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: September 9, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Kidney Neoplasms
Drug: Axitinib (AG-013736)
Drug: Sorafenib
Phase 3

Study Type: Interventional
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:


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.


Enrollment: 723
Study Start Date: September 2008
Estimated Study Completion Date: July 2015
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Axitinib Drug: Axitinib (AG-013736)
axitinib will be given at a starting dose of 5 mg twice daily [BID] with continuous dosing
Active Comparator: Sorafenib Drug: Sorafenib
sorafenib will be given at a dose of 400 mg twice daily [BID] with continuous dosing

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00678392

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Locations
United States, California
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Burbank, California, United States, 91505
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Downey, California, United States, 90241
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Glendale, California, United States, 91206
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Loa Angeles, California, United States, 90095
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Los Angeles, California, United States, 90095
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Los Angeles, California, United States, 90017
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Los Angeles, California, United States, 90033
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Los Angeles, California, United States, 90057
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Montebello, California, United States, 90640
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West Covina, California, United States, 91790
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Whittier, California, United States, 90606
United States, Colorado
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Aurora, Colorado, United States, 80010
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Aurora, Colorado, United States, 80012
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Aurora, Colorado, United States, 80045
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Boulder, Colorado, United States, 80303
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Colorado Springs, Colorado, United States, 80909
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Denver, Colorado, United States, 80218
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Denver, Colorado, United States, 80220
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Lakewood, Colorado, United States, 80228
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Littleton, Colorado, United States, 80120
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Lone Tree, Colorado, United States, 80124
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Longmont, Colorado, United States, 80501
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Parker, Colorado, United States, 80138
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Thornton, Colorado, United States, 80260
United States, District of Columbia
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Washington, District of Columbia, United States, 20007
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Washington, District of Columbia, United States, 2007-2197
United States, Florida
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Bonita Springs, Florida, United States, 34135
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Bradenton, Florida, United States, 34209
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Cape Coral, Florida, United States, 33914
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Cape Coral, Florida, United States, 33990
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Deerfield Beach, Florida, United States, 33442
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Englewood, Florida, United States, 34223
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Fort Myers, Florida, United States, 33901
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Fort Myers, Florida, United States, 33916
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Fort Myers, Florida, United States, 33905
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Miami, Florida, United States, 33136
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Naples, Florida, United States, 34119
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Naples, Florida, United States, 34102
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Orlando, Florida, United States, 32806
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Port Charlotte, Florida, United States, 33980
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Ringgold, Georgia, United States, 30736
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Tyler, Texas, United States, 75702
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Webster, Texas, United States, 77598-4420
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Webster, Texas, United States, 77598
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Arlington, Virginia, United States, 22205
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Norfolk, Virginia, United States, 23502
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Virginia Beach, Virginia, United States, 23456
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Woodbridge, Virginia, United States, 22191
United States, Washington
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Seattle, Washington, United States, 98195
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Seattle, Washington, United States, 98101
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Seattle, Washington, United States, 98109-1023
Australia, Australian Capital Territory
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Garran, Australian Capital Territory, Australia, 2605
Australia, South Australia
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Kurralta Park, South Australia, Australia, 5037
Australia, Victoria
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Ballarat, Victoria, Australia, 3350
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East Melbourne, Victoria, Australia, 3002
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Heidelberg, Victoria, Australia, 3084
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Heidelberg West, Victoria, Australia, 3081
Austria
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Wien, Austria, 1020
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Wien, Austria, A-1090
Brazil
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Rio de Janeiro, RJ, Brazil, 22260-020
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Porto Alegre, RS, Brazil, 90050-170
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Barretos, SP, Brazil, 14784-400
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Sao Paulo, SP, Brazil, 01509-900
Canada, Alberta
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Calgary, Alberta, Canada, T2N 4N2
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Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
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Kelowna, British Columbia, Canada, V1Y 5L3
Canada, New Brunswick
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Moncton, New Brunswick, Canada, E1C 8X3
Canada, Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario
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Oshawa, Ontario, Canada, L1G 2B9
China, Jiangsu
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Nanjing, Jiangsu, China, 210002
China, Shaanxi
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Xi'an, Shaanxi, China, 710032
China
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Beijing, China, 100021
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Beijing, China, 100036
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Guangzhou, China, 510060
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Shanghai, China, 200127
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Tianjin, China, 300060
France
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Lyon, Cedex 08, France, 69373
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Bordeaux Cedex, France, 33075
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CRETEIL Cedex, France, 94010
