

Brief Summary

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

The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer after failure of one first line regimen.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer

NCT00920816

Kidney Neoplasms

COMPLETED PHASE3

Study Of AG-013736 (Axitinib) As Second-Line Treatment In Patients With Metastatic Renal Cell Cancer (mRCC)

NCT00569946

Carcinoma, Renal Cell

COMPLETED PHASE2

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

NCT00282048

Kidney Neoplasms Carcinoma, Renal Cell

COMPLETED PHASE2

Axitinib (AG-013736) With Or Without Dose Titration (Increase) In Patients With Kidney Cancer

NCT00835978

Carcinoma, Renal Cell

COMPLETED PHASE2

Neoadjuvant Axitinib in Locally Advanced Renal Cell Carcinoma (RCC)

NCT01263769

Kidney Cancer

COMPLETED PHASE2

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

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Axitinib

Group Type EXPERIMENTAL

Axitinib (AG-013736)

Intervention Type DRUG

axitinib will be given at a starting dose of 5 mg twice daily \[BID\] with continuous dosing

Sorafenib

Group Type ACTIVE_COMPARATOR

Sorafenib

Intervention Type DRUG

sorafenib will be given at a dose of 400 mg twice daily \[BID\] with continuous dosing

Interventions

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

Axitinib (AG-013736)

axitinib will be given at a starting dose of 5 mg twice daily \[BID\] with continuous dosing

Intervention Type DRUG

Sorafenib

sorafenib will be given at a dose of 400 mg twice daily \[BID\] with continuous dosing

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* Histologically or cytologically confirmed renal cell cancer with a component of clear cell subtype, with metastasis
* Evidence of measurable disease
* Must have failed one prior systemic first-line regimen for metastatic renal cell cancer

Exclusion Criteria

* Prior treatment for metastatic renal cell cancer with more that one systemic first line therapy
* Major surgery less than 4 weeks or radiation less than 2 weeks of starting study drug

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

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.

East Valley Hematology and Oncology Medical Group

Burbank, California, United States

Site Status

Maurice Berkowtiz, MD

Burbank, California, United States

Site Status

Agajanian Institute of Oncology and Hematology

Downey, California, United States

Site Status