Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer
- Registration Number
- NCT00920816
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 492
- Histologically documented metastatic renal cell cancer with a component of clear cell histology.
- Evidence of measurable disease.
- Patients with mRCC must have received no prior systemic first-line therapy or must have progressive disease per RECIST (version 1.0) after one prior systemic first line regimen for metastatic disease containing sunitinib, cytokine(s), or both.
- Prior treatment for metastatic renal cell cancer with more that one systemic first line therapy.
- Major surgery less that 4 weeks or radiation less than 2 weeks of starting study drug.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description A Axitinib (AG-013736) - B Sorafenib -
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS): First-Line Participants Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107) Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease \[PD\]), or from adverse event (AE) data (where outcome was "Death"). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is \>= 20 percent (%) increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions.
Progression Free Survival (PFS): Second-Line Participants Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103) Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease \[PD\]), or from adverse event (AE) data (where outcome was "Death"). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is \>= 20 percent (%) increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Objective Response (OR): First-Line Participants Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107) Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to 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.
Percentage of Participants With Objective Response (OR): Second-Line Participants Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103) Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to 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): First-Line Participants Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107) Time in months from the first documentation of objective tumor response that is subsequently confirmed 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 any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Duration of Response (DR): Second-Line Participants Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103) Time in months from the first documentation of objective tumor response that is subsequently confirmed 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 any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Overall Survival (OS): First-Line Participants Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107) Time in months from date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization 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).
Overall Survival (OS): Second-Line Participants Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103) Time in months from date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization 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).
Trial Locations
- Locations (96)
US Oncology West Region
🇺🇸Henderson, Nevada, United States
Nebraska Methodist Hospital
🇺🇸Omaha, Nebraska, United States
Hematology-Oncology Associates of Northern NJ, PA
🇺🇸Parsippany, New Jersey, United States
Chinmaya Mission Hospital
🇮🇳Bangalore, Karnataka, India
Shettys hospital
🇮🇳Bangalore, India
Makati Medical Center
🇵🇭Makati City, Philippines
Room 805, Committee on Research Room, Manila Doctors Hospital
🇵🇭Manila, Philippines
Oncomed SRL
🇷🇴Timisoara, JUD. Timis, Romania
University of the East Ramon Magsaysay Memorial Medical Center
🇵🇭Quezon City, Metro Manila, Philippines
P.A. Herzen Moscow Oncology Research Institute,
🇷🇺Moscow, Russian Federation
GBU RO "Ryazan Regional Clinical Oncology Dispensary"
🇷🇺Ryazan, Russian Federation
FGBOU VO "Ryazan State Medical University named after academician I.P.Pavlov"
🇷🇺Ryazan, Russian Federation
KP Dnipropetrovska oblasna klinichna likarnia im. I.I. Mechnykova" Dnipropetrovskoi oblasnoi rady,
🇺🇦Dnipro, Ukraine
Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady Oblasnyi medychnyi klinichnyi tsentr
🇺🇦Kharkiv, Ukraine
DU Instytut Urolohii NAMN Ukrainy, viddil onkourolohii, KNP Kyivskyi miskyi klinichnyi onkolohichnyi
🇺🇦Kyiv, Ukraine
SI "Zaporizhzhya Medical Academy of Postgraduate Education of the Ministry of Health of Ukraine"
🇺🇦Zaporizhzhya, Ukraine
Urology Department, 1st Hospital of China Medical University
🇨🇳Shen Yang, LIAO NING, China
Penn State Milton S. Hershey Medical Center, Penn State Cancer Institute
🇺🇸Hershey, Pennsylvania, United States
Missouri Cancer Associates
🇺🇸Columbia, Missouri, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
Texas Oncology-Beaumont, Mamie McFaddin Ward Cancer Center
🇺🇸Beaumont, Texas, United States
Advanced Medical Specialties
🇺🇸Miami, Florida, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
New York Oncology Hematology, PC
🇺🇸Troy, New York, United States
Northwest Cancer Specialists, PC
🇺🇸Vancouver, Washington, United States
Texas Oncology- Midland Allison Cancer Center
🇺🇸Midland, Texas, United States
SBALOZ D-r Marko Markov-Varna
🇧🇬Varna, Bulgaria
Medical University of South Carolina University Hospital
🇺🇸Charleston, South Carolina, United States
Texas Oncology-Weslaco
🇺🇸Weslaco, Texas, United States
Investigational Products Center (lPC)
🇺🇸Fort Worth, Texas, United States
Texas Oncology- Fort Worth 12th Avenue
🇺🇸Fort Worth, Texas, United States
Institute of Oncology, University Hospital Center Sarajevo
🇧🇦Sarajevo, Bosnia and Herzegovina
Instituto Clinico Oncologico del Sur
🇨🇱Temuco, IX Region, Chile
Cancer Care Centers of South Texas
🇺🇸San Antonio, Texas, United States
The Oncology Department, Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
Private Office
🇨🇱Santiago, Chile
NU Hospitals
🇮🇳Bangalore, Karnataka, India
Nanfang Hospital
🇨🇳Guangzhou, Guang DONG, China
Urology Department, The Second Hospital of Tianjin Medical University
🇨🇳Tianjin, China
Spetsializirana Bolnitsa za Aktivno Lechenie po Onkologiya, EAD, Klinika po Himioterapiya
🇧🇬Sofia, Bulgaria
Nanjing Bayi Hospital
🇨🇳Nanjing, Jiangsu, China
Jilin Provincial Cancer Hospital
🇨🇳Changchun, Jilin, China
Instituto de Terapias Oncologicas Providencia
🇨🇱Providencia, Santiago, Chile
Urology Department, Sun Yet-Sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
GVI Oncology
🇿🇦Port Elizabeth, South Africa
Deenanath Mangeshkar Hospital and Research Centre
🇮🇳Pune, Maharashtra, India
Department of Urology,Peking University First Hospital
🇨🇳Beijing, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
South-Western Hospital, 3rd Military Medical University
🇨🇳Chongqing, China
Xijing Hospital, The Fourth Military Medical University,Oncology Department
🇨🇳Xi'an, Shaanxi, China
BIBI General Hospital and Cancer Centre,
🇮🇳Hyderabad, Andhra Pradesh, India
Cancer Care Clinic and Hospitals
🇮🇳Nagpur, Maharashtra, India
Sri Venkateshwara Hospital
🇮🇳Bangalore, Karnataka, India
Shatabdi Superspeciality Hospital
🇮🇳Nashik, Maharashtra, India
University Malaya Medical Centre
🇲🇾Kuala Lumpur, Malaysia
Hospital General de Mexico O.D.
