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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: Pertuzumab; Drug: Trastuzumab; Drug: Other Combination Anti-Cancer Therapies

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • RJ
    • Rio de Janeiro, RJ, Brazil, 20560-120
      • Instituto Nacional de Cancer - INCa; Oncologia
  • RS
    • Porto Alegre, RS, Brazil, 90020-090
      • Santa Casa de Misericordia de Porto Alegre
  • SP
    • Jau, SP, Brazil, 17210-120
      • Hospital Amaral Carvalho
    • Sao Paulo, SP, Brazil, 01246-000
      • Instituto do Cancer do Estado de Sao Paulo - ICESP
    • Sao Paulo, SP, Brazil, 01317-000
      • Hospital Perola Byington
    • Sao Paulo, SP, Brazil, 04014-002
      • Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA
    • Sao Paulo, SP, Brazil, 01308-050
      • Hospital Sírio-Libanês
    • Sorocaba, SP, Brazil, 18030-005
      • Instituto de Oncologia de Sorocaba - CEPOS
• China
  • Beijing, China, 100142
    • Beijing Cancer Hospital
  • Changchun City, China, 130021
    • The First Hospital of Jilin University
  • Chengdu, China, 610041
    • West China Hospital, Sichuan University; Department of Breast
  • Hangzhou City, China, 310022
    • Zhejiang Cancer Hospital; Breast Surgery
  • Harbin, China, 150081
    • Harbin Medical University Cancer Hospital
  • Nanjing City, China, 210029
    • Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
  • Shanghai City, China, 200120
    • Fudan University Shanghai Cancer Center
  • Shenyang, China, 110042
    • Liaoning cancer Hospital & Institute
• Costa Rica
  • San Jose, Costa Rica, 10903
    • Hospital Metropolitano (Sede Lindora-Santa Ana); Centro de Cancer
• France
  • Dijon, France, 21079
    • Centre Georges Francois Leclerc; Oncologie 3
  • Rouen, France, 76038
    • Centre Henri Becquerel; Oncologie Medicale
  • Saint Brieuc, France, 22015
    • Clinique Armoricaine Radiologie; Cons Externes
  • St Cloud, France, 92210
    • Centre Rene Huguenin; CONSULT SPECIALISEES
• Germany
  • Frankfurt am Main, Germany, 60389
    • Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus
  • Freiburg, Germany, 79110
    • Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
  • Hamburg, Germany, 20357
    • Praxis für Ambulante Onkologie im Krankenhaus Jerusalem
  • Leer, Germany, 26789
    • Studienzentrum UnterEms; Onkologische Schwerpunktpraxis Leer; Dr. med. Lothar Müller
  • Neumarkt, Germany, 92318
    • Onkologische Praxis Neumarkt (Dr. med. Ekkehart Ladda)
• Italy
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • Az. Osp. S. Orsola Malpighi; Istituto Di Oncologia Seragnoli
    • Meldola, Emilia-Romagna, Italy, 47014
      • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
    • Reggio Emilia, Emilia-Romagna, Italy, 42100
      • AUSL ? IRCCS Santa Maria Nuova; U.O. Day Hospital di Oncologia
  • Lombardia
    • Milano, Lombardia, Italy, 20141
      • Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
    • Monza, Lombardia, Italy, 20900
      • ASST DI MONZA; Oncologia Medica
  • Puglia
    • Bari, Puglia, Italy, 70124
      • Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
  • Toscana
    • Pisa, Toscana, Italy, 56100
      • A.O. Universitaria Pisana; Oncologia
• Japan
  • Chiba, Japan, 277-8577
    • National Cancer Center Hospital East; Gastroenterology
  • Gifu, Japan, 501-1194
    • Gifu University Hospital; Digestive Surgery
  • Saitama, Japan, 362-0806
    • Saitama Cancer Center; Gastroenterology
• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
• Mexico
  • Mexico City, Mexico, 14080
    • Instituto Nacional de Cancerologia; Oncology
  • Mexico City, Mexico, 03100
    • CENEIT Oncologicos; DENTRO DE CONDOMINIO SAN FRANCISCO
  • Mexico CITY (federal District)
    • D.f., Mexico CITY (federal District), Mexico, 04980
      • Iem-Fucam
  • Queretaro
    • Querétaro, Queretaro, Mexico, 76090
      • Cancerologia de Queretaro; Oncologia; Investigación
• Peru
  • Arequipa, Peru, 04001
    • Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology
  • Lima, Peru, Lima 41
    • Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
  • Lima, Peru, L27
    • Clinica Anglo Americana - Centro de Investigacion Oncologia CAA
  • Lima, Peru, 15072
    • Centro de Investigación En Oncología Y Medicina Interna de La Clínica Santa Beatriz
• Poland
  • Lublin, Poland, 20-081
    • Samodzielny Publiczny Kliniczny Nr 1 W Lublinie; Klinika Chirurgii Onkologicznej
• Portugal
  • Coimbra, Portugal, 3000-075
    • IPO de Coimbra; Servico de Oncologia Medica
  • Lisboa, Portugal, 1649-035
    • Hospital de Santa Maria; Servico de Oncologia Medica
  • Lisboa, Portugal, 1500-650
    • Hospital da Luz; Hospital de Dia Medico
  • Porto, Portugal, 4200-072
    • IPO do Porto; Servico de Oncologia Medica
• Russian Federation
  • Kursk, Russian Federation, 305035
    • Kursk Regional Clinical Oncology Dispensary
  • Samara, Russian Federation, 443031
    • SBI of Healthcare Samara Regional Clinical Oncology Dispensary
• Spain
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe; Oncologia
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
      • ICO L'Hospitalet; Servicio de oncologia medica
    • Sant Andreu de La Barca, Barcelona, Spain, 08740
      • Hospital Univ Vall d'Hebron; Servicio de Oncologia
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
  • Tenerife
    • La Laguna, Tenerife, Spain, 38320
      • Hospital Universitario de Canarias;servicio de Oncologia
  • Vizcaya
    • Bilbao, Vizcaya, Spain, 48013
      • Hospital de Basurto; Servicio de Oncologia
• Ukraine
  • Dnipropetrovsk, Ukraine, 49102
    • Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU; Chair of Oncology and Medical Radiology
  • Lviv, Ukraine, 79031
    • State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Drug: 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.; Other Names: Perjeta; RO4368451; Drug: 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.; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival		From date of first dose of pertuzumab in the Parent study until the date of disease progression or death, whichever occurs first (up to approximately 10 years)
Overall Survival		From date of first dose of pertuzumab in the Parent study until the date of death (up to approximately 10 years)
Number of Participants with Adverse Events by Severity, Classified According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03		Baseline up to approximately 10 years
Number of Participants with Adverse Events Leading to Pertuzumab Discontinuation or Dose Interruption		Baseline up to approximately 10 years
Number of Participants with Non-Serious Adverse Events of Special Interest (AESIs)	Non-serious AESIs for this study include the following: Cases of potential drug-induced liver injury that include an elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's law; Suspected transmission of an infectious agent by the study drug; or, An asymptomatic decline in left ventricular ejection fraction (LVEF) requiring treatment or leading to discontinuation of human epidermal growth factor receptor 2 (HER2)-targeted therapies.	Baseline up to approximately 10 years
Left Ventricular Ejection Fraction (LVEF) Over Time		Baseline, every 3 treatment cycles (1 cycle is 21 days), and 28 days after last dose of pertuzumab (up to approximately 10 years)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2015
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 16, 2014
• First Submitted That Met QC Criteria: December 18, 2014
• First Posted (Estimated): December 19, 2014

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antineoplastic Agents; Antineoplastic Agents, Immunological; Trastuzumab; Pertuzumab
• Other Study ID Numbers: MO29406; 2014-002048-42 (EudraCT Number)