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Marseille Cedex 09, France, 13273
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Paris Cedex 15, France, 75908
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Rennes, France, 35042
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St Herblain Cedex, France, 44805
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Tours Cedex 1, France, 37044
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Vandoeuvre les Nancy, France, 54511
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Villejuif Cedex, France, 94805
Germany
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Aachen, Germany, 52074
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Berlin, Germany, 12200
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Essen, Germany, 45122
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Hannover, Germany, 30449
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Mainz, Germany, 55131
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Muenchen, Germany, 81377
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Oldenburg, Germany, 26133
Greece
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Athens, Attiki, Greece, 115 28
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Thessaloniki, Macedonia, Greece, 540 07
India
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New Delhi, Delhi, India, 110 029
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Kochi, Kerala, India, 682 026
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Mumbai, Maharashtra, India, 400012
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Ludhiana, Punjab, India, 141 008
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Jaipur, Rajasthan, India, 302017
Ireland
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Dublin 24, Ireland
Italy
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Arezzo, Italy, 52100
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Aviano, Italy, 33081
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Aviano (PN), Italy, 33081
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Brescia, Italy, 25123
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Cremona, Italy, 26100
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Genova, Italy, 16132
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Milano, Italy, 20133
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Napoli, Italy, 80131
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Padova, Italy, 35128
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Pavia, Italy, 27100
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Roma, Italy, 00152
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Roma, Italy, 00144
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Rozzano (MI), Italy, 20089
Japan
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Sapporo, Hokkaido, Japan
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Tsukuba, Ibaraki, Japan
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Osakasayama, Osaka, Japan
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Hamamatsu-City, Shizuoka, Japan
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Sunto-gun, Shizuoka, Japan
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Arakawa-ku, Tokyo, Japan
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Chuo-Ku, Tokyo, Japan
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Itabashi-ku, Tokyo, Japan
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Shinjuku-ku, Tokyo, Japan
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Ube-shi, Yamaguchi, Japan
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Akita, Japan
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Chiba, Japan
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Fukuoka, Japan
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Kumamoto, Japan
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Tokushima, Japan
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Yamagata, Japan
Korea, Republic of
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Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
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Busan, Korea, Republic of, 602-715
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Seoul, Korea, Republic of, 137-701
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Seoul, Korea, Republic of, 110-744
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Seoul, Korea, Republic of, 135-710
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Seoul, Korea, Republic of, 120-752
Poland
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Gdansk, Poland, 80-210
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Poznan, Poland, 61-878
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Warszawa, Poland, 00-909
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Wroclaw, Poland, 50-556
Russian Federation
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Obninsk, Kaluga region, Russian Federation, 249036
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Moscow, Russian Federation, 125284
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Moscow, Russian Federation, 117997
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Moscow, Russian Federation, 123060
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Moscow, Russian Federation, 115478
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St. Petersburg, Russian Federation, 198255
Singapore
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Singapore, Singapore, 169610
Slovakia
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Bratislava, Slovakia, 833 10
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Bratislava, Slovakia, 812 50
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Zilina, Slovakia, 012 07
Spain
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L'hospitalet de Llobregat, Barcelona, Spain, 08907
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Pamplona, Navarra, Spain, 31008
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Barcelona, Spain, 08035
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Madrid, Spain, 28041
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Madrid, Spain, 28034
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Malaga, Spain, 29010
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Sevilla, Spain, 41009
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Zaragoza, Spain, 50009
Sweden
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Linkoping, Sweden, 581 85
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Umea, Sweden, 901 85
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Vaxjo, Sweden, 351 85
Taiwan
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Kaohsiung Hsien, Taiwan, 833
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Taichung, Taiwan, 407
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Taipei, Taiwan, 100
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Taoyuan, Taiwan, 333
United Kingdom
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London, England, United Kingdom, SW3 6JJ
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Northwood, Middlesex, United Kingdom, HA6 2RN
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Bebington, Wirral, United Kingdom, CH63 4JY
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Birmingham, United Kingdom, B15 2TT
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Bournemouth, United Kingdom, SO41 3QS
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Bristol, United Kingdom, BS2 8ED
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Cambridge, United Kingdom, CB2 0QQ
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Glasgow, United Kingdom, G12 0YH
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London, United Kingdom, EC1A 7BE
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Oxford, United Kingdom, OX3 7LJ
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Surrey, United Kingdom, SM2 5PT
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: NCT00678392     History of Changes
Other Study ID Numbers: A4061032, AXIS TRIAL
Study First Received: May 12, 2008
Results First Received: February 25, 2012
Last Updated: September 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Axitinib in Second Line Treatment of Patients With Metastatic Renal Cell Cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sorafenib
Axitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014