Safety And Effectiveness Of Daily Dosing With 37.5 mg Sunitinib Malate In Patients With Advanced Kidney Cancer - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00338884

Purpose

A phase II study to allow patients with advanced kidney cancer access to sunitinib malate treatment and to find out the good and bad effects of taking 37.5 mg sunitinib malate in a continuous daily regimen (once per day) for one year.

Condition	Intervention	Phase
Carcinoma, Renal Cell	Drug: Sunitinib malate	Phase II

MedlinePlus related topics: Cancer Kidney Cancer

Drug Information available for: Sunitinib Sunitinib malate Malic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Efficacy And Safety Study Of Sunitinib Malate (SU011248) Administered In A Continuous Daily Regimen In Patients With Advanced (First-Line) Renal Cell Cancer

Further study details as provided by Pfizer:

Primary Outcome Measures:

To evaluate the anti-tumor activity of sunitinib malate in first-line metastatic RCC when administered in a continuous treatment regimen [ Time Frame: duration of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate patient reported outcomes (PROs) [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
To explore the correlations of potential biomarkers with clinical outcomes [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
To evaluate the safety and tolerability of sunitinib malate administered in a continuous treatment regimen [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
To evaluate time-to-tumor-progression (TTP), progression-free survival (PFS), duration of response, and the proportion of subjects alive one year after starting treatment. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
To evaluate sunitinib malate and SU012662 trough concentrations (Ctrough ) and to correlate these plasma concentrations with efficacy and safety parameters [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	September 2006
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Sunitinib malate Sunitinib malate starting dose 37.5 mg daily continuous daily schedule

Eligibility

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

Criteria

Inclusion Criteria:

Advanced kidney cancer (metastatic renal cell cancer)

Exclusion Criteria:

Previous treatment for kidney cancer, except surgical removal of kidney tumor

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00338884

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

Argentina
Pfizer Investigational Site	Active, not recruiting
Buenos Aires, Argentina, 1431
Pfizer Investigational Site	Active, not recruiting
Cordoba, Argentina, X5000AAI
Argentina, Santa Fé
Pfizer Investigational Site	Active, not recruiting
Rosario, Santa Fé, Argentina, (2000)
Australia, South Australia
Pfizer Investigational Site	Recruiting
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Pfizer Investigational Site	Recruiting
East Bentleigh, Victoria, Australia, 3165
Pfizer Investigational Site	Recruiting
Clayton, Victoria, Australia, 3168
Brazil, RS
Pfizer Investigational Site	Active, not recruiting
Porto Alegre, RS, Brazil, 90610-000
Brazil, SP
Pfizer Investigational Site	Active, not recruiting
São Paulo, SP, Brazil, 01308-050
Korea, Republic of
Pfizer Investigational Site	Active, not recruiting
Seoul, Korea, Republic of, 120-752
Pfizer Investigational Site	Active, not recruiting
Seoul, Korea, Republic of, 110-744
Mexico, Jalisco
Pfizer Investigational Site	Active, not recruiting
Guadalajara, Jalisco, Mexico, 44280
Mexico, Nuevo Leon
Pfizer Investigational Site	Active, not recruiting
Monterrey, Nuevo Leon, Mexico, 64460
Taiwan
Pfizer Investigational Site	Recruiting
Taipei, Taiwan, 112
Pfizer Investigational Site	Completed
Tainan, Taiwan, 710
Pfizer Investigational Site	Recruiting
Taichung, Taiwan, 407

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

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

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6181110
Study First Received:	June 16, 2006
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00338884
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Urogenital Neoplasms
Renal cancer
Urologic Neoplasms
Kidney cancer
Carcinoma
Urologic Diseases
Kidney Neoplasms

Sunitinib
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Antineoplastic Agents
Growth Substances
Therapeutic Uses

Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009