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Kidney NeoplasmsPhase 3NCT00920816

Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer

A Phase 3 study testing Axitinib (AG-013736) and Sorafenib in people with Kidney Neoplasms, run by Pfizer at 125 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Neoplasms
What is being tested?
Axitinib (AG-013736) and Sorafenib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
492 participants
Where
125 sitesin 14 countries
Study dates
25 Aug 2009to 29 Apr 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

125 sites in 14 countries.

125 sites in 14 countries

United States58 sites

  • New York Oncology Hematology, PC

    Albany, New York, 12206

  • New York Oncology Hematology, PC

    Albany, New York, 12208

  • Texas Oncology- Amarillo

    Amarillo, Texas, 79106

  • Illinois Cancer Specialists

    Arlington Heights, Illinois, 60005

  • Texas Oncology-Beaumont, Mamie McFaddin Ward Cancer Center

    Beaumont, Texas, 77702-1449

  • Texas Oncology- Bedford

    Bedford, Texas, 76022

  • Indiana University Health Central Indiana Cancer Centers

    Carmel, Indiana, 46032

  • Raleigh Hematology Oncology Associates

    Cary, North Carolina, 27518

  • Medical University of South Carolina University Hospital

    Charleston, South Carolina, 29425

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

    Christiansburg, Virginia, 24073

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • Texas Oncology- Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Indiana University Health Central Indiana Cancer Centers

    Fishers, Indiana, 46037

  • Texas Oncology- Fort Worth 12th Avenue

    Fort Worth, Texas, 76104

  • Texas Oncology- Southwest Fort Worth

    Fort Worth, Texas, 76132

  • Investigational Products Center (lPC)

    Fort Worth, Texas, 76177

  • US Oncology Research and Clinical Pharmacy

    Fort Worth, Texas, 76177

  • Texas Oncology - Grapevine

    Grapevine, Texas, 76051

  • Indiana University Health Central Indiana Cancer Centers

    Greenfield, Indiana, 46140

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89052

  • US Oncology West Region

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89074

  • Penn State Milton S. Hershey Medical Center, Penn State Cancer Institute

    Hershey, Pennsylvania, 17033-0850

  • Indiana University Health Central Indiana Cancer Centers

    Indianapolis, Indiana, 46219

  • Indiana University Health Central Indiana Cancer Centers

    Indianapolis, Indiana, 46227

  • Cancer Care Centers of South Texas

    Kerrville, Texas, 78028

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89128

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89148

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • New York Oncology Hematology, PC

    Latham, New York, 12110

  • Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

    Low Moor, Virginia, 24457

  • Texas Oncology- McAllen South Second Street

    McAllen, Texas, 78503

  • Advanced Medical Specialties

    Miami, Florida, 33143

  • Advanced Medical Specialties

    Miami, Florida, 33176

  • Texas Oncology- Midland Allison Cancer Center

    Midland, Texas, 79701

  • Hematology-Oncology Associates of Northern NJ, PA

    Morristown, New Jersey, 07962

  • Illinois Cancer Specialists

    Niles, Illinois, 60714

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Hematology-Oncology Associates of Northern NJ, PA

    Parsippany, New Jersey, 07054

  • Northwest Cancer Specialists, PC

    Portland, Oregon, 97213

  • Northwest Cancer Specialists, PC

    Portland, Oregon, 97225

  • Northwest Cancer Specialists, PC

    Portland, Oregon, 97227

  • Raleigh Hematology Oncology Associates

    Raleigh, North Carolina, 27607

  • Raleigh Hematology Oncology Associates

    Raleigh, North Carolina, 27614

  • New York Oncology Hematology, PC

    Rexford, New York, 12148

  • Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

    Roanoke, Virginia, 24014

  • Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

    Salem, Virginia, 24153

  • Cancer Care Centers of South Texas

    San Antonio, Texas, 78217

  • Cancer Care Centers of South Texas

    San Antonio, Texas, 78258-3912

  • New York Oncology Hematology, PC

    Troy, New York, 12180

  • Northwest Cancer Specialists, PC

    Tualatin, Oregon, 97062

  • Northwest Cancer Specialists, PC

    Vancouver, Washington, 98684

  • Northwest Cancer Specialists, PC

    Vancouver, Washington, 98686

  • Texas Oncology-Deke Slayton Cancer Center

    Webster, Texas, 77598-4420

  • Wenatchee Valley Medical Center

    Wenatchee, Washington, 98801

  • Texas Oncology-Weslaco

    Weslaco, Texas, 78596

  • Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

    Wytheville, Virginia, 24382

Other trials in United States

China20 sites

  • Cancer Institute and Hospital ,Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • Department of Urology,Peking University First Hospital

    Beijing, 100034

  • Beijing Cancer Hospital/Department of Renal Cancer and Melanoma

    Beijing, 100036

  • Jilin Provincial Cancer Hospital

    Changchun, Jilin, 130012

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • South-Western Hospital, 3rd Military Medical University

    Chongqing, 400038

  • The Fuzhou General Hospital, PLA Nanjing Military Area Command

    Fuzhou, Fujian, 350025

  • Urology Department, Sun Yet-Sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Nanfang Hospital

    Guangzhou, Guangdong, 510515

  • Chinese PLA General Hospital

    Haidian District, Beijing Municipality, 100853

  • Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University, Center for Oncology

    Hangzhou, Zhejiang, 310016

  • Nanjing Bayi Hospital

    Nanjing, Jiangsu, 210002

  • The Oncology Department, Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • Jiangsu Cancer Hospital

    Nanjing, 210009

  • Urology Department, Renji Hospital,Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200127

  • Fudan University, Cancer Hospital, Department of Urology

    Shanghai, 200032

  • Urology Department, 1st Hospital of China Medical University

    Shenyang, Liaoning, 110001

  • Tianjin Oncology Hospital,biology treatment department

    Tianjin, 300060

  • Urology Department, The Second Hospital of Tianjin Medical University

    Tianjin, 300211

  • Xijing Hospital, The Fourth Military Medical University,Oncology Department

    Xi'an, Shaanxi, 710032

Other trials in China

India10 sites

  • Chinmaya Mission Hospital

    Bangalore, Karnataka, 560038

  • Sri Venkateshwara Hospital

    Bangalore, Karnataka, 560068

  • NU Hospitals

    Bangalore, Karnataka, 560070

  • Shettys hospital

    Bangalore, 560068

  • BIBI General Hospital and Cancer Centre,

    Hyderabad, Andhra Pradesh, 500024

  • Cancer Care Clinic and Hospitals

    Nagpur, Maharashtra, 440012

  • Shatabdi Superspeciality Hospital

    Nashik, Maharashtra, 422 005

  • Curie Manavata Cancer Centre

    Nashik, Maharashtra, 422004

  • Deenanath Mangeshkar Hospital and Research Centre

    Pune, Maharashtra, 411 004

  • Sahyadri Speciality Hospital

    Pune, Maharashtra, 411 004

Other trials in India

Russia6 sites

  • Moscow State Healthcare Institution Oncology Clinical Dispensary #1

    Moscow, 105005

  • P.A. Herzen Moscow Oncology Research Institute,

    Moscow, 125284

  • GBU RO "Ryazan Regional Clinical Oncology Dispensary"

    Ryazan, Russian Federation, 390011

  • FGBOU VO "Ryazan State Medical University named after academician I.P.Pavlov"

    Ryazan, Russian Federation, 390026

  • FGBOU VO "First Saint-Petersburg State Medical University n.a. I.P.Pavlov"

    Saint Petersburg, 197022

  • Republican Clinical Oncology Dispensary of the Ministry of Health of Bashkortostan Republic

    Ufa, 450054

Other trials in Russia

Mexico5 sites

  • Centenario Hospital Miguel Hidalgo

    Aguascalientes, 20000

  • Hospital General de Mexico O.D.

    Mexico City, Mexico City, 06726

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Mexico City, Mexico City, 14000

  • Oaxaca Site Management Organization

    Oaxaca City, 68000

  • Centro Hemato-Oncologico Privado

    Toluca, State of Mexico, 50080

Other trials in Mexico

Philippines5 sites

  • Makati Medical Center

    Makati City, 1200

  • Room 805, Committee on Research Room, Manila Doctors Hospital

    Manila, 1000

  • Rm. 3227 Doctors Clinic, Annex II Bldg., National Kidney & Transplant Institute

    Quezon City, Diliman

  • St. Lukes Medical Center

    Quezon City, National Capital Region, 1102

  • University of the East Ramon Magsaysay Memorial Medical Center

    Quezon City, National Capital Region, 1113

Other trials in Philippines

Ukraine5 sites

  • KP Dnipropetrovska oblasna klinichna likarnia im. I.I. Mechnykova" Dnipropetrovskoi oblasnoi rady,

    Dnipro, 49005

  • Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady Oblasnyi medychnyi klinichnyi tsentr

    Kharkiv, 61037

  • DU Instytut Urolohii NAMN Ukrainy, viddil onkourolohii, KNP Kyivskyi miskyi klinichnyi onkolohichnyi

    Kyiv, 03115

  • Komunalne nekomertsiine pidpryiemstvo Lvivskoi oblasnoi rady Lvivskyi onkolohichnyi rehionalnyi

    Lviv, 79031

  • SI "Zaporizhzhya Medical Academy of Postgraduate Education of the Ministry of Health of Ukraine"

    Zaporizhzhya, 69040

Other trials in Ukraine

Chile4 sites

  • Instituto de Terapias Oncologicas Providencia

    Providencia, Santiago Metropolitan, 7501088

  • Private Office

    Santiago, RM 8360160

  • Instituto Clinico Oncologico del Sur

    Temuco, Araucania, 4810561

  • Instituto Clinico Oncologico del Sur

    Temuco, Cautin, 4810469

Other trials in Chile

Bosnia and Herzegovina3 sites

  • Clinic of Oncology

    Banja Luka, 78000

  • Institute of Oncology, University Hospital Center Sarajevo

    Sarajevo, 71000

  • University Clinical Center Tuzla, Clinic for Oncology, Hematology and Radiotherapy

    Tuzla, 75000

Other trials in Bosnia and Herzegovina

Romania3 sites

  • Institutul Oncologic "Prof.Dr.I.Chiricuta" Cluj-Napoca

    Cluj-Napoca, 400015

  • Institutul Oncologic ''Prof.Dr. I. Chiricuta'' Cluj Napoca

    Cluj-Napoca, 400015

  • Oncomed SRL

    Timișoara, JUD. Timis, 300239

Other trials in Romania

Bulgaria2 sites

  • Spetsializirana Bolnitsa za Aktivno Lechenie po Onkologiya, EAD, Klinika po Himioterapiya

    Sofia, 1756

  • SBALOZ D-r Marko Markov-Varna

    Varna, 9000

Other trials in Bulgaria

Taiwan2 sites

  • Taichung Veterans General Hospital

    Taichung, 407

  • Taipei Veterans General Hospital

    Taipei, 112

Other trials in Taiwan

Malaysia1 site

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

Other trials in Malaysia

South Africa1 site

  • GVI Oncology

    Port Elizabeth, 6045

Other trials in South Africa

About this study

Official title: AG-013736 (AXITINIB) FOR THE TREATMENT OF METASTATIC RENAL CELL CANCER

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.

Being tested
Axitinib (AG-013736), Sorafenib
Keywords
Axitinib in First & Second Line Treatment of Patients With Metastatic Renal Cell Cancer
Medical subject headings
Kidney Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Axitinib (AG-013736)Drug

    axitinib will be given at a starting dose of 5 mg BID with continuous dosing

  • SorafenibDrug

    sorafenib will be given at a dose of 400 mg BID continuous dosing

Study groups in NCT00920816
Study groupRoleWhat they receive
AExperimentalNot described
Receives: Drug: Axitinib (AG-013736)
BActive comparatorNot described
Receives: Drug: Sorafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)

  2. 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.

    Measured: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)

Secondary outcomes (6)

  1. Percentage of Participants With Objective Response (OR): First-Line Participants

    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.

    Measured: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)

  2. Percentage of Participants With Objective Response (OR): Second-Line Participants

    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.

    Measured: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)

  3. Duration of Response (DR): First-Line Participants

    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.

    Measured: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)

  4. Duration of Response (DR): Second-Line Participants

    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.

    Measured: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)

  5. Overall Survival (OS): First-Line Participants

    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).

    Measured: Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)

  6. Overall Survival (OS): Second-Line Participants

    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).

    Measured: Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2009 (estimated)
  2. Study start25 Aug 2009
  3. Primary completion27 Jul 2012
  4. Study completion29 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Masking
None (open label)
Enrolment
492 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00920816
Sponsor's protocol ID
A4061051
Other IDs
2010-018585-23
Status last verified
Apr 2022
First submitted
11 Jun 2009
Last updated
6 May 2022
Data monitoring committee
Yes
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 37526095

  • Aldin 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.

    PubMed 37146227

  • 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.

    PubMed 33947608

  • 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.

    PubMed 28410911

  • 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.

    PubMed 27498023

  • 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.

    PubMed 27238653

  • 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.

    PubMed 26089686

  • 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.

    PubMed 24206640

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Axitinib (AG-013736) and Sorafenib in people with Kidney Neoplasms, run by Pfizer at 125 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 125 sites in United States, China, India, Russia, Mexico and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS): First-Line Participants (time frame: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00920816, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2022.

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