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

This study is not yet open for participant recruitment.

Verified by Pfizer, April 2009

First Received: February 2, 2009 Last Updated: April 25, 2009 History of Changes

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00835978

Purpose

Axitinib dose titration (giving a higher dose of the drug above its standard starting dose) among certain patients may improve the response to treatment.

Condition	Intervention	Phase
Carcinoma, Renal Cell	Drug: axitinib	Phase II

MedlinePlus related topics: Cancer Kidney Cancer

Drug Information available for: Axitinib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized, Double-Blind Phase 2 Study of Axitinib (AG-013736) With Or Without Dose Titration In Patients With Metastatic Renal Cell Carcinoma

Further study details as provided by Pfizer:

Primary Outcome Measures:

Overall Response Rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression Free Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Overall Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Safety Profile [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Response Duration [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Pharmacokinetics [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	May 2009
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A Randomized arm	Drug: axitinib axitinib 5mg BID (open-label) + axitinib dose titration (blinded)
B Randomized arm	Drug: axitinib axitinib 5mg BID (open-label) + placebo dose titration (blinded)
C Non-randomized arm	Drug: axitinib axitinib 5mg BID (open-label)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

metastatic renal cell carcinoma (kidney cancer) with clear cell component
no prior systemic therapy (including no prior adjuvant or neoadjuvant)
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Blood Pressure < or = 140/90mmHg

Exclusion Criteria:

brain/CNS metastasis
using more than 2 blood pressure medications

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00835978

Contacts

Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com
Contact: Pfizer CT.gov Call Center	1-800-718-1021

Locations

United States, California
Pfizer Investigational Site
Bakersfield, California, United States, 93309

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A4061046
Study First Received:	February 2, 2009
Last Updated:	April 25, 2009
ClinicalTrials.gov Identifier:	NCT00835978 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

axitinib or AG-013736 dose titration (increase) renal cell carcinoma, kidney cancer

Study placed in the following topic categories:

Urinary Tract Neoplasm
Kidney Cancer
Renal Cancer
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell

Urogenital Neoplasms
Kidney Diseases
Urologic Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell

Urogenital Neoplasms
Kidney Diseases
Urologic Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on May 07, 2009