A Study of Trastuzumab Emtansine Versus Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Gastric Cancer
A Randomized, Multicenter, Adaptive Phase II/III Study To Evaluate The Efficacy And Safety Of Trastuzumab Emtansine (T-DM1) Versus Taxane (Docetaxel Or Paclitaxel) In Patients With Previously Treated Locally Advanced Or Metastatic HER2-Positive Gastric Cancer, Including Adenocarcinoma Of The Gastroesophageal Junction
2 other identifiers
interventional
415
28 countries
148
Brief Summary
This multicenter, randomized, adaptive Phase II/III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) compared to standard taxane (docetaxel or paclitaxel) treatment in participants with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer. At the start of the trial (stage 1), participants will be randomized with a ratio 2:2:1 to one of three treatment arms: Arm A: trastuzumab emtansine 3.6 milligram per kilogram (mg/kg) per intravenous injection (IV) every 3 weeks; Arm B: trastuzumab emtansine 2.4 mg/kg IV every week; Arm C: standard taxane therapy (docetaxel 75 milligram per meter square \[mg/m\^2\] IV every 3 weeks or paclitaxel 80 mg/m\^2 kg IV every week per investigator choice). At the end of the first stage of the study, the dose and schedule of trastuzumab emtansine that will be used in the second stage of the study will be selected by an Independent Data Monitoring Committee (IDMC). The regimen selection analysis will be made after approximately 100 participants across all three study arms have been treated for at least 12 weeks. Once a trastuzumab emtansine regimen has been selected, Stage I participants who were assigned to the treatment arm which was selected for Stage II of the study and participants who were in the standard taxane group will continue to receive their assigned treatment regimen. Stage I participants who were assigned to the regimen that was not selected for further evaluation will continue to receive their assigned regimen and will continue to be followed for efficacy and safety. In Stage II of the study, additional participants will be recruited and randomized with a ratio 2:1 to either the selected regimen of trastuzumab emtansine or to the standard taxane therapy. Participants will receive study treatment until disease progression, unacceptable toxicity, initiation of another cancer therapy or withdrawal.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 gastric-cancer
Started Sep 2012
Typical duration for phase_2 gastric-cancer
148 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
July 13, 2012
CompletedFirst Posted
Study publicly available on registry
July 17, 2012
CompletedStudy Start
First participant enrolled
September 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2016
CompletedResults Posted
Study results publicly available
August 11, 2016
CompletedMay 12, 2017
May 1, 2017
2.8 years
July 13, 2012
June 30, 2016
May 5, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Overall Survival (OS)- Phase 3
Overall survival was defined as the time between the date of randomization and date of death due to any cause. Kaplan-Meier estimates were used for analysis. Participants for whom no death was reported prior to an analysis cutoff (30 June 2015) was censored at the latest date before the cutoff in which they were known to be alive. All data from the standard taxane therapy and trastuzumab emtansine 2.4 mg (selected treatment arm) from phase 2 and phase 3 (Stage 2) are combined into phase 3 data, and thus cumulative data are provided within the results presented for phase 3. The confirmatory analyses are restricted to comparisons between the taxane arm and the selected trastuzumab emtansine arm (2.4 mg).
Date of randomization until death (up to 2 years 3 months)
Overall Survival (OS) - Phase 2 (Dose Selection Portion of the Study)
Overall survival was defined as the time between the date of randomization and date of death due to any cause. Kaplan-Meier estimates were used for analysis. Participants for whom no death was reported prior to an analysis cutoff (10 August 2013) was censored at the latest date before the cutoff in which they were known to be alive.
Date of randomization until death (up to 1 year)
Secondary Outcomes (15)
Percentage of Participants With Disease Progression or Death According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST v1.1) - Phase 3
Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months)
Progression Free Survival (PFS) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST v1.1) - Phase 3
Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months)
Percentage of Participants With Objective Response According to mRECIST v1.1 - Phase 3
Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months)
Duration of Objective Response (DOR) - Phase 3
Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months)
Percentage of Participants With Clinically Significant Improvement in European Organisation for Research and Treatment of Cancer Quality of Life Core Module 30 (EORTC QLQ-C30) Score - Phase 3
Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at follow-up (up to 2 years 3 months)
- +10 more secondary outcomes
Study Arms (3)
Standard taxane therapy
ACTIVE COMPARATORDocetaxel will be administered at 75 milligram per meter square (mg/m\^2) intravenous (IV) on Day 1 of a 21-day cycle, or paclitaxel will administered at 80 mg/m\^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) according to investigator choice until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
trastuzumab emtansine 2.4 mg
EXPERIMENTALTrastuzumab emtansine will be administered on Day 1, 8, and 15 of a 21-day cycle at 2.4 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
trastuzumab emtansine 3.6 mg
EXPERIMENTALTrastuzumab emtansine will be administered on Day 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
Interventions
Standard taxane (docetaxel 75 mg/m\^2 IV every 3 weeks or paclitaxel 80 mg/m\^2) IV once a week according to investigator choice.
trastuzumab emtansine 3.6 mg/kg IV every 3 weeks
Eligibility Criteria
You may qualify if:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 12 weeks from the first dose of study treatment
- Measurable and/or evaluable disease based on Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)
- Adequate organ function as determined by the following laboratory results, within 28 days prior to randomization
- Participants must have a history of advanced gastric cancer (AGC), defined as unresectable and locally advanced or metastatic gastric cancer, including adenocarcinoma of the gastroesophageal junction (GEJ), and must have experienced disease progression during or after first-line therapy for their disease
- HER2-positive tumor (primary tumor or metastatic lesion) as confirmed by central laboratory HER2 testing (immunohistochemistry and/or in-situ hybridization)
- Participants must have received at least one prior chemotherapy regimen for AGC; prior therapy does not need to have included HER2-directed therapy.
- First-line therapy for AGC, including adenocarcinoma of the GEJ, must have included a combination of at least a platinum- and a fluoropyrimidine-based treatment given concurrently; prior therapy does not need to have included a HER2-directed therapy.
- Adjuvant or neoadjuvant therapy for AGC is allowed.
You may not qualify if:
- An interval shorter than 21 days from the last dose of chemotherapy or HER2-directed therapy until the time of randomization
- Prior treatment with trastuzumab emtansine, docetaxel, or paclitaxel either as single agents or as part of a treatment regimen.
- Treatment with any investigational anticancer drug within 21 days of the first study treatment administration
- More than one prior line of therapy for advanced gastric cancer
- History of other malignancy within the previous 5 years except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other malignancies with an expected curative outcome
- Brain metastases that are untreated or symptomatic or require any radiation, surgery, or steroid therapy to control symptoms from brain metastases within 1 month of randomization
- Peripheral neuropathy Grade \>/=2
- Uncontrolled cardiopulmonary dysfunction (e.g., high blood pressure, serious cardiac arrhythmia)
- Other current, severe, uncontrolled systemic disease (e.g., clinically significant metabolic disease, wound healing disorders, ulcers)
- Clinically significant bleeding within 30 days before enrollment
- For female participants, current pregnancy or lactation
- Major surgical procedure or significant traumatic injury within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment
- Infection with Human immunodeficiency virus (HIV) or hepatitis B virus, hepatitis C virus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (148)
Comprehensive Blood/Cancer Ctr
Bakersfield, California, 93309, United States
Stanford University School of Medicine
Stanford, California, 94305-5151, United States
Yale Cancer Center
New Haven, Connecticut, 06520, United States
University of Kansas; Medical Center & Medical pavilion
Westwood, Kansas, 66205, United States
Norton Healthcare Inc.
Louisville, Kentucky, 40202, United States
Massachusetts General Hospital.
Boston, Massachusetts, 02114, United States
Dana Farber Can Ins
Boston, Massachusetts, 02215, United States
Weill Cornell Medical College
New York, New York, 10065, United States
Vanderbilt
Nashville, Tennessee, 37232, United States
University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Fundación Investigar
Buenos Aires, 1025, Argentina
Hospital de Gastroenterologia Dr. Bonorino Udaondo ; Servicio de Oncología
Buenos Aires, C1264AAA, Argentina
Instituto de Oncología de Rosario
Rosario, S2000KZE, Argentina
UZ Leuven Gasthuisberg
Leuven, 3000, Belgium
Instituto Nacional de Cancer - INCa; Oncologia
Rio de Janeiro, Rio de Janeiro, 20560-120, Brazil
Clinica de Oncologia de Porto Alegre - CliniOnco
Porto Alegre, Rio Grande do Sul, 90430-090, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Hospital de Cancer de Barretos
Barretos, São Paulo, 14784-400, Brazil
Hospital Amaral Carvalho
Jaú, São Paulo, 17210-080, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, 01246-000, Brazil
Instituto de Oncologia de Sorocaba - CEPOS
Sorocaba, São Paulo, 18030-245, Brazil
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6, Canada
Brampton Memorial Hospital, William Osler Health Center
Brampton, Ontario, L6R 3J7, Canada
Toronto East General Hospital; Haematology/Oncology
Toronto, Ontario, M4C 3E7, Canada
St. Michael'S Hospital
Toronto, Ontario, M5B 1W8, Canada
The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
Beijing, 100071, China
Beijing Cancer Hospital
Beijing, 100142, China
Jilin Cancer Hospital
Changchun, 130012, China
the First Hospital of Jilin University
Changchun, 130021, China
Changzhou First People's Hospital
Changzhou, 213003, China
Third Affiliated Hospital of Third Military Medical University
Chongqing, 400042, China
Fujian Cancer Hospital
Fuzhou, 350014, China
Sun Yet-sen University Cancer Center
Guangzhou, 510060, China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, 310016, China
Harbin Medical University Cancer Hospital
Harbin, 150081, China
Jiangsu Cancer Hospital
Nanjing, 210009, China
The 81st Hospital of P.L.A.
Nanjing, China
Affiliated Hospital of Nantong University
Nantong, 226001, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Zhongshan Hospital Fudan University
Shanghai, 200032, China
Shanghai First People's Hospital
Shanghai, 200080, China
General Hospital of Shenyang Military Command of PLA
Shenyang, 110016, China
Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center
Wuhan, 430023, China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, 710061, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, 221004, China
Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
Hradec Králové, 500 05, Czechia
Fakultni nemocnice Olomouc; Onkologicka klinika
Olomouc, 779 00, Czechia
Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
Prague, 128 08, Czechia
Fakultní Nemocnice V Motole; Radioterapeuticko-Onkologicke Oddeleni
Prague, 150 06, Czechia
Tampere University Hospital; Dept of Oncology
Tampere, 33520, Finland
Hopital Augustin Morvan; Federation De Cancerologie
Brest, 29200, France
Hopital Beaujon; Gastro Enterologie 1
Clichy, 92118, France
Centre Val Aurelle Paul Lamarque; Medecine A1 A2
Montpellier, 34298, France
Hopital Saint Antoine; Hepatologie-Gastr-Enterologie
Paris, 75571, France
Hop Europeen Georges Pompidou; Gastro Enterologie
Paris, 75908, France
Hopital Robert Debre; Gastro Enterologie
Reims, 51092, France
Hopital Purpan; Unite Onco Digestive
Toulouse, 31059, France
Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo.
Berlin, 10117, Germany
Universitätsklinikum Köln
Cologne, 50937, Germany
Universitätsklinikum "Carl Gustav Carus"; Med. Klinik & Poliklinik I, Arbeitsgr. intern. Onkologie
Dresden, 01307, Germany
Facharztzentrum Eppendorf, Studien GbR
Hamburg, 20249, Germany
Tagesklinik Landshut; Hämatologie/Onkologie
Landshut, 84028, Germany
Onkologische Gemeinschaftspraxis
Magdeburg, 39104, Germany
