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

NCT02320435 | Active Not Recruiting Phase 3 FDA Drug

• 3 other identifiers: MO294062014-002048-422023-505102-42-00
• Study Type: interventional
• Target: 154
• Locations: 15 countries
• Sites: 61

Brief 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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (6)

• Progression-Free Survival

  From date of first dose of pertuzumab in this 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 this 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

  From Baseline until 7 months after the last dose of pertuzumab (up to approximately 10 years)

• Number of Participants with Adverse Events Leading to Pertuzumab Discontinuation or Dose Interruption

  From Baseline until 7 months after the last dose of pertuzumab (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.

  From Baseline until 7 months after the last dose of pertuzumab (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)

Study Arms (1)

Pertuzumab (Single-Agent or Combination Therapy)

EXPERIMENTAL

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; Drug: Trastuzumab; Drug: Other Combination Anti-Cancer Therapies

Interventions

Pertuzumab DRUG

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.

Also known as: RO4368451, Perjeta

Pertuzumab (Single-Agent or Combination Therapy)

Trastuzumab DRUG

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.

Pertuzumab (Single-Agent or Combination Therapy)

Other Combination Anti-Cancer Therapies DRUG

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.

Pertuzumab (Single-Agent or Combination Therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (61)

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

Location

Hospital Amaral Carvalho

Jaú, São Paulo, 17210-080, Brazil

Location

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo, 01246-000, Brazil

Location

Hospital Sírio-Libanês

São Paulo, São Paulo, 01308-050, Brazil

Location

Hospital Perola Byington

São Paulo, São Paulo, 01317-000, Brazil

Location

Núcleo de Pesquisa São Camilo

São Paulo, São Paulo, 04014-002, Brazil

Location

Instituto de Oncologia de Sorocaba - CEPOS

Sorocaba, São Paulo, 18030-005, Brazil

Location

Instituto Nacional de Cancer - INCa

Rio de Janeiro, 20560-120, Brazil

Location

Beijing Cancer Hospital

Beijing, 100142, China

Location

The First Hospital of Jilin University

Changchun, 130021, China

Location

West China Hospital, Sichuan University

Chengdu, 610041, China

Location

Zhejiang Cancer Hospital

Hangzhou, 310022, China

Location

Harbin Medical University Cancer Hospital

Harbin, 150081, China

Location

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

Nanjing, 210029, China

Location

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

Fudan University Shanghai Cancer Center

Shanghai, 200120, China

Location

Liaoning cancer Hospital & Institute

Shenyang, 110042, China

Location

Hospital Metropolitano (Sede Lindora-Santa Ana)

San José, 10903, Costa Rica

Location

Centre Georges Francois Leclerc

Dijon, 21079, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Clinique Armoricaine Radiologie

Saint-Brieuc, 22015, France

Location

Centre Rene Huguenin

Saint-Cloud, 92210, France

Location

Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus

Frankfurt am Main, 60389, Germany

Location

Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

Freiburg im Breisgau, 79110, Germany

Location

Praxis für Ambulante Onkologie im Krankenhaus Jerusalem

Hamburg, 20357, Germany

Location

Studienzentrum UnterEms;Onkologische Schwerpunktpraxis Leer

Leer, 26789, Germany

Location

Onkologische Praxis Neumarkt (Dr. med. Ekkehart Ladda)

Neumarkt, 92318, Germany

Location

Irccs Ist. Tumori Giovanni Paolo Ii

Bari, Apulia, 70124, Italy

Location

Az. Osp. S. Orsola Malpighi

Bologna, Emilia-Romagna, 40138, Italy

Location

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

Meldola, Emilia-Romagna, 47014, Italy

Location

AUSL ? IRCCS Santa Maria Nuova

Reggio Emilia, Emilia-Romagna, 42100, Italy

Location

Irccs Istituto Europeo Di Oncologia (IEO)

Milan, Lombardy, 20141, Italy

Location

Asst Di Monza

Monza, Lombardy, 20052, Italy

Location

A.O. Universitaria Pisana

Pisa, Tuscany, 56100, Italy

Location

National Cancer Center Hospital East

Chiba, 277-8577, Japan

Location

Gifu University Hospital

Gifu, 501-1194, Japan

Location

Saitama Cancer Center

Saitama, 362-0806, Japan

Location

Iem-Fucam

D.F., Mexico CITY (federal District), 04980, Mexico

Location

Cancerologia de Queretaro

Querétaro City, Querétaro, 76090, Mexico

Location

Instituto Nacional de Cancerologia

Distrito Federal, 14080, Mexico

Location

Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud

Arequipa, 04001, Peru

Location

Clinica Anglo Americana - Centro de Investigacion Oncologia CAA

Lima, L27, Peru

Location

Clinica Internacional, Sede San Borja

Lima, Lima 41, Peru

Location

Samodzielny Publiczny Kliniczny Nr 1 W Lublinie

Lublin, 20-081, Poland

Location

IPO de Coimbra

Coimbra, 3000-075, Portugal

Location

Hospital da Luz

Lisbon, 1500-650, Portugal

Location

Hospital de Santa Maria

Lisbon, 1649-035, Portugal

Location

IPO do Porto

Porto, 4200-072, Portugal

Location

Kursk Regional Clinical Oncology Dispensary

Kursk, 305035, Russia

Location

SBI of Healthcare Samara Regional Clinical Oncology Dispensary

Samara, 443031, Russia

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

ICO L'Hospitalet

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Tenerife, 38320, Spain

Location

Hospital de Basurto

Bilbao, Vizcaya, 48013, Spain

Location

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

Barcelona, 08035, Spain

Location

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

Location

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

Dnipropetrovsk, 49102, Ukraine

Location

State Oncology Regional Treatment-Diagnostic Center

Lviv, 79031, Ukraine

Location

MeSH Terms

Interventions

pertuzumab; Trastuzumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: December 19, 2014
• Study Start: February 2, 2015
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

PT (4); CO (1); ME (3); UA (2); JP (3); KR (3); RU (2); ES (6); PL (1); CN (9); DE (5); BR (8); FR (4); PE (3); IT (7)