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

Phase 3

Active, not recruiting

• Conditions: Solid Tumors
• Interventions: Drug: Pertuzumab; Drug: Trastuzumab; Drug: Other Combination Anti-Cancer Therapies

• Registration Number: NCT02320435
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-16
• Study First Submitted QC: 2014-12-18
• Study First Posted: 2014-12-19
• Study Start: 2015-02-02
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-21
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 154

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pertuzumab (Single-Agent or Combination Therapy)	Other Combination Anti-Cancer Therapies	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 (Single-Agent or Combination Therapy)	Pertuzumab	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 (Single-Agent or Combination Therapy)	Trastuzumab	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.

Primary Outcome Measures

Name	Time	Method
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)
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 Non-Serious Adverse Events of Special Interest (AESIs)	From Baseline until 7 months after the last dose of pertuzumab (up to approximately 10 years)	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.
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)

Trial Locations

Locations (61)

Núcleo de Pesquisa São Camilo; 🇧🇷 Sao Paulo, São Paulo, Brazil

Instituto Nacional de Cancer - INCa; 🇧🇷 Rio de Janeiro, Brazil

West China Hospital, Sichuan University; 🇨🇳 Chengdu, China

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou City, China

Hospital Metropolitano (Sede Lindora-Santa Ana); 🇨🇷 San Jose, Costa Rica

Centre Georges Francois Leclerc; 🇫🇷 Dijon, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

Clinique Armoricaine Radiologie; 🇫🇷 Saint Brieuc, France

Centre Rene Huguenin; 🇫🇷 St Cloud, France

Studienzentrum UnterEms;Onkologische Schwerpunktpraxis Leer; 🇩🇪 Leer, Germany

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); 🇮🇹 Milano, Lombardia, Italy

Asst Di Monza; 🇮🇹 Monza, Lombardia, Italy

Irccs Ist. Tumori Giovanni Paolo Ii; 🇮🇹 Bari, Puglia, Italy

A.O. Universitaria Pisana; 🇮🇹 Pisa, Toscana, Italy

Gifu University Hospital; 🇯🇵 Gifu, Japan

Saitama Cancer Center; 🇯🇵 Saitama, Japan

Cancerologia de Queretaro; 🇲🇽 Querétaro, Queretaro, Mexico

Instituto Nacional de Cancerologia; 🇲🇽 Distrito Federal, Mexico

CENEIT Oncologicos; 🇲🇽 Mexico City, Mexico

Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; 🇵🇪 Arequipa, 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; 🇵🇹 Lisboa, Portugal

Hospital de Santa Maria; 🇵🇹 Lisboa, Portugal

IPO do Porto; 🇵🇹 Porto, Portugal

ICO L'Hospitalet; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario Marques de Valdecilla; 🇪🇸 Santander, Cantabria, Spain

Hospital Universitario de Canarias; 🇪🇸 La Laguna, Tenerife, Spain

Hospital de Basurto; 🇪🇸 Bilbao, Vizcaya, 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

Santa Casa de Misericordia de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Hospital Amaral Carvalho; 🇧🇷 Jau, São Paulo, Brazil

Instituto do Cancer do Estado de Sao Paulo - ICESP; 🇧🇷 Sao Paulo, São Paulo, Brazil

Hospital Sírio-Libanês; 🇧🇷 Sao Paulo, São Paulo, Brazil

Hospital Perola Byington; 🇧🇷 Sao Paulo, São Paulo, Brazil

Instituto de Oncologia de Sorocaba - CEPOS; 🇧🇷 Sorocaba, São Paulo, Brazil

Beijing Cancer Hospital; 🇨🇳 Beijing, China

The First Hospital of Jilin University; 🇨🇳 Changchun City, China

Harbin Medical University Cancer Hospital; 🇨🇳 Harbin, China

Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University); 🇨🇳 Nanjing City, China

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China

Liaoning cancer Hospital & Institute; 🇨🇳 Shenyang, China

Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus; 🇩🇪 Frankfurt am Main, Germany

Praxis für Interdisziplinäre Onkologie und Hämatologie GbR; 🇩🇪 Freiburg, Germany

Praxis für Ambulante Onkologie im Krankenhaus Jerusalem; 🇩🇪 Hamburg, Germany

Onkologische Praxis Neumarkt (Dr. med. Ekkehart Ladda); 🇩🇪 Neumarkt, Germany

National Cancer Center Hospital East; 🇯🇵 Chiba, Japan

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Iem-Fucam; 🇲🇽 D.f., Mexico CITY (federal District), Mexico

Clinica Anglo Americana - Centro de Investigacion Oncologia CAA; 🇵🇪 Lima, Peru

Kursk Regional Clinical Oncology Dispensary; 🇷🇺 Kursk, Russian Federation

SBI of Healthcare Samara Regional Clinical Oncology Dispensary; 🇷🇺 Samara, Russian Federation