Anti-Angiogenesis Agent AG-013736 in Patients With Metastatic Renal Cell Carcinoma - Tabular View

Tracking Information

First Received Date ^ICMJE

January 12, 2004

Last Updated Date

August 14, 2007

Start Date ^ICMJE

October 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

response rate

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00076011 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

safety profile of AG 013736
time to progression
duration of response
overall survival
explore the effects of treatment on health-related quality of life (HQoL) and the responsiveness and sensitivity of the HQoL instrument in this study population
explore pharmacokinetic correlates with response or adverse events

Original Secondary Outcome Measures ^ICMJE

safety profile of AG 013736 time to progression duration of response overall survival explore the effects of treatment on health-related quality of life (HQoL) and the responsiveness and sensitivity of the HQoL instrument in this study population explore

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Kidney Neoplasms

Intervention ^ICMJE

Drug: VEGFR and PDGFR inhibitor

Study Arms / Comparison Groups

Publications *

Rixe O, Bukowski RM, Michaelson MD, Wilding G, Hudes GR, Bolte O, Motzer RJ, Bycott P, Liau KF, Freddo J, Trask PC, Kim S, Rini BI. Axitinib treatment in patients with cytokine-refractory metastatic renal-cell cancer: a phase II study. Lancet Oncol. 2007 Nov;8(11):975-84. Epub 2007 Oct 23.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, France, Germany

Administrative Information

NCT ID ^ICMJE

NCT00076011

Responsible Party

Study ID Numbers ^ICMJE

A4061012

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

August 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP