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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: May 31, 2013
Last verified: May 2013
History of Changes

February 2, 2009
May 31, 2013
August 2009
October 2012   (final data collection date for primary outcome measure)
Overall Response Rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00835978 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Axitinib (AG-013736) With Or Without Dose Titration (Increase) In Patients With Kidney Cancer
Randomized, Double-Blind Phase 2 Study of Axitinib (AG-013736) With Or Without Dose Titration In Patients With Metastatic Renal Cell Carcinoma

Axitinib dose titration (giving a higher dose of the drug above its standard starting dose) among certain patients may improve the response to treatment.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Carcinoma, Renal Cell
  • Drug: axitinib
    axitinib 5mg BID (open-label) + axitinib dose titration (blinded)
  • Drug: axitinib
    axitinib 5mg BID (open-label) + placebo dose titration (blinded)
  • Drug: axitinib
    axitinib 5mg BID (open-label)
  • A
    Randomized arm
    Intervention: Drug: axitinib
  • B
    Randomized arm
    Intervention: Drug: axitinib
  • C
    Non-randomized arm
    Intervention: Drug: axitinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
September 2013
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Czech Republic,   Germany,   Japan,   Russian Federation,   Spain
 
NCT00835978
A4061046
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2013

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