Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00678392
First received: May 12, 2008
Last updated: July 11, 2014
Last verified: July 2014

May 12, 2008
July 11, 2014
September 2008
August 2010   (final data collection date for primary outcome measure)
Progression-Free Survival (PFS) [ Time Frame: Week 6, Week 12, every 8 weeks thereafter up to 3 years ] [ Designated as safety issue: No ]
Time in months from start of study treatment to the first documentation of objective tumor progression or to death due to any cause. PFS calculated as (Months) = (first event date minus first dose date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
Progression-Free Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00678392 on ClinicalTrials.gov Archive Site
  • Overall Survival (OS) [ Time Frame: Week 6, Week 12, every 8 weeks thereafter up to 3 years ] [ Designated as safety issue: No ]
    Overall survival was defined as the duration from assignment to study treatment to death. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact.
  • Percentage of Participants With Objective Response (OR) [ Time Frame: Week 6, Week 12, every 8 weeks thereafter up to 3 years ] [ Designated as safety issue: No ]
    Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.
  • Duration of Response (DR) [ Time Frame: Week 6, Week 12, every 8 weeks thereafter up to 3 years ] [ Designated as safety issue: No ]
    Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4.
  • Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score [ Time Frame: Baseline, Day 1 of every cycle until disease progression and Day 28 of follow-up visit (up to 670 days) ] [ Designated as safety issue: No ]
    FKSI was a questionnaire for Functional Assessment of Cancer Therapy (FACT) -Kidney Symptom Index used to assess patient-reported outcomes (PROs) for participants diagnosed with renal cell cancer. The FKSI contained 15 questions. Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Total FKSI score = sum score of the 15 item scores; total range: 0 - 60; 0 (most severe symptoms and concerns) to 60 (no symptoms or concerns).
  • FKSI-Disease Related Symptoms (FKSI-DRS) Score [ Time Frame: Baseline, Day 1 of every cycle until disease progression and Day 28 of follow-up visit (up to 670 days) ] [ Designated as safety issue: No ]
    FKSI-DRS is a subset of FKSI which is a questionnaire for FACT-Kidney Symptom Index used to assess PROs for participants diagnosed with renal cell cancer. The FKSI contained 15 questions and the FKSI-DRS consisted of 9 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI-DRS ranged between 0 to 36. Since the questions could be reversed coded, as appropriate, before calculating FKSI-DRS, 0 and 36 could be considered the worst and best health states based on the 9 questions comprising FKSI-DRS.
  • Euro Quality of Life Questionnaires- 5 Dimension (EQ-5D) Index Score [ Time Frame: Baseline, Day 1 of every cycle until disease progression and Day 28 of follow-up visit (up to 670 days) ] [ Designated as safety issue: No ]
    EQ-5D was a standardized, PRO measure of health. It provided a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index was obtained with a formula that weights each level of the dimensions. The index-based score was interpreted along a continuum of 0 (death) to 1 (perfect health).
  • EQ-5D Visual Analog Scale (EQ-5D VAS) [ Time Frame: Baseline, Day 1 of every cycle until disease progression and Day 28 of follow-up visit (up to 670 days) ] [ Designated as safety issue: No ]
    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.
  • Compare Overall Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Compare Response Rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Evaluate Safety and Tolerability on Axitinib [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Estimate the Duration of Response in Each Arm [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Compare the Kidney Specific Symptoms and Health Status [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer
Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer: Axis Trial

The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer after failure of one first line regimen.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Neoplasms
  • Drug: Axitinib (AG-013736)
    axitinib will be given at a starting dose of 5 mg twice daily [BID] with continuous dosing
  • Drug: Sorafenib
    sorafenib will be given at a dose of 400 mg twice daily [BID] with continuous dosing
  • Experimental: Axitinib
    Intervention: Drug: Axitinib (AG-013736)
  • Active Comparator: Sorafenib
    Intervention: Drug: Sorafenib

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
723
July 2015
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically confirmed renal cell cancer with a component of clear cell subtype, with metastasis
  • Evidence of measurable disease
  • Must have failed one prior systemic first-line regimen for metastatic renal cell cancer

Exclusion Criteria:

  • Prior treatment for metastatic renal cell cancer with more that one systemic first line therapy
  • Major surgery less than 4 weeks or radiation less than 2 weeks of starting study drug
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Brazil,   Canada,   China,   France,   Germany,   Greece,   India,   Ireland,   Italy,   Japan,   Korea, Republic of,   Poland,   Russian Federation,   Singapore,   Slovakia,   Spain,   Sweden,   Taiwan,   United Kingdom
 
NCT00678392
A4061032, AXIS TRIAL
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2014

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