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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00835978
First received: February 2, 2009
Last updated: September 3, 2013
Last verified: September 2013
  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 2

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

Resource links provided by NLM:


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 ]

Enrollment: 213
Study Start Date: August 2009
Estimated Study Completion Date: September 2013
Primary Completion Date: October 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

  Hide Study Locations
Locations
United States, California
Pfizer Investigational Site
Antioch, California, United States, 94531
Pfizer Investigational Site
Bakersfield, California, United States, 93309
Pfizer Investigational Site
Pleasant Hill, California, United States, 94523
Pfizer Investigational Site
San Leandro, California, United States, 94578
United States, Florida
Pfizer Investigational Site
Tampa, Florida, United States, 33612
United States, Indiana
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21201
Pfizer Investigational Site
Baltimore, Maryland, United States, 21231
Pfizer Investigational Site
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
Pfizer Investigational Site
Boston, Massachusetts, United States, 02215
United States, Michigan
Pfizer Investigational Site
Grand Rapids, Michigan, United States, 49503
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States, 63110
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68198-7680
Pfizer Investigational Site
Omaha, Nebraska, United States, 68114
United States, Nevada
Pfizer Investigational Site
Las Vegas, Nevada, United States, 89135
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45267-0502
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45219
Pfizer Investigational Site
Cleveland, Ohio, United States, 44195
Pfizer Investigational Site
Columbus, Ohio, United States, 43210
Pfizer Investigational Site
Columbus, Ohio, United States, 43221
Pfizer Investigational Site
West Chester, Ohio, United States, 45069
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States, 97239
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75246
Pfizer Investigational Site
Houston, Texas, United States, 77030
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States, 98101
Czech Republic
Pfizer Investigational Site
Brno, Czech Republic, 656 53
Pfizer Investigational Site
Olomouc, Czech Republic, 775 20
Pfizer Investigational Site
Praha 8, Czech Republic, 180 81
Pfizer Investigational Site
Usti nad Labem, Czech Republic, 401 13
Germany
Pfizer Investigational Site
Duesseldorf, Germany, 40225
Pfizer Investigational Site
Frankfurt, Germany, 60590
Pfizer Investigational Site
Hannover, Germany, 30625
Pfizer Investigational Site
Tuebingen, Germany, 72076
Pfizer Investigational Site
Weiden, Germany, 92637
Japan
Pfizer Investigational Site
Nagoya, Aichi, Japan
Pfizer Investigational Site
Sapporo, Hokkaido, Japan
Pfizer Investigational Site
Kobe, Hyogo, Japan
Pfizer Investigational Site
Osakasayama, Osaka, Japan
Pfizer Investigational Site
Hamamatsu-City, Shizuoka, Japan
Pfizer Investigational Site
Chuo-ku, Tokyo, Japan
Pfizer Investigational Site
Koto-ku, Tokyo, Japan
Pfizer Investigational Site
Shinjuku-ku, Tokyo, Japan
Pfizer Investigational Site
Akita, Japan
Pfizer Investigational Site
Chiba, Japan
Pfizer Investigational Site
Fukuoka, Japan
Pfizer Investigational Site
Nagasaki, Japan
Pfizer Investigational Site
Tokushima, Japan
Pfizer Investigational Site
Yamagata, Japan
Russian Federation
Pfizer Investigational Site
Obninsk, Kaluga region, Russian Federation, 249036
Pfizer Investigational Site
Poselok Kuzmolovskiy, Vsevolozhskiy region, Leningradskaya oblast, Russian Federation, 188663
Pfizer Investigational Site
Moscow, Russian Federation, 115478
Pfizer Investigational Site
Moscow, Russian Federation, 117997
Pfizer Investigational Site
Saint-Petersburg, Russian Federation, 198255
Pfizer Investigational Site
Saint-Petersburg, Russian Federation, 191104
Pfizer Investigational Site
Saint-Petersburg, Russian Federation, 197022
Pfizer Investigational Site
Samara, Russian Federation, 443031
Spain
Pfizer Investigational Site
Madrid, Spain, 28046
Pfizer Investigational Site
Madrid, Spain, 28007
Pfizer Investigational Site
Madrid, Spain, 28006
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00835978     History of Changes
Other Study ID Numbers: A4061046
Study First Received: February 2, 2009
Last Updated: September 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
axitinib or AG-013736 dose titration (increase) renal cell carcinoma
kidney cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014