A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies

Sponsor
Genentech, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT00781612
Collaborator
Hoffmann-La Roche (Industry)
720
221
1
251.1
3.3
0

Study Details

Study Description

Brief Summary

This is a global, multicenter, open-label safety extension study. Participants receiving single-agent trastuzumab emtansine or trastuzumab emtansine administered in combination with other anti-cancer therapies in a Genentech / Roche-sponsored parent study who are active and receiving benefit at the closure of parent study are eligible for continued treatment in this study.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
720 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label, Multicenter Extension Study of Trastuzumab Emtansine Administered as a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd-Sponsored Trastuzumab Emtansine Study
Actual Study Start Date :
Oct 16, 2008
Anticipated Primary Completion Date :
Sep 20, 2029
Anticipated Study Completion Date :
Sep 20, 2029

Arms and Interventions

Arm Intervention/Treatment
Experimental: Trastuzumab Emtansine

Participants will receive trastuzumab emtansine either as a single agent or in combination with other anti-cancer therapy (atezolizumab, paclitaxel, trastuzumab and docetaxel). Participants will receive the same dose and schedule on Cycle 1, Day 1 at which it was given at the end of the parent study. Study drug will be administered in 21-day cycles or weekly, depending on the schedule used in the parent study. Participants will receive study treatment until disease progression or unacceptable toxicity.

Drug: Docetaxel
Docetaxel will be administered as per local prescribing information.

Drug: Paclitaxel
Paclitaxel will be administered as per local prescribing information.

Drug: Pertuzumab
Pertuzumab will be administered intravenously at a dose of 420 milligrams (mg) no more frequently than every 3 weeks (Q3W) (or as directed in the parent study protocol if less than Q3W).
Other Names:
  • Perjeta
  • Drug: Trastuzumab
    Trastuzumab will be administered as per local prescribing information.
    Other Names:
  • Herceptin
  • Drug: Trastuzumab Emtansine
    Trastuzumab emtansine will be administered as intravenous (IV) infusion. Participants on weekly dosing schedule of trastuzumab emtansine in parent study, may switch to Q3W schedule as per the clinical judgment of the investigator. The starting dose of Q3W schedule must not exceed 3.6 milligrams per kilograms (mg/kg).
    Other Names:
  • Kadcyla; T-DM1
  • Drug: Atezolizumab
    Atezolizumab will be administered at a dose of 1200 mg by IV infusion every three weeks (Q3W)
    Other Names:
  • Tecentriq
  • Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline up to 30 days after last dose of study drug administration (up to approximately 14 years)]

    2. Percentage of Participants With Adverse Events Leading to Study Treatment Discontinuation or Dose Reduction [Baseline up to 30 days after last dose of study drug administration (up to approximately 14 years)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Completed single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment in the parent study or who continue to receive single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment at the time of the parent study closure and received the last study drug dose within the 6 weeks (42 days) prior to the first dose of study therapy on the extension study or Continue to receive treatment in the control arm of study BO21976/TDM4450g (NCT00679341) at the time of the parent study closure if the participant received the last dose of control arm study drug within the 6 weeks (42 days) prior to the first dose of control arm study therapy in the extension study

    • Participants in the control arm from Study BO21976/TDM4450g whose disease progression has occurred during the transition interval between the parent study and this extension study may initiate trastuzumab emtansine treatment at the time of enrollment into study TDM4529g (NCT00781612)

    • Expectation by the investigator that the participant may continue to benefit from additional single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment or Expectation of the investigator that the participant may continue to benefit from control arm treatment as given in study BO21976/TDM4450g and at the time of disease progression may benefit from single-agent trastuzumab emtansine treatment

    • Women of childbearing potential and men with partners of childbearing potential, must be willing to use a highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception by the participants and/or partner, and to continue the use of contraception for the duration of study treatment and for at least 5 months after the final dose of atezolizumab (if applicable) or 7 months after the final dose of trastuzumab emtansine or pertuzumab, whichever is later. Women must refrain from donating eggs during this same period

    • Male participants whose partners are pregnant should use condoms for the duration of the pregnancy. Men must refrain from donating sperm during this same period

