A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial

  • Cancer
  • Solid Tumors
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Active, not recruiting

This trial runs in
Countries
  • Brazil
  • China
  • Costa Rica
  • France
  • Germany
  • Italy
  • Japan
  • Mexico
  • Peru
  • Poland
  • Portugal
  • Russia
  • South Korea
  • Spain
  • Ukraine
Trial Identifier:

NCT02320435 2014-002048-42 2023-505102-42-00 MO29406

  • Instituto Nacional de Cancer - INCa; Oncologia

    20560-121Rio de JaneiroBrazil
  • Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA

    04113-001São PauloBrazil
  • Beijing Cancer Hospital

    100142bei-jing-shiChina
  • The First Hospital of Jilin University

    130021chang-chun-shiChina
  • Harbin Medical University Cancer Hospital

    150081HarbinChina
  • Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

    210029nan-jing-shiChina
  • Liaoning cancer Hospital & Institute

    110042shen-yang-shiChina
  • Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus

    60389Frankfurt am MainGermany
  • Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

    79110Freiburg im BreisgauGermany
  • Praxis für Ambulante Onkologie im Krankenhaus Jerusalem

    20357HamburgGermany
  • Onkologische Praxis Neumarkt (Dr. med. Ekkehart Ladda)

    92318Neumarkt in der OberpfalzGermany
  • National Cancer Center Hospital East

    277-8577KashiwaJapan
  • Seoul National University Hospital

    03080SeoulSouth Korea
  • Severance Hospital, Yonsei University Health System

    03722SeoulSouth Korea
  • Asan Medical Center

    05505SeoulSouth Korea
  • Iem-Fucam

    04650Ciudad de MéxicoMexico
  • Clinica Anglo Americana - Centro de Investigacion Oncologia CAA

    L27LimaPeru
  • Kursk Regional Clinical Oncology Dispensary

    305016KurskRussia
  • SBI of Healthcare Samara Regional Clinical Oncology Dispensary

    443031SamaraRussia
  • Santa Casa de Misericordia de Porto Alegre

    90020-090Rio Grande do SulBrazil
  • Hospital Amaral Carvalho

    17210-070São PauloBrazil
  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    01246-000São PauloBrazil
  • Hospital Sírio-Libanês

    01308-050São PauloBrazil
  • Hospital Perola Byington

    01215-000São PauloBrazil
  • Núcleo de Pesquisa São Camilo

    04263-200São PauloBrazil
  • Instituto de Oncologia de Sorocaba - CEPOS

    18030-005São PauloBrazil
  • Instituto Nacional de Cancer - INCa

    20560-120Rio de JaneiroBrazil
  • West China Hospital, Sichuan University

    610041Cheng Du ShiChina
  • Zhejiang Cancer Hospital

    310022hang-zhou-shiChina
  • Fudan University Shanghai Cancer Center

    200032shang-hai-shiChina
  • Fudan University Shanghai Cancer Center

    200032shang-hai-shiChina
  • Hospital Metropolitano (Sede Lindora-Santa Ana)

    10903Santa AnaCosta Rica
  • Centre Georges Francois Leclerc

    21000DijonFrance
  • Centre Henri Becquerel

    76038RouenFrance
  • Clinique Armoricaine Radiologie

    22190PlérinFrance
  • Centre Rene Huguenin

    92210Saint-CloudFrance
  • Studienzentrum UnterEms;Onkologische Schwerpunktpraxis Leer

    26789Leer (Ostfriesland)Germany
  • Az. Osp. S. Orsola Malpighi

    40138BolognaItaly
  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola

    47014MeldolaItaly
  • AUSL ? IRCCS Santa Maria Nuova

    42123Reggio EmiliaItaly
  • Irccs Istituto Europeo Di Oncologia (IEO)

    20141LombardiaItaly
  • Asst Di Monza

    20900MonzaItaly
  • Irccs Ist. Tumori Giovanni Paolo Ii

    70124BariItaly
  • A.O. Universitaria Pisana

    56124PisaItaly
  • Gifu University Hospital

    501-1112GifuJapan
  • Saitama Cancer Center

    362-0806InaJapan
  • Cancerologia de Queretaro

    76178Santiago de QuerétaroMexico
  • Instituto Nacional de Cancerologia

    14080Ciudad de MéxicoMexico
  • CENEIT Oncologicos

    03100Ciudad de MéxicoMexico
  • Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud

    04001ArequipaPeru
  • Clinica Internacional, Sede San Borja

    15036LimaPeru
  • Samodzielny Publiczny Kliniczny Nr 1 W Lublinie

    20-400LublinPoland
  • IPO de Coimbra

    3000-075CoimbraPortugal
  • Hospital da Luz

    1500-650LisboaPortugal
  • Hospital de Santa Maria

    1649-028LisboaPortugal
  • IPO do Porto

    4200-072PortoPortugal
  • ICO L'Hospitalet

    08908L'Hospitalet de LlobregatSpain
  • Hospital Universitario Marques de Valdecilla

    39008SantanderSpain
  • Hospital Universitario de Canarias

    38320La LagunaSpain
  • Hospital de Basurto

    48013BilboSpain
  • Vall d'Hebron Institute of Oncology (VHIO), Barcelona

    08035BarcelonaSpain
  • Hospital Universitari i Politecnic La Fe

    46026ValènciaSpain
  • Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU

    49044DniproUkraine
  • State Oncology Regional Treatment-Diagnostic Center

    79000LvivUkraine
    Show trial locations

    The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

    The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

    Results Disclaimer

    Trial Summary

    This is a single-arm, multi-center, open-label extension study designed to provide continued pertuzumab therapy to patients receiving pertuzumab as an investigational medicinal product (IMP) in a Roche-sponsored global study and who continue to receive pertuzumab at the end of the Parent study, as well as to collect long-term safety and efficacy data of pertuzumab therapy. Patients with solid tumors who have not experienced progressive disease in the Parent study and, in the investigator's opinion, may potentially benefit from continued pertuzumab treatment, will continue to receive pertuzumab until disease progression, unacceptable toxicity, investigator/patient decision, patient non-compliance, patient death, patient request to withdraw, or study termination by the Sponsor, whichever occurs first.

    Hoffmann-La Roche Sponsor
    Phase 3 Phase
    NCT02320435, MO29406, 2014-002048-42,2023-505102-42-00 Trial Identifier
    Pertuzumab, Trastuzumab, Other Combination Anti-Cancer Therapies Treatments
    Solid Tumor Condition
    Official Title

    A Single-Arm Open-Label Multi-Centre Extension Study of Pertuzumab Administered As a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Study

    Eligibility Criteria

    All Gender
    ≥18 Years Age
    No Healthy Volunteers
    Inclusion Criteria
    • Informed consent
    • 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
    • Meets any of the exclusion criteria of the Parent protocol at the time the patient is considered for entry in the extension study
    • Evidence of disease progression assessed according to Parent protocol before enrollment in to the extension study
    • 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

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