Clinical trial NCT00920816: Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer
Official title: AG-013736 (AXITINIB) FOR THE TREATMENT OF METASTATIC RENAL CELL CANCER
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Neoplasms
Keywords: Axitinib in First & Second Line Treatment of Patients With Metastatic Renal Cell Cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-06-15
Enrollment: 492
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Progression Free Survival (PFS): First-Line Participants
timeFrame: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)
measure: Progression Free Survival (PFS): Second-Line Participants
timeFrame: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)
Secondary outcomes:
measure: Percentage of Participants With Objective Response (OR): First-Line Participants
timeFrame: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)
measure: Percentage of Participants With Objective Response (OR): Second-Line Participants
timeFrame: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)
measure: Duration of Response (DR): First-Line Participants
timeFrame: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)
measure: Duration of Response (DR): Second-Line Participants
timeFrame: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)
measure: Overall Survival (OS): First-Line Participants
timeFrame: Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)
measure: Overall Survival (OS): Second-Line Participants
timeFrame: Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)
Other outcomes:
measure: Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants
timeFrame: 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)
measure: Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants
timeFrame: 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)
measure: Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants
timeFrame: 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)
measure: Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants
timeFrame: 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)
measure: Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants
timeFrame: 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)
measure: Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants
timeFrame: 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)
measure: Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants
timeFrame: 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)
measure: Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants
timeFrame: 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)
Locations:
city: Miami
country: United States
facility: Advanced Medical Specialties
state: Florida
city: Miami
country: United States
facility: Advanced Medical Specialties
state: Florida
city: Arlington Heights
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Niles
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Carmel
country: United States
facility: Indiana University Health Central Indiana Cancer Centers
state: Indiana
city: Fishers
country: United States
facility: Indiana University Health Central Indiana Cancer Centers
state: Indiana
city: Greenfield
country: United States
facility: Indiana University Health Central Indiana Cancer Centers
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Health Central Indiana Cancer Centers
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Health Central Indiana Cancer Centers
state: Indiana
city: Columbia
country: United States
facility: Missouri Cancer Associates
state: Missouri
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: Henderson
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Henderson
country: United States
facility: US Oncology West Region
state: Nevada
city: Henderson
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Morristown
country: United States
facility: Hematology-Oncology Associates of Northern NJ, PA
state: New Jersey
city: Parsippany
country: United States
facility: Hematology-Oncology Associates of Northern NJ, PA
state: New Jersey
city: Albany
country: United States
facility: New York Oncology Hematology, PC
state: New York
city: Albany
country: United States
facility: New York Oncology Hematology, PC
state: New York
city: Latham
country: United States
facility: New York Oncology Hematology, PC
state: New York
city: Rexford
country: United States
facility: New York Oncology Hematology, PC
state: New York
city: Troy
country: United States
facility: New York Oncology Hematology, PC
state: New York
city: Cary
country: United States
facility: Raleigh Hematology Oncology Associates
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Hematology Oncology Associates
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Hematology Oncology Associates
state: North Carolina
city: Portland
country: United States
facility: Northwest Cancer Specialists, PC
state: Oregon
city: Portland
country: United States
facility: Northwest Cancer Specialists, PC
state: Oregon
city: Portland
country: United States
facility: Northwest Cancer Specialists, PC
state: Oregon
city: Tualatin
country: United States
facility: Northwest Cancer Specialists, PC
state: Oregon
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center, Penn State Cancer Institute
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina University Hospital
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Amarillo
country: United States
facility: Texas Oncology- Amarillo
state: Texas
city: Beaumont
country: United States
facility: Texas Oncology-Beaumont, Mamie McFaddin Ward Cancer Center
state: Texas
city: Bedford
country: United States
facility: Texas Oncology- Bedford
state: Texas
city: Dallas
country: United States
facility: Texas Oncology- Baylor Charles A. Sammons Cancer Center
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology- Fort Worth 12th Avenue
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology- Southwest Fort Worth
state: Texas
city: Fort Worth
country: United States
facility: Investigational Products Center (lPC)
state: Texas
city: Fort Worth
country: United States
facility: US Oncology Research and Clinical Pharmacy
state: Texas
city: Grapevine
country: United States
facility: Texas Oncology - Grapevine
state: Texas
city: Kerrville
country: United States
facility: Cancer Care Centers of South Texas
state: Texas
city: McAllen
country: United States
facility: Texas Oncology- McAllen South Second Street
state: Texas
city: Midland
country: United States
facility: Texas Oncology- Midland Allison Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Cancer Care Centers of South Texas
state: Texas
city: San Antonio
country: United States
facility: Cancer Care Centers of South Texas
state: Texas
city: Webster
country: United States
facility: Texas Oncology-Deke Slayton Cancer Center
state: Texas
city: Weslaco
country: United States
facility: Texas Oncology-Weslaco
state: Texas
city: Christiansburg
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
state: Virginia
city: Low Moor
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
state: Virginia
city: Roanoke
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
state: Virginia
city: Salem
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
state: Virginia
city: Wytheville
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
state: Virginia
city: Vancouver
country: United States
facility: Northwest Cancer Specialists, PC
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists, PC
state: Washington
city: Wenatchee
country: United States
facility: Wenatchee Valley Medical Center
state: Washington
city: Banja Luka
country: Bosnia and Herzegovina
facility: Clinic of Oncology
city: Sarajevo
country: Bosnia and Herzegovina
facility: Institute of Oncology, University Hospital Center Sarajevo
city: Tuzla
country: Bosnia and Herzegovina
facility: University Clinical Center Tuzla, Clinic for Oncology, Hematology and Radiotherapy
city: Sofia
country: Bulgaria
facility: Spetsializirana Bolnitsa za Aktivno Lechenie po Onkologiya, EAD, Klinika po Himioterapiya
city: Varna
country: Bulgaria
facility: SBALOZ D-r Marko Markov-Varna
city: Temuco
country: Chile
facility: Instituto Clinico Oncologico del Sur
state: Cautin
city: Temuco
country: Chile
facility: Instituto Clinico Oncologico del Sur
state: IX Region
city: Providencia
country: Chile
facility: Instituto de Terapias Oncologicas Providencia
state: Santiago
city: Santiago
country: Chile
facility: Private Office
city: Beijing
country: China
facility: Cancer Institute and Hospital ,Chinese Academy of Medical Sciences
state: Beijing
city: Haidian District
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Fuzhou
country: China
facility: The Fuzhou General Hospital, PLA Nanjing Military Area Command
state: Fujian
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guang DONG
city: Guangzhou
country: China
facility: Urology Department, Sun Yet-Sen University Cancer Center
state: Guangdong
city: Nanjing
country: China
facility: Nanjing Bayi Hospital
state: Jiangsu
city: Nanjing
country: China
facility: The Oncology Department, Jiangsu Province Hospital
state: Jiangsu
city: Changchun
country: China
facility: Jilin Provincial Cancer Hospital
state: Jilin
city: Shen Yang
country: China
facility: Urology Department, 1st Hospital of China Medical University
state: LIAO NING
city: Xi'an
country: China
facility: Xijing Hospital, The Fourth Military Medical University,Oncology Department
state: Shaanxi
city: Shanghai
country: China
facility: Urology Department, Renji Hospital,Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University, Center for Oncology
state: Zhejiang
city: Beijing
country: China
facility: Department of Urology,Peking University First Hospital
city: Beijing
country: China
facility: Beijing Cancer Hospital/Department of Renal Cancer and Melanoma
city: Chongqing
country: China
facility: South-Western Hospital, 3rd Military Medical University
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
city: Shanghai
country: China
facility: Fudan University, Cancer Hospital, Department of Urology
city: Tianjin
country: China
facility: Tianjin Oncology Hospital,biology treatment department
city: Tianjin
country: China
facility: Urology Department, The Second Hospital of Tianjin Medical University
city: Hyderabad
country: India
facility: BIBI General Hospital and Cancer Centre,
state: Andhra Pradesh
city: Bangalore
country: India
facility: Chinmaya Mission Hospital
state: Karnataka
city: Bangalore
country: India
facility: Sri Venkateshwara Hospital
state: Karnataka
city: Bangalore
country: India
facility: NU Hospitals
state: Karnataka
city: Nagpur
country: India
facility: Cancer Care Clinic and Hospitals
state: Maharashtra
city: Nashik
country: India
facility: Shatabdi Superspeciality Hospital
state: Maharashtra
city: Nashik
country: India
facility: Curie Manavata Cancer Centre
state: Maharashtra
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital and Research Centre
state: Maharashtra
city: Pune
country: India
facility: Sahyadri Speciality Hospital
state: Maharashtra
city: Bangalore
country: India
facility: Shettys hospital
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Mexico
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
state: DF
city: Mexico City
country: Mexico
facility: Hospital General de Mexico O.D.