    Exclusion Criteria:
    • AEs leading to single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment discontinuation in the parent study

    • Ongoing SAEs from the parent study

    • Progressive disease on single-agent trastuzumab emtansine or a trastuzumab emtansine-containing regimen during the parent study or before starting the extension study, with the exception of participants from study TDM4688g (NCT00943670) with early disease progression who went on to receive pertuzumab + trastuzumab emtansine treatment and have not experienced further disease progression on the combination regimen

    • Peripheral neuropathy of Grade greater than or equal to (>/=) 3 per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0, 4.0 or 5.0, as utilized in the parent study

    • History of symptomatic congestive heart failure ([CHF]; New York Heart Association [NYHA] Classes II-IV), ventricular arrhythmia requiring treatment, current unstable angina, or history of myocardial infarction within 6 months prior to study entry

    • Severe dyspnea at rest due to complications of advanced malignancy or current requirement for continuous oxygen therapy

    • Current severe, uncontrolled systemic disease (for example [e.g.] clinically significant cardiovascular, pulmonary, or metabolic disease)

    • Major surgical procedure or significant traumatic injury within 28 days prior to study entry or anticipation of the need for major surgery during the course of study treatment

    • Current pregnancy or lactation

    • History of receiving any investigational treatment or other systemic therapy directed at controlling cancer (e.g., chemotherapy, trastuzumab, etc.) since the participant's last study drug dose in the parent study

    • History of hypersensitivity with previous trastuzumab emtansine or any agent used with trastuzumab emtansine in the parent study, precluding further dosing

    • Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope National Medical Center Duarte California United States 91010
    2 Can Care Assoc Med Group Inc; Beach Cities Offices Los Angeles California United States 90095-1772
    3 Comp Cancer Centers of Nevada Los Angeles California United States 90095-1772
    4 Univ of Calif, San Francisco; Breast Cancer Center San Francisco California United States 94115
    5 Central Coast Medical Oncology Santa Maria California United States 93454
    6 UCLA Oncology Office; Oncology Santa Monica California United States 90404
    7 Stanford Cancer Institute Stanford California United States 94305
    8 Kaiser Permanente; Oncology Clinical Trials Vallejo California United States 94589
    9 Kaiser Permanente - Walnut Creek Walnut Creek California United States 94596
    10 Univ of Colorado Canc Ctr Aurora Colorado United States 80045
    11 University of Colorado Aurora Colorado United States 80045
    12 Rocky Mountain Cancer Center - Denver Littleton Colorado United States 80120
    13 Christina Care Institutional Review Board Newark Delaware United States 18713
    14 Florida Cancer Specialists; Department of Oncology Fort Myers Florida United States 33901-8101
    15 Baptist - MD Anderson Cancer Center Jacksonville Florida United States 32207
    16 Univ of Miami Health Systems Miami Florida United States 33136
    17 Memorial Cancer Institute at Memorial West Pembroke Pines Florida United States 33028
    18 Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building) Saint Petersburg Florida United States 33705
    19 Florida Cancer Specialists - Tampa (Dr. MLK Blvd) Tampa Florida United States 33607
    20 Northwest Georgia Oncology Centers PC - Marietta Marietta Georgia United States 30060
    21 Kootenai Cancer Center Post Falls Idaho United States 83854
    22 Loyola University Med Center Maywood Illinois United States 60153
    23 Illinois Cancer Care Peoria Illinois United States 61615
    24 Midwestern Regional Medical Center; Office of Research Zion Illinois United States 60099
    25 Indiana University Melvin and Bren Simon Cancer Center Indianapolis Indiana United States 46202
    26 Hematology-Oncology; Associates of the Quad Cities Bettendorf Iowa United States 52722
    27 Oncology Assoc of Cedar Rapids; Iowa Cancer Care Cedar Rapids Iowa United States 52403
    28 Cancer Center of Kansas Wichita Kansas United States 67214-3728
    29 New England Cancer Specialists Scarborough Maine United States 04074
    30 Anne Arundel Medical Center; Anne Arundel Health System Annapolis Maryland United States 21401
    31 Johns Hopkins Univ Med Center Baltimore Maryland United States 21231
    32 Massachusetts General Hospital Boston Massachusetts United States 02114
    33 Dana Farber Cancer Institute; Breast Oncology Boston Massachusetts United States 02115
    34 Karmanos Cancer Institute Detroit Michigan United States 48201
    35 Minnesota Oncology Hematology, Pa Minneapolis Minnesota United States 55407
    36 University of Minnesota. Minneapolis Minnesota United States 55454
    37 Mayo Clinic - Rochester Rochester Minnesota United States 55905
    38 Capitol Comprehensive CA Care Jefferson City Missouri United States 65101
    39 St. John's Mercy Medical Ctr; David C. Pratt Cancer Center Saint Louis Missouri United States 63141
    40 Mercy Clinic Cancer & Hematology Springfield Missouri United States 65804
    41 St. Barnabas Health Care Sys Livingston New Jersey United States 07039
    42 NS-Long Island Jewish Hlth Sys Lake Success New York United States 11042
    43 Laura and ISAAC Perlmutter Cancer Center at NYU Langone. New York New York United States 10016
    44 Memorial Sloan-Kettering Cancer Center New York New York United States 10065
    45 Clinical Research Alliance Westbury New York United States 11590
    46 Carolina Oncology Specialists, PA - Hickory Hickory North Carolina United States 28602
    47 The Cleveland Clinic Foundation Cleveland Ohio United States 44195
    48 The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc. Columbus Ohio United States 43219
    49 Northwest Cancer Specialists - Portland (N Broadway) Portland Oregon United States 97227
    50 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    51 SCRI Tennessee Oncology Chattanooga Chattanooga Tennessee United States 37404
    52 Sarah Cannon Cancer Center Germantown Tennessee United States 38138
    53 Vanderbilt Ingram Cancer Ctr Nashville Tennessee United States 37232
    54 Texas Oncology Bedford Texas United States 76022
    55 Texas Oncology - Dallas Presbyterian Hospital Dallas Texas United States 75231
    56 Millennium Research & Clinical Development Houston Texas United States 77090
    57 US Oncology Research Pharm. Irving Texas United States 75063
    58 US Oncology Irving Texas United States 75063
    59 USO Plano Texas United States 75075-7787
    60 Cancer Therapy & Research Center San Antonio Texas United States 78229
    61 US Oncology Research, Inc. The Woodlands Texas United States 77380
    62 USO - Tyler Cancer Ctr Tyler Texas United States 75702
    63 Univ of WA Medical Center Seattle Washington United States 98109
    64 Uni of Washington Medical Center; Dept of Oncology Seattle Washington United States 98195
    65 Northwest Medical Specialties Tacoma Washington United States 98405
    66 Peninsula and South Eastern Haematology and Oncology Group Frankston Victoria Australia 3199
    67 Peter MacCallum Cancer Center North Melbourne Victoria Australia 3051
    68 Klinik Favoriten; 1 Medizinische Abteilung Wien Austria 1100
    69 UZ Gent Gent Belgium 9000
    70 Sint Augustinus Wilrijk, Apotheek Wilrijk Belgium 2610
    71 Nucleo de Oncologia da Bahia - NOB Salvador, Bahia BA Brazil 40170-380
    72 Trymed Clinical Research Belo Horizonte MG Brazil 30150-281
    73 Instituto Nacional de Cancer - INCa; Oncologia Rio de Janeiro RJ Brazil 20560-120
    74 Santa Casa de Misericordia de Porto Alegre Porto Alegre RS Brazil 90050-170
    75 Clinica de Oncologia de Porto Alegre - CliniOnco Porto Alegre RS Brazil 90430-090
    76 Hospital Sao Lucas - PUCRS Porto Alegre RS Brazil 90610-000
    77 Hospital Nossa Senhora da Conceicao Porto Alegre RS Brazil 91350-200
    78 Clinica de Neoplasias Litoral Itajai SC Brazil 88301-220
    79 Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia Santo Andre SP Brazil 09060-650
    80 Hospital Perola Byington Sao Paulo SP Brazil 01317-000
    81 Complex Oncology Center - Plovdiv First Internal Chemotherapy Department Plovdiv Bulgaria 4004
    82 SHATO - Sofia Sofia Bulgaria 1756
    83 BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre) Kelowna British Columbia Canada V1Y 5L3
    84 Ottawa Regional Cancer Centre; Civic Hospital Division Ottawa Ontario Canada K1H 8L6
    85 St. Michael'S Hospital Toronto Ontario Canada M5B 1W8
    86 University Health Network; Princess Margaret Hospital; Medical Oncology Dept Toronto Ontario Canada M5G 2M9
    87 Centre Hospitalier de l'Université de Montréal (CHUM) Montreal Quebec Canada H2X 0C2
    88 Saskatoon Cancer Centre Saskatoon Saskatchewan Canada SK S7N 4H4
    89 CHU de Québec - Hôpital du Saint-Sacrement / ONCOLOGY Quebec Canada G1S 4L8
    90 Fundacion Arturo Lopez Perez Santiago Chile 7500921
    91 Beijing Cancer Hospital Beijing China 100142
    92 Sun Yet-sen University Cancer Center Guangzhou China 510060
    93 Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department Hangzhou City China 310022
    94 Harbin Medical University Cancer Hospital Harbin China 150081
    95 Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University) Nanjing City China 210029
    96 Jiangsu Cancer Hospital Nanjing City China 211100
    97 Fudan University Shanghai Cancer Center Shanghai City China 200120
    98 Clinical Hospital Centre Zagreb Zagreb Croatia 10000
    99 Masarykuv onkologicky ustav Brno Czechia 656 53
    100 Fakultni nemocnice Olomouc; Onkologicka klinika Olomouc Czechia 779 00
    101 Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika Praha 2 Czechia 128 08
    102 Odense Universitetshospital, Onkologisk Afdeling R Odense C Denmark 5000
    103 Vejle Sygehus; Onkologisk Afdeling Vejle Denmark 7100
    104 Centre Francois Baclesse; Comite Sein Caen France 14076
    105 Centre Georges Francois Leclerc; Oncologie 3 Dijon France 21079
    106 Centre Hospitalier Departemental Les Oudairies La Roche Sur Yon France 85925
    107 Institut Paoli Calmettes; Oncologie Medicale Marseille France 13273
    108 Institut régional du Cancer Montpellier Montpellier France 34298
    109 Hopital Tenon Paris France 75020
    110 Institut Curie; Oncologie Medicale Paris France 75231
    111 Ico Rene Gauducheau; Oncologie Saint Herblain France 44805
    112 Studienzentrum Aschaffenburg Aschaffenburg Germany 63739
    113 HELIOS Klinikum Berlin-Buch; Klinik für Gynäkologie und Geburtshilfe Berlin Germany 13125
    114 Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche Berlin Germany 14169
