Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer
AG-013736 (AXITINIB) FOR THE TREATMENT OF METASTATIC RENAL CELL CANCER
2 other identifiers
interventional
492
14 countries
125
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2009
Longer than P75 for phase_3
125 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2009
CompletedFirst Posted
Study publicly available on registry
June 15, 2009
CompletedStudy Start
First participant enrolled
August 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 27, 2012
CompletedResults Posted
Study results publicly available
February 4, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 29, 2021
CompletedMay 6, 2022
April 1, 2022
2.9 years
June 11, 2009
July 26, 2013
April 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression Free Survival (PFS): First-Line Participants
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.
Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)
Progression Free Survival (PFS): Second-Line Participants
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.
Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)
Secondary Outcomes (6)
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 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)
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)
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)
Overall Survival (OS): First-Line Participants
Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)
- +1 more secondary outcomes
Other Outcomes (8)
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants
Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants
Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants
Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)
- +5 more other outcomes
Study Arms (2)
A
EXPERIMENTALB
ACTIVE COMPARATORInterventions
axitinib will be given at a starting dose of 5 mg BID with continuous dosing
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (125)
Advanced Medical Specialties
Miami, Florida, 33143, United States
Advanced Medical Specialties
Miami, Florida, 33176, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, 60005, United States
Illinois Cancer Specialists
Niles, Illinois, 60714, United States
Indiana University Health Central Indiana Cancer Centers
Carmel, Indiana, 46032, United States
Indiana University Health Central Indiana Cancer Centers
Fishers, Indiana, 46037, United States
Indiana University Health Central Indiana Cancer Centers
Greenfield, Indiana, 46140, United States
Indiana University Health Central Indiana Cancer Centers
Indianapolis, Indiana, 46219, United States
Indiana University Health Central Indiana Cancer Centers
Indianapolis, Indiana, 46227, United States
Missouri Cancer Associates
Columbia, Missouri, 65201, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89052, United States
US Oncology West Region
Henderson, Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89074, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89128, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, United States
Hematology-Oncology Associates of Northern NJ, PA
Morristown, New Jersey, 07962, United States
Hematology-Oncology Associates of Northern NJ, PA
Parsippany, New Jersey, 07054, United States
New York Oncology Hematology, PC
Albany, New York, 12206, United States
New York Oncology Hematology, PC
Albany, New York, 12208, United States
New York Oncology Hematology, PC
Latham, New York, 12110, United States
New York Oncology Hematology, PC
Rexford, New York, 12148, United States
New York Oncology Hematology, PC
Troy, New York, 12180, United States
Raleigh Hematology Oncology Associates
Cary, North Carolina, 27518, United States
Raleigh Hematology Oncology Associates
Raleigh, North Carolina, 27607, United States
Raleigh Hematology Oncology Associates
Raleigh, North Carolina, 27614, United States
Northwest Cancer Specialists, PC
Portland, Oregon, 97213, United States
Northwest Cancer Specialists, PC
Portland, Oregon, 97225, United States
Northwest Cancer Specialists, PC
Portland, Oregon, 97227, United States
Northwest Cancer Specialists, PC
Tualatin, Oregon, 97062, United States
Penn State Milton S. Hershey Medical Center, Penn State Cancer Institute
Hershey, Pennsylvania, 17033-0850, United States
Medical University of South Carolina University Hospital
Charleston, South Carolina, 29425, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Texas Oncology- Amarillo
Amarillo, Texas, 79106, United States
Texas Oncology-Beaumont, Mamie McFaddin Ward Cancer Center
Beaumont, Texas, 77702-1449, United States
Texas Oncology- Bedford
Bedford, Texas, 76022, United States
Texas Oncology- Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
Texas Oncology- Fort Worth 12th Avenue
Fort Worth, Texas, 76104, United States
Texas Oncology- Southwest Fort Worth
Fort Worth, Texas, 76132, United States
Investigational Products Center (lPC)
Fort Worth, Texas, 76177, United States
US Oncology Research and Clinical Pharmacy
Fort Worth, Texas, 76177, United States
Texas Oncology - Grapevine
Grapevine, Texas, 76051, United States
Cancer Care Centers of South Texas
Kerrville, Texas, 78028, United States
Texas Oncology- McAllen South Second Street
McAllen, Texas, 78503, United States
Texas Oncology- Midland Allison Cancer Center
Midland, Texas, 79701, United States
Cancer Care Centers of South Texas
San Antonio, Texas, 78217, United States
Cancer Care Centers of South Texas
San Antonio, Texas, 78258-3912, United States
Texas Oncology-Deke Slayton Cancer Center
Webster, Texas, 77598-4420, United States
Texas Oncology-Weslaco
Weslaco, Texas, 78596, United States
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Christiansburg, Virginia, 24073, United States
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Low Moor, Virginia, 24457, United States
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Roanoke, Virginia, 24014, United States
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Salem, Virginia, 24153, United States
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Wytheville, Virginia, 24382, United States
Northwest Cancer Specialists, PC
Vancouver, Washington, 98684, United States
Northwest Cancer Specialists, PC
Vancouver, Washington, 98686, United States
Wenatchee Valley Medical Center
Wenatchee, Washington, 98801, United States
Clinic of Oncology
Banja Luka, 78000, Bosnia and Herzegovina
Institute of Oncology, University Hospital Center Sarajevo
Sarajevo, 71000, Bosnia and Herzegovina
University Clinical Center Tuzla, Clinic for Oncology, Hematology and Radiotherapy
Tuzla, 75000, Bosnia and Herzegovina
Spetsializirana Bolnitsa za Aktivno Lechenie po Onkologiya, EAD, Klinika po Himioterapiya
Sofia, 1756, Bulgaria
SBALOZ D-r Marko Markov-Varna
Varna, 9000, Bulgaria
Instituto Clinico Oncologico del Sur
Temuco, Cautin, 4810469, Chile
Instituto Clinico Oncologico del Sur
Temuco, Región de la Araucanía, 4810561, Chile
Instituto de Terapias Oncologicas Providencia
Providencia, Santiago Metropolitan, 7501088, Chile
Private Office
Santiago, RM 8360160, Chile
Cancer Institute and Hospital ,Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Chinese PLA General Hospital
Haidian District, Beijing Municipality, 100853, China
The Fuzhou General Hospital, PLA Nanjing Military Area Command
Fuzhou, Fujian, 350025, China
Urology Department, Sun Yet-Sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Nanfang Hospital
Guangzhou, Guangdong, 510515, China
Nanjing Bayi Hospital
Nanjing, Jiangsu, 210002, China
The Oncology Department, Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
Jilin Provincial Cancer Hospital
Changchun, Jilin, 130012, China
Urology Department, 1st Hospital of China Medical University
Shenyang, Liaoning, 110001, China
Xijing Hospital, The Fourth Military Medical University,Oncology Department
Xi'an, Shaanxi, 710032, China
Urology Department, Renji Hospital,Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University, Center for Oncology
Hangzhou, Zhejiang, 310016, China
Department of Urology,Peking University First Hospital
Beijing, 100034, China
Beijing Cancer Hospital/Department of Renal Cancer and Melanoma
Beijing, 100036, China
South-Western Hospital, 3rd Military Medical University
Chongqing, 400038, China
Jiangsu Cancer Hospital
Nanjing, 210009, China
Fudan University, Cancer Hospital, Department of Urology
Shanghai, 200032, China
Tianjin Oncology Hospital,biology treatment department
Tianjin, 300060, China
Urology Department, The Second Hospital of Tianjin Medical University
Tianjin, 300211, China
BIBI General Hospital and Cancer Centre,
Hyderabad, Andhra Pradesh, 500024, India
Chinmaya Mission Hospital
Bangalore, Karnataka, 560038, India
Sri Venkateshwara Hospital
Bangalore, Karnataka, 560068, India
NU Hospitals
Bangalore, Karnataka, 560070, India
Cancer Care Clinic and Hospitals
Nagpur, Maharashtra, 440012, India
Shatabdi Superspeciality Hospital
Nashik, Maharashtra, 422 005, India
Curie Manavata Cancer Centre
Nashik, Maharashtra, 422004, India
Deenanath Mangeshkar Hospital and Research Centre
Pune, Maharashtra, 411 004, India
Sahyadri Speciality Hospital
Pune, Maharashtra, 411 004, India
Shettys hospital
Bangalore, 560068, India
University Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Hospital General de Mexico O.D.
Mexico City, Mexico City, 06726, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico City, 14000, Mexico
Centro Hemato-Oncologico Privado
Toluca, State of Mexico, 50080, Mexico
Centenario Hospital Miguel Hidalgo
Aguascalientes, 20000, Mexico
Oaxaca Site Management Organization
Oaxaca City, 68000, Mexico
Rm. 3227 Doctors Clinic, Annex II Bldg., National Kidney & Transplant Institute
Quezon City, Diliman, Philippines
St. Lukes Medical Center
Quezon City, National Capital Region, 1102, Philippines
University of the East Ramon Magsaysay Memorial Medical Center
Quezon City, National Capital Region, 1113, Philippines
Makati Medical Center
Makati City, 1200, Philippines
Room 805, Committee on Research Room, Manila Doctors Hospital
Manila, 1000, Philippines
Oncomed SRL
Timișoara, JUD. Timis, 300239, Romania
Institutul Oncologic "Prof.Dr.I.Chiricuta" Cluj-Napoca
Cluj-Napoca, 400015, Romania
Institutul Oncologic ''Prof.Dr. I. Chiricuta'' Cluj Napoca
Cluj-Napoca, 400015, Romania
GBU RO "Ryazan Regional Clinical Oncology Dispensary"
Ryazan, Russian Federation, 390011, Russia
FGBOU VO "Ryazan State Medical University named after academician I.P.Pavlov"
Ryazan, Russian Federation, 390026, Russia
Moscow State Healthcare Institution Oncology Clinical Dispensary #1
Moscow, 105005, Russia
P.A. Herzen Moscow Oncology Research Institute,
Moscow, 125284, Russia
FGBOU VO "First Saint-Petersburg State Medical University n.a. I.P.Pavlov"
Saint Petersburg, 197022, Russia
Republican Clinical Oncology Dispensary of the Ministry of Health of Bashkortostan Republic
Ufa, 450054, Russia
GVI Oncology
Port Elizabeth, 6045, South Africa
Taichung Veterans General Hospital
Taichung, 407, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
KP Dnipropetrovska oblasna klinichna likarnia im. I.I. Mechnykova" Dnipropetrovskoi oblasnoi rady,
Dnipro, 49005, Ukraine
Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady Oblasnyi medychnyi klinichnyi tsentr
Kharkiv, 61037, Ukraine
DU Instytut Urolohii NAMN Ukrainy, viddil onkourolohii, KNP Kyivskyi miskyi klinichnyi onkolohichnyi
Kyiv, 03115, Ukraine
Komunalne nekomertsiine pidpryiemstvo Lvivskoi oblasnoi rady Lvivskyi onkolohichnyi rehionalnyi
Lviv, 79031, Ukraine
SI "Zaporizhzhya Medical Academy of Postgraduate Education of the Ministry of Health of Ukraine"
Zaporizhzhya, 69040, Ukraine
Related Publications (8)
Rini BI, Atkins MB, Choueiri TK, Teresi RE, Rosbrook B, Thakur M, Hutson TE. Plain language summary looking at how long side effects last after treatment with axitinib is stopped in people with advanced renal cell carcinoma. Future Oncol. 2023 Dec;19(40):2623-2629. doi: 10.2217/fon-2023-0233. Epub 2023 Aug 1.
PMID: 37526095DERIVEDAldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.
PMID: 37146227DERIVEDRini BI, Atkins MB, Choueiri TK, Thomaidou D, Rosbrook B, Thakur M, Hutson TE. Time to Resolution of Axitinib-Related Adverse Events After Treatment Interruption in Patients With Advanced Renal Cell Carcinoma. Clin Genitourin Cancer. 2021 Oct;19(5):e306-e312. doi: 10.1016/j.clgc.2021.03.019. Epub 2021 Apr 5.
PMID: 33947608DERIVEDde Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.
PMID: 28410911DERIVEDHutson TE, Al-Shukri S, Stus VP, Lipatov ON, Shparyk Y, Bair AH, Rosbrook B, Andrews GI, Vogelzang NJ. Axitinib Versus Sorafenib in First-Line Metastatic Renal Cell Carcinoma: Overall Survival From a Randomized Phase III Trial. Clin Genitourin Cancer. 2017 Feb;15(1):72-76. doi: 10.1016/j.clgc.2016.05.008. Epub 2016 May 27.
PMID: 27498023DERIVEDGrunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.
PMID: 27238653DERIVEDQin S, Bi F, Jin J, Cheng Y, Guo J, Ren X, Huang Y, Tarazi J, Tang J, Chen C, Kim S, Ye D. Axitinib versus sorafenib as a second-line therapy in Asian patients with metastatic renal cell carcinoma: results from a randomized registrational study. Onco Targets Ther. 2015 Jun 8;8:1363-73. doi: 10.2147/OTT.S83302. eCollection 2015.
PMID: 26089686DERIVEDHutson TE, Lesovoy V, Al-Shukri S, Stus VP, Lipatov ON, Bair AH, Rosbrook B, Chen C, Kim S, Vogelzang NJ. Axitinib versus sorafenib as first-line therapy in patients with metastatic renal-cell carcinoma: a randomised open-label phase 3 trial. Lancet Oncol. 2013 Dec;14(13):1287-94. doi: 10.1016/S1470-2045(13)70465-0. Epub 2013 Oct 25.
PMID: 24206640DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The objective of the statistical analysis for secondary endpoints was to summarize data using descriptive statistics without performing any hypothesis testing. Safety analysis did not include data from all China participants due to inability to obtain timely approval to use data in accordance to HGRAC regulations.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2009
First Posted
June 15, 2009
Study Start
August 25, 2009
Primary Completion
July 27, 2012
Study Completion
April 29, 2021
Last Updated
May 6, 2022
Results First Posted
February 4, 2014
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.