A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
NCT ID: NCT02320435
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
154 participants
INTERVENTIONAL
2015-02-02
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pertuzumab (Single-Agent or Combination Therapy)
Pertuzumab will continue to be administered as a single agent or in combination with other anti-cancer therapies at the same dose, schedule, and guidelines that were in effect at the end of the Parent study.
Pertuzumab
In general, patients will continue to receive 420 milligrams (mg) of pertuzumab administered as an intravenous infusion every 3 weeks following the guidance of the Parent protocol.
Trastuzumab
If trastuzumab intravenous infusions were given in combination with pertuzumab as part of the Parent study, patients will continue to receive treatment at the same dose, schedule and under the same administration guidelines which were in effect at the time of Parent study closure.
Other Combination Anti-Cancer Therapies
If other anti-cancer therapies were given in combination with pertuzumab as part of the Parent study, patients will receive all treatments at the same dose, schedule and under the same administration guidelines which were in effect at the time of Parent study closure.
Interventions
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Pertuzumab
In general, patients will continue to receive 420 milligrams (mg) of pertuzumab administered as an intravenous infusion every 3 weeks following the guidance of the Parent protocol.
Trastuzumab
If trastuzumab intravenous infusions were given in combination with pertuzumab as part of the Parent study, patients will continue to receive treatment at the same dose, schedule and under the same administration guidelines which were in effect at the time of Parent study closure.
Other Combination Anti-Cancer Therapies
If other anti-cancer therapies were given in combination with pertuzumab as part of the Parent study, patients will receive all treatments at the same dose, schedule and under the same administration guidelines which were in effect at the time of Parent study closure.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prior eligibility for, and receiving pertuzumab as an investigational medicinal product in, a Roche-sponsored study (either as a single agent or in combination with other anti-cancer drugs used in the Parent study) at the time of the Parent study closure
* Investigator's opinion that the patient continues to benefit from treatment
Exclusion Criteria
* Permanent discontinuation of pertuzumab for any reason during the Parent study, or between the end of the Parent study and before enrollment into the extension study
* Any unresolved or irreversible toxicities during the Parent study that require permanent discontinuation of pertuzumab, according to Parent protocol or local label. Delay of treatment to wait for resolution of toxicities is allowed as long as it is within the guidelines of the respective Parent protocol and does not contradict exclusion criterion below.
* More than 9 weeks between the last dose of pertuzumab in the Parent study and the first dose pertuzumab in the extension study
* Left ventricular ejection fraction \</= 50%
* Any serious uncontrolled concomitant disease that would contraindicate the use of pertuzumab or that would put the patient at high risk for treatment-related complications
* Treatment with any anti-cancer treatment (other than any treatment given as permitted in the Parent protocol) in the time period between last treatment in the Parent study and the first dose pertuzumab in the extension study (i.e. up to 9 weeks)
* Positive serum pregnancy test
* Women of child-bearing potential and men with partners of childbearing potential who do not agree to use a highly-effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by the patient and/or partner for the duration of study treatment and for at least 7 months after the last dose of study medication. Male patients who do not agree to refrain from donating sperm during this same period. Male patients whose partner is pregnant who do not agree to use condoms for the duration of the pregnancy.
* Concurrent participation in any therapeutic clinical trial (other than the Parent study)
* Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Amaral Carvalho
Jaú, São Paulo, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, Brazil
Hospital Sírio-Libanês
São Paulo, São Paulo, Brazil
Hospital Perola Byington
São Paulo, São Paulo, Brazil
Núcleo de Pesquisa São Camilo
São Paulo, São Paulo, Brazil
Instituto de Oncologia de Sorocaba - CEPOS
Sorocaba, São Paulo, Brazil
Instituto Nacional de Cancer - INCa
Rio de Janeiro, , Brazil
Beijing Cancer Hospital
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
West China Hospital, Sichuan University
Chengdu, , China
Zhejiang Cancer Hospital
Hangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
Nanjing, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Liaoning cancer Hospital & Institute
Shenyang, , China
Hospital Metropolitano (Sede Lindora-Santa Ana)
San José, , Costa Rica
Centre Georges Francois Leclerc
Dijon, , France
Centre Henri Becquerel
Rouen, , France
Clinique Armoricaine Radiologie
Saint-Brieuc, , France
Centre Rene Huguenin
Saint-Cloud, , France
Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus
Frankfurt am Main, , Germany
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
Freiburg im Breisgau, , Germany
Praxis für Ambulante Onkologie im Krankenhaus Jerusalem
Hamburg, , Germany
Studienzentrum UnterEms;Onkologische Schwerpunktpraxis Leer
Leer, , Germany
Onkologische Praxis Neumarkt (Dr. med. Ekkehart Ladda)
Neumarkt, , Germany
Irccs Ist. Tumori Giovanni Paolo Ii
Bari, Apulia, Italy
Az. Osp. S. Orsola Malpighi
Bologna, Emilia-Romagna, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
Meldola, Emilia-Romagna, Italy
AUSL ? IRCCS Santa Maria Nuova
Reggio Emilia, Emilia-Romagna, Italy
Irccs Istituto Europeo Di Oncologia (IEO)
Milan, Lombardy, Italy
Asst Di Monza
Monza, Lombardy, Italy
A.O. Universitaria Pisana
Pisa, Tuscany, Italy
National Cancer Center Hospital East
Chiba, , Japan
Gifu University Hospital
Gifu, , Japan
Saitama Cancer Center
Saitama, , Japan
Iem-Fucam
D.F., Mexico CITY (federal District), Mexico
Cancerologia de Queretaro
Querétaro City, Querétaro, Mexico
Instituto Nacional de Cancerologia
Distrito Federal, , Mexico
Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud
Arequipa, , Peru
Clinica Anglo Americana - Centro de Investigacion Oncologia CAA
Lima, , Peru
Clinica Internacional, Sede San Borja
Lima, , Peru
Samodzielny Publiczny Kliniczny Nr 1 W Lublinie
Lublin, , Poland
IPO de Coimbra
Coimbra, , Portugal
Hospital da Luz
Lisbon, , Portugal
Hospital de Santa Maria
Lisbon, , Portugal
IPO do Porto
Porto, , Portugal
Kursk Regional Clinical Oncology Dispensary
Kursk, , Russia
SBI of Healthcare Samara Regional Clinical Oncology Dispensary
Samara, , Russia
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
ICO L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, Spain
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU
Dnipropetrovsk, , Ukraine
State Oncology Regional Treatment-Diagnostic Center
Lviv, , Ukraine
Countries
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Other Identifiers
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2014-002048-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-505102-42-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
MO29406
Identifier Type: -
Identifier Source: org_study_id