Solid Tumors
Conditions
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.
Interventions
DRUGPertuzumab
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.
DRUGTrastuzumab
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.
DRUGOther 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.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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) | — |
Countries
Brazil, China, Costa Rica, France, Germany, Italy, Japan, Mexico, Peru, Poland, Portugal, Russia, South Korea, Spain, Ukraine
Contacts
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed