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

Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02320435
• Other study ID #: MO29406
• Secondary ID: 2014-002048-42
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: February 2, 2015
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 154
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Solid Tumor

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	Hospital Amaral Carvalho	Jau	SP
Brazil	Santa Casa de Misericordia de Porto Alegre	Porto Alegre	RS
Brazil	Instituto Nacional de Cancer - INCa; Oncologia	Rio de Janeiro	RJ
Brazil	Hospital Perola Byington	Sao Paulo	SP
Brazil	Hospital Sírio-Libanês	Sao Paulo	SP
Brazil	Instituto do Cancer do Estado de Sao Paulo - ICESP	Sao Paulo	SP
Brazil	Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA	Sao Paulo	SP
Brazil	Instituto de Oncologia de Sorocaba - CEPOS	Sorocaba	SP
China	Beijing Cancer Hospital	Beijing
China	The First Hospital of Jilin University	Changchun City
China	West China Hospital, Sichuan University; Department of Breast	Chengdu
China	Zhejiang Cancer Hospital; Breast Surgery	Hangzhou 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 City
China	Liaoning cancer Hospital & Institute	Shenyang
Costa Rica	Hospital Metropolitano (Sede Lindora-Santa Ana); Centro de Cancer	San Jose
France	Centre Georges Francois Leclerc; Oncologie 3	Dijon
France	Centre Henri Becquerel; Oncologie Medicale	Rouen
France	Clinique Armoricaine Radiologie; Cons Externes	Saint Brieuc
France	Centre Rene Huguenin; CONSULT SPECIALISEES	St Cloud
Germany	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	Studienzentrum UnterEms; Onkologische Schwerpunktpraxis Leer; Dr. med. Lothar Müller	Leer
Germany	Onkologische Praxis Neumarkt (Dr. med. Ekkehart Ladda)	Neumarkt
Italy	Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica	Bari	Puglia
Italy	Az. Osp. S. Orsola Malpighi; Istituto Di Oncologia Seragnoli	Bologna	Emilia-Romagna
Italy	IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica	Meldola	Emilia-Romagna
Italy	Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica	Milano	Lombardia
Italy	ASST DI MONZA; Oncologia Medica	Monza	Lombardia
Italy	A.O. Universitaria Pisana; Oncologia	Pisa	Toscana
Italy	AUSL ? IRCCS Santa Maria Nuova; U.O. Day Hospital di Oncologia	Reggio Emilia	Emilia-Romagna
Japan	National Cancer Center Hospital East; Gastroenterology	Chiba
Japan	Gifu University Hospital; Digestive Surgery	Gifu
Japan	Saitama Cancer Center; Gastroenterology	Saitama
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Mexico	Iem-Fucam	D.f.	Mexico CITY (federal District)
Mexico	CENEIT Oncologicos; DENTRO DE CONDOMINIO SAN FRANCISCO	Mexico City
Mexico	Instituto Nacional de Cancerologia; Oncology	Mexico City
Mexico	Cancerologia de Queretaro; Oncologia; Investigación	Querétaro	Queretaro
Peru	Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology	Arequipa
Peru	Centro de Investigación En Oncología Y Medicina Interna de La Clínica Santa Beatriz	Lima
Peru	Clinica Anglo Americana - Centro de Investigacion Oncologia CAA	Lima
Peru	Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional	Lima
Poland	Samodzielny Publiczny Kliniczny Nr 1 W Lublinie; Klinika Chirurgii Onkologicznej	Lublin
Portugal	IPO de Coimbra; Servico de Oncologia Medica	Coimbra
Portugal	Hospital da Luz; Hospital de Dia Medico	Lisboa
Portugal	Hospital de Santa Maria; Servico de Oncologia Medica	Lisboa
Portugal	IPO do Porto; Servico de Oncologia Medica	Porto
Russian Federation	Kursk Regional Clinical Oncology Dispensary	Kursk
Russian Federation	SBI of Healthcare Samara Regional Clinical Oncology Dispensary	Samara
Spain	Hospital de Basurto; Servicio de Oncologia	Bilbao	Vizcaya
Spain	ICO L'Hospitalet; Servicio de oncologia medica	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Universitario de Canarias;servicio de Oncologia	La Laguna	Tenerife
Spain	Hospital Univ Vall d'Hebron; Servicio de Oncologia	Sant Andreu de La Barca	Barcelona
Spain	Hospital Universitario Marques de Valdecilla; Servicio de Oncologia	Santander	Cantabria
Spain	Hospital Universitari i Politecnic La Fe; Oncologia	Valencia
Ukraine	Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU; Chair of Oncology and Medical Radiology	Dnipropetrovsk
Ukraine	State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department	Lviv

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Brazil,  China,  Costa Rica,  France,  Germany,  Italy,  Japan,  Korea, Republic of,  Mexico,  Peru,  Poland,  Portugal,  Russian Federation,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Overall Survival		From date of first dose of pertuzumab in the Parent study until the date of death (up to approximately 10 years)
Primary	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
Primary	Number of Participants with Adverse Events Leading to Pertuzumab Discontinuation or Dose Interruption		Baseline up to approximately 10 years
Primary	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
Primary	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)