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

  Show 60 Study Locations
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 22, 2014