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Active (not recruiting) Phase 2 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

Phase 2 – studying effectiveness and dosage
Conditions: Neoplasm Metastasis

Sponsor: Genentech, Inc.

trial.available_in: БГ
Overview
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.
Who can participate
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
Locations 32
Australia (1)
Peninsula and South Eastern Haematology and Oncology Group
Frankston , Victoria
Belgium (1)
UZ Gent
Ghent
Brazil (1)
Clinica de Oncologia de Porto Alegre - CliniOnco
Porto Alegre , Rio Grande do Sul
Bulgaria (1)
Complex Oncology Center - Plovdiv First Internal Chemotherapy Department
Plovdiv
Canada (1)
BC Cancer ? Kelowna (Sindi Ahluwalia Hawkins Centre)
Kelowna , British Columbia
Chile (1)
Fundacion Arturo Lopez Perez
Santiago
China (1)
The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
Beijing
Czech Republic (1)
Fakultni nemocnice Olomouc
Olomouc
Denmark (1)
Odense Universitetshospital, Onkologisk Afdeling R
Odense
France (1)
Centre Francois Baclesse
Caen
Guatemala (1)
Grupo Angeles
Guatemala City
Hong Kong (1)
Queen Mary Hospital
Hong Kong
Hungary (1)
Szent Margit Hospital
Budapest
Israel (1)
Shaare Zedek Medical Center
Jerusalem
Italy (1)
Ospedale San Carlo
Potenza , Basilicate
Japan (1)
Hiroshima University Hospital
Hiroshima
Mexico (1)
Centro de Investigacion
Acapulco de Juárez , Guerrero
New Zealand (1)
Auckland city hospital
Auckland
North Macedonia (1)
Private Health Organization Acibadem Sistina Hospital
Skopje
Panama (1)
The Panama Clinic
Panama City
Peru (1)
Instituto Nacional de Enfermedades Neoplasicas
Lima
Philippines (1)
Cebu Cancer Institute
Cebu City
Poland (1)
Uniwersyteckie Centrum Kliniczne
Gdansk
Russia (1)
Bashkirian Republican Clinical Oncology Dispensary
Ufa , Bashkortostan Republic
Slovenia (1)
Institute of Oncology Ljubljana
Ljubljana
South Korea (1)
Kyungpook National University Medical Center
Daegu
Spain (1)
Hospital General Universitario de Elche
Elche , Alicante
Switzerland (1)
Universitätsspital Zürich
Zurich
Taiwan (1)
Chi-Mei Medical Center
Tainan
Thailand (1)
Bumrungrad International Hosp
Bangkok
United Kingdom (1)
Ninewells Hospital
Dundee
United States (1)
City of Hope National Medical Center
Duarte , California
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
16.10.2008
Completion date
30.04.2030
Registry ID
NCT00781612
Source
anzctr
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