Clinical trial NCT02320435: A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Solid Tumors
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-12-19
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression-Free Survival
timeFrame: 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)
measure: Overall Survival
timeFrame: From date of first dose of pertuzumab in this study until the date of death (up to approximately 10 years)
measure: 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
timeFrame: From Baseline until 7 months after the last dose of pertuzumab (up to approximately 10 years)
measure: Number of Participants with Adverse Events Leading to Pertuzumab Discontinuation or Dose Interruption
timeFrame: From Baseline until 7 months after the last dose of pertuzumab (up to approximately 10 years)
measure: Number of Participants with Non-Serious Adverse Events of Special Interest (AESIs)
timeFrame: From Baseline until 7 months after the last dose of pertuzumab (up to approximately 10 years)
measure: Left Ventricular Ejection Fraction (LVEF) Over Time
timeFrame: Baseline, every 3 treatment cycles (1 cycle is 21 days), and 28 days after last dose of pertuzumab (up to approximately 10 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Santa Casa de Misericordia de Porto Alegre
state: Rio Grande Do Sul
city: Jau
country: Brazil
facility: Hospital Amaral Carvalho
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - ICESP
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Hospital Sírio-Libanês
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Hospital Perola Byington
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Núcleo de Pesquisa São Camilo
state: São Paulo
city: Sorocaba
country: Brazil
facility: Instituto de Oncologia de Sorocaba - CEPOS
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Cancer - INCa
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Changchun City
country: China
facility: The First Hospital of Jilin University
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Hangzhou City
country: China
facility: Zhejiang Cancer Hospital
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Nanjing City
country: China
facility: Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shenyang
country: China
facility: Liaoning cancer Hospital & Institute
city: San Jose
country: Costa Rica
facility: Hospital Metropolitano (Sede Lindora-Santa Ana)
city: Dijon
country: France
facility: Centre Georges Francois Leclerc
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint Brieuc
country: France
facility: Clinique Armoricaine Radiologie
city: St Cloud
country: France
facility: Centre Rene Huguenin
city: Frankfurt am Main
country: Germany
facility: Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus
city: Freiburg
country: Germany
facility: Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
city: Hamburg
country: Germany
facility: Praxis für Ambulante Onkologie im Krankenhaus Jerusalem
city: Leer
country: Germany
facility: Studienzentrum UnterEms;Onkologische Schwerpunktpraxis Leer
city: Neumarkt
country: Germany
facility: Onkologische Praxis Neumarkt (Dr. med. Ekkehart Ladda)
city: Bologna
country: Italy
facility: Az. Osp. S. Orsola Malpighi
state: Emilia-Romagna
city: Meldola
country: Italy
facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
state: Emilia-Romagna
city: Reggio Emilia
country: Italy
facility: AUSL ? IRCCS Santa Maria Nuova
state: Emilia-Romagna
city: Milano
country: Italy
facility: Irccs Istituto Europeo Di Oncologia (IEO)
state: Lombardia
city: Monza
country: Italy
facility: Asst Di Monza
state: Lombardia
city: Bari
country: Italy
facility: Irccs Ist. Tumori Giovanni Paolo Ii
state: Puglia
city: Pisa
country: Italy
facility: A.O. Universitaria Pisana
state: Toscana
city: Chiba
country: Japan
facility: National Cancer Center Hospital East
city: Gifu
country: Japan
facility: Gifu University Hospital
city: Saitama
country: Japan
facility: Saitama Cancer Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: D.f.
country: Mexico
facility: Iem-Fucam
state: Mexico CITY (federal District)
city: Querétaro
country: Mexico
facility: Cancerologia de Queretaro
state: Queretaro
city: Distrito Federal
country: Mexico
facility: Instituto Nacional de Cancerologia
city: Mexico City
country: Mexico
facility: CENEIT Oncologicos
city: Arequipa
country: Peru
facility: Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud
city: Lima
country: Peru
facility: Clinica Anglo Americana - Centro de Investigacion Oncologia CAA
city: Lima
country: Peru
facility: Clinica Internacional, Sede San Borja
city: Lublin
country: Poland
facility: Samodzielny Publiczny Kliniczny Nr 1 W Lublinie
city: Coimbra
country: Portugal
facility: IPO de Coimbra
city: Lisboa
country: Portugal
facility: Hospital da Luz
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria
city: Porto
country: Portugal
facility: IPO do Porto
city: Kursk
country: Russian Federation
facility: Kursk Regional Clinical Oncology Dispensary
city: Samara
country: Russian Federation
facility: SBI of Healthcare Samara Regional Clinical Oncology Dispensary
city: L'Hospitalet de Llobregat
country: Spain
facility: ICO L'Hospitalet
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Tenerife
city: Bilbao
country: Spain
facility: Hospital de Basurto
state: Vizcaya
city: Barcelona
country: Spain
facility: Vall d'Hebron Institute of Oncology (VHIO), Barcelona
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Dnipropetrovsk
country: Ukraine
facility: Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU
city: Lviv
country: Ukraine
facility: State Oncology Regional Treatment-Diagnostic Center
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: