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NCT02320435

PHASE3

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

154

Start Date

2015-02-02

Completion Date

2026-12-31

Last Updated

2026-02-12

Healthy Volunteers

Conditions

Solid Tumors

Interventions

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.

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.

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

Locations (59)

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (59)