Centro Oncológico Sixtino / Centro Oncológico SA
Guatemala City, 01010, Guatemala
Grupo Angeles
Guatemala City, 01015, Guatemala
Fovarosi Szent Laszlo Korhaz-Rendelointezet; Onkologiai Osztaly X
Budapest, 1097, Hungary
Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
Szeged, 6720, Hungary
Hetenyi Geza County Hospital; Onkologiai Kozpont
Szolnok, 5004, Hungary
Zala Megyei Kórház, Külsö Kórház, Pózva; Onkológiai Osztály
Zalaegerszeg, 8900, Hungary
Campus Universitario S.Venuta; Centro Oncologico T.Campanella
Catanzaro, Calabria, 88100, Italy
AZ.Osp S. Orsola - Malpighi-Reparto di Oncologia Medica
Bologna, Emilia-Romagna, 40138, Italy
A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica
Turin, Piedmont, 10126, Italy
Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1
Florence, Tuscany, 50139, Italy
A.O. Universitaria Pisana; Oncologia
Pisa, Tuscany, 56100, Italy
Aichi Cancer Center Hospital; Clinical Oncology
Aichi, 464-8681, Japan
Chiba Cancer Center; Gastroenterology
Chiba, 260-8717, Japan
National Cancer Center Hospital East; Gastroenterology
Chiba, 277-8577, Japan
National Hospital Organization Shikoku Cancer Center; Gastroenterology
Ehime, 791-0280, Japan
Hokkaido University Hospital：Gastroenterology
Hokkaido, 060-8648, Japan
Hyogo College Of Medicine; Upper Gastroenterology
Hyōgo, 663-8501, Japan
Hyogo Cancer Center; Gastroenterology
Hyōgo, 673-8558, Japan
Ibaraki Prefectural Central Hospital; Gastroenterology
Ibaraki, 309-1793, Japan
Tohoku Uni Hospital; Clinical Oncology
Miyagi, 980-8574, Japan
Osaka University Hospital; Surgery
Osaka, 565-0871, Japan
Kindai University Hospital; Medical Oncology
Osaka, 589-8511, Japan
Saitama Cancer Center; Gastroenterology
Saitama, 362-0806, Japan
Shizuoka Cancer Center; Gastroenterology
Shizuoka, 411-8777, Japan
Shizuoka General Hospital; Clinical Oncology
Shizuoka, 420-8527, Japan
Tochigi Cancer Center; Medical Oncology
Tochigi, 320-0834, Japan
National Cancer Center Hospital; Gastrointestinal Oncology
Tokyo, 104-0045, Japan
Toranomon Hospital; Medical Oncology
Tokyo, 105-8470, Japan
Tokyo Metropolitan Komagome Hospital; Chemotherapy
Tokyo, 113-8677, Japan
The Cancer Institute Hospital, JFCR; Gastroenterology
Tokyo, 135-8550, Japan
Hospital Wanita dan Kanak-Kanak Sabah
Sabah, Sabah, 88996, Malaysia
University Malaya Medical Centre; Clinical Oncology Unit,
Kuala Lumpur, 59100, Malaysia
Centenario Hospital Miguel Hidalgo
Aguascalientes, 20230, Mexico
Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre
Chihuahua City, 31000, Mexico
Hospital General de México; Unidad de Oncologia
Mexico City, 06726, Mexico
Centro Hemato Oncologico Paitilla
Panama City, 083200752, Panama
Hospital Nacional Almanzor Aguinaga Asenjo; Unidad De Investigacion Del Servicio De Oncologia Medica
Chiclayo, CIX, Peru
Hospital Nacional Adolfo Guevara Velasco
Cusco, 08006, Peru
Hospital Nacional Edgardo Rebagliati Martins
Jesus Maria, Lima 11, Peru
Instituto Nacional de Enfermedades Neoplasicas
Lima, 34, Peru
Perpetual Succour Hospital
Cebu, 6000, Philippines
Veterans Memorial Medical Ctr; Cancer Research Centre
Quezon City, Luzon, 1101, Philippines
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
Gdansk, 80-952, Poland
Szpital Uniwersytecki w Krakowie
Krakow, 31-501, Poland
Wielkopolskie Centrum Onkologii; im. Marii Skłodowskiej-Curie
Poznan, 61-866, Poland
Wojewódzki Szpital Specjalistyczny Nr 3
Rybnik, 44-200, Poland
Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie; Klinika Gastroenterologii Onkologicznej
Warsaw, 02-781, Poland
Institutul Clinic Fundeni Bucuresti
Bucharest, 022328, Romania
Spitalul Universitar CF Cluj-Napoca; Sectia Oncologie
Cluj-Napoca, 400015, Romania
Medisprof SRL
Cluj-Napoca, 400058, Romania
Spitalul Clinic Judetean Mures; Oncologie Medicala
Târgu Mureş, 540141, Romania
Arkhangelsk Regional Clinical Oncology Dispensary
Arkhangelsk, 163045, Russia
Ivanovo Regional Oncology Dispensary
Ivanovo, 153040, Russia
Omsk Region Clinical Oncology Dispensary; 1St Sergical Department
Omsk, 644013, Russia
State Budget Institution of Healthcare of Stavropol region Pyatigorsk Oncology Dispensary
Pyatigorsk, 357502, Russia
Tula Regional Oncology Dispensary
Tula, 300053, Russia
National Cancer Centre
Singapore, 169610, Singapore
Seoul National University Hospital
Seoul, 03080, South Korea
Asan Medical Center; Medical Oncology
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Yonsei University Severance Hospital; Medical Oncology
Seoul, 120-752, South Korea
Korea University Anam Hospital; Oncology Haemotology
Seoul, 136-705, South Korea
Seoul St.Mary's Hospital; Medical Oncology
Seoul, 137-807, South Korea
Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
Santander, Cantabria, 39008, Spain
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
Santiago de Compostela, La Coruña, 15706, Spain
Hospital Univ. Central de Asturias; Servicio de Oncologia
Oviedo, Principality of Asturias, 33011, Spain
Hospital Clinic i Provincial; Servicio de Farmacia
Barcelona, 08036, Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid, 28007, Spain
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, 28046, Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Seville, 41013, Spain
Hospital Universitario Miguel Servet; Servicio Oncologia
Zaragoza, 50009, Spain
Kaohsiung Chang Gung Memorial Hospital; Dept of Hem and Onc
Kaohsung, 883, Taiwan
National Taiwan Uni Hospital; Dept of Oncology
Taipei, 100, Taiwan
Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology
Taoyuan District, 333, Taiwan
Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department
Erzurum, 25240, Turkey (Türkiye)
Istanbul Bilim University School Of Medicine; Department Of Medical Oncology
Istanbul, 34300, Turkey (Türkiye)
Marmara Uni Faculty of Medicine; Medical Oncology
Istanbul, 34890, Turkey (Türkiye)
Ege Uni Medical Faculty; Oncology Dept
Izmir, 35100, Turkey (Türkiye)
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Sıhhiye, Ankara, 06100, Turkey (Türkiye)
Velindre Cancer Centre; Oncology Dept
Cardiff, CF14 2TL, United Kingdom
The Beatson West of Scotland Cancer Centre; Cancer Clinical Trials Unit
Glasgow, G12 0YN, United Kingdom
Royal Marsden Hospital; Dept of Med-Onc
London, SW3 6JJ, United Kingdom
Christie Hospital Nhs Trust; Medical Oncology
Manchester, M2O 4BX, United Kingdom
Royal Marsden Hospital; Dept of Medical Oncology
Sutton, SM2 5PT, United Kingdom
BRISTOL ONCOLOGY CENTRE; CLINICAL TRIALS UNIT; R & D department
Weston-super-Mare, BS23 4TQ, United Kingdom
Related Publications (2)
Shah MA, Kang YK, Thuss-Patience PC, Ohtsu A, Ajani JA, Van Cutsem E, Hoersch S, Harle-Yge ML, de Haas SL. Biomarker analysis of the GATSBY study of trastuzumab emtansine versus a taxane in previously treated HER2-positive advanced gastric/gastroesophageal junction cancer. Gastric Cancer. 2019 Jul;22(4):803-816. doi: 10.1007/s10120-018-00923-7. Epub 2019 Jan 31.
PMID: 30706247DERIVEDThuss-Patience PC, Shah MA, Ohtsu A, Van Cutsem E, Ajani JA, Castro H, Mansoor W, Chung HC, Bodoky G, Shitara K, Phillips GDL, van der Horst T, Harle-Yge ML, Althaus BL, Kang YK. Trastuzumab emtansine versus taxane use for previously treated HER2-positive locally advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma (GATSBY): an international randomised, open-label, adaptive, phase 2/3 study. Lancet Oncol. 2017 May;18(5):640-653. doi: 10.1016/S1470-2045(17)30111-0. Epub 2017 Mar 23.
PMID: 28343975DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated by the Sponsor as the primary analysis results did not meet the primary endpoint.
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2012
First Posted
July 17, 2012
Study Start
September 3, 2012
Primary Completion
June 30, 2015
Study Completion
April 30, 2016
Last Updated
May 12, 2017
Results First Posted
August 11, 2016
Record last verified: 2017-05