    115 Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum Essen Germany 45136
    116 Uniklinik Köln, Klinik und Poliklinik und Geburtshilfe; Brustzentrum Köln Köln Germany 50931
    117 Rotkreuzklinikum München; Frauenklinik Muenchen Germany 80637
    118 Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde Muenchen Germany 81377
    119 Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher Stralsund Germany 18439
    120 Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker Würzburg Germany 97080
    121 Grupo Angeles Guatemala City Guatemala 01015
    122 Queen Mary Hospital; Dept of Medicine Hong Kong Hong Kong
    123 Szent Margit Hospital; Dept. of Oncology Budapest Hungary 1032
    124 Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika Budapest Hungary 1125
    125 Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika Debrecen Hungary 4032
    126 Markusovszky Hospital Szombathely Hungary 9700
    127 Shaare Zedek Medical Center Jerusalem Israel 9103102
    128 Kaplan Medical Center; Oncology Inst. Rehovot Israel 7610001
    129 Tel Aviv Sourasky Medical Ctr; Oncology Tel Aviv Israel 6423906
    130 Ospedale San Carlo; Day Hospital Oncologia Medica Potenza Basilicata Italy 85100
    131 Campus Universitario S.Venuta; Centro Oncologico T.Campanella Catanzaro Calabria Italy 88100
    132 Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica Napoli Campania Italy 80131
    133 IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica Meldola Emilia-Romagna Italy 47014
    134 IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica Meldola Emilia-Romagna Italy 47014
    135 Ospedale Regionale Di Parma; Divisione Di Oncologia Medica Parma Emilia-Romagna Italy 43100
    136 RCCS - Centro di Riferimento; Oncologia Medica B Aviano (PN) Friuli-Venezia Giulia Italy 33081
    137 Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia Udine Friuli-Venezia Giulia Italy 33100
    138 Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1 Milano Lombardia Italy 20133
    139 Istituto Europeo Di Oncologia Milano Lombardia Italy 20141
    140 Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico Candiolo Piemonte Italy 10060
    141 Ospedale Civile; Oncologia Medica Sassari Sardegna Italy 07100
    142 Humanitas Istituto Clinico Catanese S.p.A Misterbianco (CT) Sicilia Italy 95045
    143 A.O. Universitaria Pisana; Oncologia Pisa Toscana Italy 56100
    144 Ospedale Misericordia E Dolce; Oncologia Medica Prato Toscana Italy 59100
    145 Hiroshima University Hospital; Breast Surgery Hiroshima Japan 734-8551
    146 Hyogo Cancer Center; Breast Surgery Hyogo Japan 673-8558
    147 Saitama Medical University International Medical Center; Breast Oncology Saitama Japan 350-1298
    148 Kyungpook National University Medical Center; Oncology Daegu Korea, Republic of 702-210
    149 National Cancer Center Goyang-si Korea, Republic of 10408
    150 Gachon University Gil Medical Center Incheon Korea, Republic of 21565
    151 Seoul National University Hospital Seoul Korea, Republic of 03080
    152 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of 03722
    153 Asan Medical Center Seoul Korea, Republic of 05505
    154 Asan Medical Center Seoul Korea, Republic of 05505
    155 Samsung Medical Center Seoul Korea, Republic of 06351
    156 Consultorio de Medicina Especializada Mexico Mexico CITY (federal District) Mexico 03100
    157 Centro de Investigacion; Clinica Del Pacifico Acapulco Mexico 39670
    158 Instituto Nacional de Cancer D.f. Mexico 14080
    159 Oaxaca Site Management Organization Oaxaca Mexico 68000
    160 Auckland city hospital; Auckland Regional Cancer Centre and Blood Service Auckland New Zealand 1023
    161 Private Health Organization Acibadem Sistina Hospital Skopje North Macedonia 1000
    162 Oslo Universitetssykehus HF; Radiumhospitalet Oslo Norway 0310
    163 Centro Hemato Oncologico Panama Panama Panama 0832
    164 Instituto;Oncologico Miraflores Lima Peru 18
    165 Instituto Nacional de Enfermedades Neoplasicas Lima Peru Lima 34
    166 Cebu Cancer Institute; Perpetual Succour Hospital Cebu City Philippines 6000
    167 Veterans Memorial Medical Ctr; Cancer Research Centre Quezon City Philippines 1101
    168 Cardinal Santos Medical Center San Juan Philippines 1502
    169 Uniwersyteckie Centrum Kliniczne Gdansk Poland
    170 Świętokrzyskie Centrum Onkologii; Dział Chemioterapii Kielce Poland 25-734
    171 COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej Lublin Poland 20-090
    172 Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii Otwock Poland 05-400
    173 Wielkopolskie Centrum Onkologii; Oddzial Chemioterapii Poznan Poland 61-866
    174 Wojewódzki Szpital Specjalistyczny Nr 3 Rybnik Poland 44-200
    175 Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Nowotworow Piersi i Chirurgii Rekonstr Warszawa Poland 02-781
    176 Hospital da Luz; Departamento de Oncologia Medica Lisboa Portugal 1500-650
    177 IPO do Porto; Servico de Oncologia Medica Porto Portugal 4200-072
    178 FSBI"National Medical Research Center of Oncology named after N.N.Petrov" MHRF St Petersburg Leningrad Russian Federation 197758
    179 Blokhin Cancer Research Center; Combined Treatment Moskva Moskovskaja Oblast Russian Federation 115478
    180 City Clinical Oncology Hospital Moscow Russian Federation 143423
    181 City Oncology Dispensary St Petersburg Russian Federation
    182 SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary Stavropol Russian Federation 355045
    183 Bashkirian Republican Clinical Oncology Dispensary UFA Russian Federation 450054
    184 National University Hospital; National University Cancer Institute, Singapore (NCIS) Singapore Singapore 119228
    185 Institute of Oncology Ljubljana Ljubljana Slovenia 1000
    186 Hospital General Universitario de Elche; Servicio de Oncologia Elche Alicante Spain 03203
    187 Hospital de Jerez de la Frontera; Servicio de Oncologia Jerez de La Frontera Cadiz Spain 11407
    188 Hospital de Donostia; Servicio de Oncologia Medica San Sebastian Guipuzcoa Spain 20080
    189 Hospital Severo Ochoa; Servicio de Oncologia Leganes Madrid Spain 28911
    190 Hospital del Mar; Servicio de Oncologia Barcelona Spain 08003
    191 Hospital Univ Vall d'Hebron; Servicio de Oncologia Barcelona Spain 08035
    192 Hospital Duran i Reynals; Oncologia Barcelona Spain 08907
    193 Hospital San Pedro De Alcantara; Servicio de Oncologia Caceres Spain 10003
    194 Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia Lerida Spain 25198
    195 Hospital General Universitario Gregorio Marañon; Servicio de Oncologia Madrid Spain 28007
    196 Hospital Ramon y Cajal; Servicio de Oncologia Madrid Spain 28034
    197 Hospital Universitario La Paz; Servicio de Oncologia Madrid Spain 28046
    198 Hospital Universitario Virgen del Rocio; Servicio de Oncologia Sevilla Spain 41013
    199 Hospital Universitario Miguel Servet; Servicio Oncologia Zaragoza Spain 50009
    200 Mälarsjukhuset; Onkologkliniken Sörmland Eskilstuna Sweden 63188
    201 Universitätsspital Zürich Zürich Switzerland 8091
    202 National Cheng Kung Uni Hospital; Surgery Tainan Taiwan 704
    203 Chi-Mei Medical Center Tainan Taiwan 736
    204 Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology Taipei City Taiwan 11259
    205 National Taiwan Uni Hospital; Dept of Oncology Taipei Taiwan 100
    206 Chang Gung Memorial Hospital - Linkou Taoyuan Taiwan 333
    207 Bumrungrad International Hosp Bangkok Thailand 10110
    208 Rajavithi Hospital; Division of Medical Oncology Bangkok Thailand 10400
    209 Ninewells Hospital Dundee United Kingdom DD12 9SY
    210 Western General Hospital; Clinical Oncology Edinburgh United Kingdom EH4 2XU
    211 Diana Princess of Wales Hosp. Grimsby United Kingdom DN33 2BA
    212 Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust Lancaster United Kingdom LA1 4RP
    213 Royal Free Hospital; Dept of Oncology London United Kingdom NW3 2QG
    214 Christie Hospital NHS Trust Manchester United Kingdom M20 4BX
    215 Mount Vernon Hospital Middlesex United Kingdom HA6 2RN
    216 Mount Vernon Cancer Centre Northwood United Kingdom HA6 2RN
    217 Nottingham City Hospital; Oncology Nottingham United Kingdom NG5 1PB
    218 Poole General Hospital Poole United Kingdom BH15 2JB
    219 Queen's Hospital; Oncology Romford United Kingdom RM7 0AG
    220 Abertawe and Bro Morgannwg NHS Trust; Clinical Researdh Institute Swansea United Kingdom SA6 6NL
    221 Royal Cornwall Hospital Truro United Kingdom TR1 3LQ

    Sponsors and Collaborators

    • Genentech, Inc.
    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Genentech, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Genentech, Inc.
    ClinicalTrials.gov Identifier:
    NCT00781612
    Other Study ID Numbers:
    • TDM4529g
    • BO25430
    • 2010-021067-32
    First Posted:
    Oct 29, 2008
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Aug 1, 2022

    Study Results

    No Results Posted as of Aug 18, 2022