state: Distrito Federal
city: Toluca
country: Mexico
facility: Centro Hemato-Oncologico Privado
state: Estado DE Mexico
city: Aguascalientes
country: Mexico
facility: Centenario Hospital Miguel Hidalgo
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization
city: Quezon City
country: Philippines
facility: Rm. 3227 Doctors Clinic, Annex II Bldg., National Kidney & Transplant Institute
state: Diliman
city: Quezon City
country: Philippines
facility: St. Lukes Medical Center
state: Metro Manila
city: Quezon City
country: Philippines
facility: University of the East Ramon Magsaysay Memorial Medical Center
state: Metro Manila
city: Makati City
country: Philippines
facility: Makati Medical Center
city: Manila
country: Philippines
facility: Room 805, Committee on Research Room, Manila Doctors Hospital
city: Timisoara
country: Romania
facility: Oncomed SRL
state: JUD. Timis
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic "Prof.Dr.I.Chiricuta" Cluj-Napoca
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic ''Prof.Dr. I. Chiricuta'' Cluj Napoca
city: Moscow
country: Russian Federation
facility: Moscow State Healthcare Institution Oncology Clinical Dispensary #1
city: Moscow
country: Russian Federation
facility: P.A. Herzen Moscow Oncology Research Institute,
city: Ryazan
country: Russian Federation
facility: GBU RO "Ryazan Regional Clinical Oncology Dispensary"
city: Ryazan
country: Russian Federation
facility: FGBOU VO "Ryazan State Medical University named after academician I.P.Pavlov"
city: Saint-Petersburg
country: Russian Federation
facility: FGBOU VO "First Saint-Petersburg State Medical University n.a. I.P.Pavlov"
city: Ufa
country: Russian Federation
facility: Republican Clinical Oncology Dispensary of the Ministry of Health of Bashkortostan Republic
city: Port Elizabeth
country: South Africa
facility: GVI Oncology
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Dnipro
country: Ukraine
facility: KP Dnipropetrovska oblasna klinichna likarnia im. I.I. Mechnykova" Dnipropetrovskoi oblasnoi rady,
city: Kharkiv
country: Ukraine
facility: Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady Oblasnyi medychnyi klinichnyi tsentr
city: Kyiv
country: Ukraine
facility: DU Instytut Urolohii NAMN Ukrainy, viddil onkourolohii, KNP Kyivskyi miskyi klinichnyi onkolohichnyi
city: Lviv
country: Ukraine
facility: Komunalne nekomertsiine pidpryiemstvo Lvivskoi oblasnoi rady Lvivskyi onkolohichnyi rehionalnyi
city: Zaporizhzhya
country: Ukraine
facility: SI "Zaporizhzhya Medical Academy of Postgraduate Education of the Ministry of Health of Ukraine"
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Rini 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.
citation: de 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.
citation: Hutson 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.
citation: Grunwald 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.
citation: Qin 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.
citation: Hutson 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.