Clinical trial NCT00781612: 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
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Neoplasm Metastasis
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Hoffmann-La Roche
First posted: 2008-10-29
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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, 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

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 30 days after last dose of study drug administration (up to approximately 14 years)
measure: Percentage of Participants With Adverse Events Leading to Study Treatment Discontinuation or Dose Reduction
timeFrame: Baseline up to 30 days after last dose of study drug administration (up to approximately 14 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Redondo Beach
country: United States
facility: Can Care Assoc Med Group Inc
state: California
city: San Francisco
country: United States
facility: Univ of Calif, San Francisco
state: California
city: San Luis Obispo
country: United States
facility: Central Coast Medical Oncology
state: California
city: Santa Monica
country: United States
facility: UCLA Oncology Office
state: California
city: Stanford
country: United States
facility: Stanford Cancer Institute
state: California
city: Walnut Creek
country: United States
facility: Kaiser Permanente - Walnut Creek
state: California
city: Aurora
country: United States
facility: Univ of Colorado Canc Ctr
state: Colorado
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Cancer Center - Denver
state: Colorado
city: Newark
country: United States
facility: Christina Care Institutional Review Board
state: Delaware
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Pembroke Pines
country: United States
facility: Memorial Cancer Institute at Memorial West
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists (St. Petersburg ? St. Anthony?s Professional Building)
state: Florida
city: Tampa
country: United States
facility: Florida Cancer Specialists - Tampa (Dr. MLK Blvd)
state: Florida
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers PC - Marietta
state: Georgia
city: Post Falls
country: United States
facility: Kootenai Cancer Center
state: Idaho
city: Maywood
country: United States
facility: Loyola University Med Center
state: Illinois
city: Peoria
country: United States
facility: Illinois Cancer Care
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Cancer Center
state: Indiana
city: Bettendorf
country: United States
facility: Hematology-Oncology
state: Iowa
city: Cedar Rapids
country: United States
facility: Oncology Assoc of Cedar Rapids
state: Iowa
city: Annapolis
country: United States
facility: Anne Arundel Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Univ Med Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology, Pa
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota.
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: Saint Louis
country: United States
facility: St. John's Mercy Medical Ctr
state: Missouri
city: Springfield
country: United States
facility: Mercy Clinic Cancer & Hematology
state: Missouri
city: Las Vegas
country: United States
facility: Comp Cancer Centers of Nevada
state: Nevada
city: Livingston
country: United States
facility: St. Barnabas Health Care Sys
state: New Jersey
city: Lake Success
country: United States
facility: Clinical Research Alliance
state: New York
city: Lake Success
country: United States
facility: NS-Long Island Jewish Hlth Sys
state: New York
city: New York
country: United States
facility: Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Hickory
country: United States
facility: Carolina Oncology Specialists, PA - Hickory
state: North Carolina
city: Columbus
country: United States
facility: The Mark H. Zangmeister Ctr
state: Ohio
city: Portland
country: United States
facility: Northwest Cancer Specialists - Portland (N Broadway)
state: Oregon
city: Chattanooga
country: United States
facility: Sarah Cannon Research Institute / Tennessee Oncology
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute / Tennessee Oncology
state: Tennessee
city: Bedford
country: United States
facility: Texas Oncology
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Dallas Presbyterian Hospital
state: Texas
city: Plano
country: United States
facility: USO
state: Texas
city: San Antonio
country: United States
facility: Cancer Therapy & Research Center
state: Texas
city: Tyler
country: United States
facility: USO - Tyler Cancer Ctr
state: Texas
city: Seattle
country: United States
facility: Uni of Washington Medical Center
state: Washington
city: Seattle
country: United States
facility: Univ of WA Medical Center
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties
state: Washington
city: Frankston
country: Australia
facility: Peninsula and South Eastern Haematology and Oncology Group
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Center
state: Victoria
city: Gent
country: Belgium
facility: UZ Gent
city: Wilrijk
country: Belgium
facility: Sint Augustinus Wilrijk, Apotheek
city: Porto Alegre
country: Brazil
facility: Clinica de Oncologia de Porto Alegre - CliniOnco
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao
state: Rio Grande Do Sul
city: Itajai
country: Brazil
facility: Clinica de Neoplasias Litoral
state: Santa Catarina
city: Santo Andre
country: Brazil
facility: Faculdade de Medicina do ABC - FMABC
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Hospital Perola Byington
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Cancer - INCa
city: Plovdiv
country: Bulgaria
facility: Complex Oncology Center - Plovdiv First Internal Chemotherapy Department
city: Sofia
country: Bulgaria
facility: SHATO - Sofia
city: Kelowna
country: Canada
facility: BC Cancer ? Kelowna (Sindi Ahluwalia Hawkins Centre)
state: British Columbia
city: Ottawa
country: Canada
facility: Ottawa Regional Cancer Centre
state: Ontario
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre
state: Saskatchewan
city: Quebec
country: Canada
facility: CHU de Québec ? Hôpital du Saint-Sacrement / ONCOLOGY
city: Santiago
country: Chile
facility: Fundacion Arturo Lopez Perez
city: Beijing
country: China
facility: The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Changchun
country: China
facility: the First Hospital of Jilin University
city: Guangzhou City
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
city: Guangzhou
country: China
facility: Sun Yet-sen University Cancer Center
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Nanjing City
country: China
facility: Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
city: Nanjing City
country: China
facility: Jiangsu Cancer Hospital
city: Shanghai City
country: China
facility: Fudan University Shanghai Cancer Center
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Praha 2
country: Czechia
facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice
city: Odense
country: Denmark
facility: Odense Universitetshospital, Onkologisk Afdeling R
city: Vejle
country: Denmark
facility: Vejle Sygehus
city: Caen
country: France
facility: Centre Francois Baclesse
city: Dijon
country: France
facility: Centre Georges Francois Leclerc
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Montpellier
country: France
facility: Institut régional du Cancer Montpellier
city: Paris
country: France
facility: Hopital Tenon
city: Paris
country: France
facility: Institut Curie
city: Saint Herblain
country: France
facility: Ico Rene Gauducheau
city: Saint-Cloud
country: France
facility: Institut Curie - Hopital Rene Huguenin
city: Aschaffenburg
country: Germany
facility: Studienzentrum Aschaffenburg
city: Berlin
country: Germany
facility: Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche
city: Berlin
country: Germany
facility: HELIOS Klinikum Berlin-Buch
city: Muenchen
country: Germany
facility: Rotkreuzklinikum München
city: Muenchen
country: Germany
facility: Klinikum der Universität München
city: Guatemala City
country: Guatemala
facility: Grupo Angeles
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Budapest
country: Hungary
facility: Szent Margit Hospital
city: Debrecen
country: Hungary
facility: Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika
city: Szombathely
country: Hungary
facility: Markusovszky Hospital
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Ctr
city: Potenza
country: Italy
facility: Ospedale San Carlo
state: Basilicata
city: Catanzaro
country: Italy
facility: Campus Universitario S.Venuta
state: Calabria
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Irccs Fondazione g. PASCALE
state: Campania
city: Meldola
country: Italy
facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
state: Emilia-Romagna
city: Parma
country: Italy
facility: Ospedale Regionale Di Parma
state: Emilia-Romagna
city: Aviano (PN)
country: Italy
facility: RCCS - Centro di Riferimento
state: Friuli-Venezia Giulia
city: Udine
country: Italy
facility: Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia
state: Friuli-Venezia Giulia
city: Milano
country: Italy
facility: Irccs Istituto Nazionale Dei Tumori (Int)
state: Lombardia
city: Milano
country: Italy
facility: Istituto Europeo Di Oncologia
state: Lombardia
city: Candiolo
country: Italy
facility: Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo
state: Piemonte
city: Sassari
country: Italy
facility: Ospedale Civile
state: Sardegna
city: Misterbianco (CT)
country: Italy
facility: Humanitas Istituto Clinico Catanese S.p.A
state: Sicilia
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Hyogo
country: Japan
facility: Hyogo Cancer Center
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Medical Center
city: Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Acapulco
country: Mexico
facility: Centro de Investigacion
state: Guerrero
city: D.f.
country: Mexico
facility: Instituto Nacional de Cancer
state: Mexico CITY (federal District)
city: Distrito Federal
country: Mexico
facility: Consultorio de Medicina Especializada
city: Auckland
country: New Zealand
facility: Auckland city hospital
city: Skopje
country: North Macedonia
facility: Private Health Organization Acibadem Sistina Hospital
city: Oslo
country: Norway
facility: Oslo Universitetssykehus HF
city: Panama City
country: Panama
facility: The Panama Clinic
city: Lima
country: Peru
facility: Instituto Nacional de Enfermedades Neoplasicas
city: Lima
country: Peru
facility: Instituto
city: Cebu City
country: Philippines
facility: Cebu Cancer Institute
city: Quezon City
country: Philippines
facility: Veterans Memorial Medical Ctr
city: San Juan
country: Philippines
facility: Cardinal Santos Medical Center
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Kielce
country: Poland
facility: ?wi?tokrzyskie Centrum Onkologii
city: Otwock
country: Poland
facility: Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Onkologii
city: Rybnik
country: Poland
facility: Wojewódzki Szpital Specjalistyczny Nr 3
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie
city: Lisboa
country: Portugal
facility: Hospital da Luz
city: UFA
country: Russian Federation
facility: Bashkirian Republican Clinical Oncology Dispensary
state: Baskortostan
city: Ufa
country: Russian Federation
facility: SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan
state: Baskortostan
city: Moscow
country: Russian Federation
facility: City Clinical Oncology Hospital
state: Moskovskaja Oblast
city: Moskva
country: Russian Federation
facility: Blokhin Cancer Research Center
state: Moskovskaja Oblast
city: ST Petersburg
country: Russian Federation
facility: FSBI?National Medical Research Center of Oncology named after N.N.Petrov? MHRF
state: Sankt Petersburg
city: St Petersburg
country: Russian Federation
facility: City Oncology Dispensary
state: Sankt Petersburg
city: Stavropol
country: Russian Federation
facility: SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary
city: Ljubljana
country: Slovenia
facility: Institute of Oncology Ljubljana
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
city: Jerez de La Frontera
country: Spain
facility: Hospital de Jerez de la Frontera
state: Cadiz
city: San Sebastian
country: Spain
facility: Hospital de Donostia
state: Guipuzcoa
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Vall d'Hebron Institute of Oncology (VHIO), Barcelona
city: Barcelona
country: Spain
facility: Hospital Duran i Reynals
city: Caceres
country: Spain
facility: Hospital San Pedro De Alcantara
city: Lerida
country: Spain
facility: Hospital Universitari Arnau de Vilanova de Lleida
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
city: Tainan
country: Taiwan
facility: Chi-Mei Medical Center
city: Taipei
country: Taiwan
facility: National Taiwan Uni Hospital
city: Bangkok
country: Thailand
facility: Bumrungrad International Hosp
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: Grimsby
country: United Kingdom
facility: Diana Princess of Wales Hosp.
city: Lancaster
country: United Kingdom
facility: Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust
city: London
country: United Kingdom
facility: Royal Free Hospital
city: Manchester
country: United Kingdom
facility: Christie Hospital NHS Trust
city: Middlesex
country: United Kingdom
facility: Mount Vernon Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
city: Poole
country: United Kingdom
facility: Poole General Hospital
city: Romford
country: United Kingdom
facility: Queen's Hospital
city: Swansea
country: United Kingdom
facility: Abertawe and Bro Morgannwg NHS Trust
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: