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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Primary outcome measure(s)

• 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)

Trial sites (62)

+ 22 more sites — see the full list on the official registry below.

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