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

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

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
Randomized arm
Drug: axitinib
axitinib 5mg BID (open-label) + axitinib dose titration (blinded)
Randomized arm
Drug: axitinib
axitinib 5mg BID (open-label) + placebo dose titration (blinded)
Non-randomized arm
Drug: axitinib
axitinib 5mg BID (open-label)


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

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 identifier: NCT00835978

  Show 60 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Pfizer 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, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases processed this record on April 17, 2014