Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: May 12, 2008
Last updated: January 5, 2014
Last verified: January 2014
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer: Axis Trial|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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").
Secondary Outcome Measures:
- 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.
|Study Start Date:||September 2008|
|Estimated Study Completion Date:||July 2015|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
Drug: Axitinib (AG-013736)
axitinib will be given at a starting dose of 5 mg twice daily [BID] with continuous dosing
|Active Comparator: Sorafenib||
sorafenib will be given at a dose of 400 mg twice daily [BID] with continuous dosing
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00678392
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Sponsors and Collaborators
|Study Director:||Pfizer CT.gov Call Center||Pfizer|