🇲🇽Mexico City, Distrito Federal, Mexico
Oaxaca Site Management Organization
🇲🇽Oaxaca, Mexico
Rm. 3227 Doctors Clinic, Annex II Bldg., National Kidney & Transplant Institute
🇵🇭Quezon City, Diliman, Philippines
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
🇲🇽Mexico, DF, Mexico
Centenario Hospital Miguel Hidalgo
🇲🇽Aguascalientes, Mexico
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Institutul Oncologic ''Prof.Dr. I. Chiricuta'' Cluj Napoca
🇷🇴Cluj-Napoca, Romania
St. Lukes Medical Center
🇵🇭Quezon City, Metro Manila, Philippines
Moscow State Healthcare Institution Oncology Clinical Dispensary #1
🇷🇺Moscow, Russian Federation
Republican Clinical Oncology Dispensary of the Ministry of Health of Bashkortostan Republic
🇷🇺Ufa, Russian Federation
Texas Oncology- Bedford
🇺🇸Bedford, Texas, United States
Texas Oncology- Southwest Fort Worth
🇺🇸Fort Worth, Texas, United States
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
🇺🇸Wytheville, Virginia, United States
Texas Oncology - Grapevine
🇺🇸Grapevine, Texas, United States
Texas Oncology-Deke Slayton Cancer Center
🇺🇸Webster, Texas, United States
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Komunalne nekomertsiine pidpryiemstvo Lvivskoi oblasnoi rady Lvivskyi onkolohichnyi rehionalnyi
🇺🇦Lviv, Ukraine
Indiana University Health Central Indiana Cancer Centers
🇺🇸Indianapolis, Indiana, United States
Illinois Cancer Specialists
🇺🇸Niles, Illinois, United States
Raleigh Hematology Oncology Associates
🇺🇸Raleigh, North Carolina, United States
Wenatchee Valley Medical Center
🇺🇸Wenatchee, Washington, United States
Texas Oncology- Baylor Charles A. Sammons Cancer Center
🇺🇸Dallas, Texas, United States
Texas Oncology- Amarillo
🇺🇸Amarillo, Texas, United States
Texas Oncology- McAllen South Second Street
🇺🇸McAllen, Texas, United States
US Oncology Research and Clinical Pharmacy
🇺🇸Fort Worth, Texas, United States
Clinic of Oncology
🇧🇦Banja Luka, Bosnia and Herzegovina
University Clinical Center Tuzla, Clinic for Oncology, Hematology and Radiotherapy
🇧🇦Tuzla, Bosnia and Herzegovina
Chinese PLA General Hospital
🇨🇳Haidian District, Beijing, China
Cancer Institute and Hospital ,Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
Urology Department, Renji Hospital,Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China
The Fuzhou General Hospital, PLA Nanjing Military Area Command
🇨🇳Fuzhou, Fujian, China
Beijing Cancer Hospital/Department of Renal Cancer and Melanoma
🇨🇳Beijing, China
Fudan University, Cancer Hospital, Department of Urology
🇨🇳Shanghai, China
Curie Manavata Cancer Centre
🇮🇳Nashik, Maharashtra, India
Tianjin Oncology Hospital,biology treatment department
🇨🇳Tianjin, China
Sahyadri Speciality Hospital
🇮🇳Pune, Maharashtra, India
Centro Hemato-Oncologico Privado
🇲🇽Toluca, Estado DE Mexico, Mexico
Institutul Oncologic "Prof.Dr.I.Chiricuta" Cluj-Napoca
🇷🇴Cluj-Napoca, Romania
FGBOU VO "First Saint-Petersburg State Medical University n.a. I.P.Pavlov"
🇷🇺Saint-Petersburg, Russian Federation
Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University, Center for Oncology
🇨🇳Hangzhou, Zhejiang, China
Jiangsu Cancer Hospital
🇨🇳Nanjing, China