A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02320435|
Recruitment Status : Recruiting
First Posted : December 19, 2014
Last Update Posted : September 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Drug: Pertuzumab Drug: Trastuzumab Drug: Other Combination Anti-Cancer Therapies||Phase 3|
|Study Type :||Interventional|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||February 2, 2015|
|Estimated Primary Completion Date :||May 31, 2024|
|Estimated Study Completion Date :||May 31, 2024|
Experimental: Pertuzumab (Single-Agent or Combination Therapy)
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.
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.
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.
Drug: 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.
- Progression-Free Survival [ Time Frame: 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) ]
- Overall Survival [ Time Frame: From date of first dose of pertuzumab in the Parent 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 [ Time Frame: Baseline up to approximately 10 years ]
- Number of Participants with Adverse Events Leading to Pertuzumab Discontinuation or Dose Interruption [ Time Frame: Baseline up to approximately 10 years ]
- Number of Participants with Non-Serious Adverse Events of Special Interest (AESIs) [ Time Frame: Baseline 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 [ Time Frame: Baseline, every 3 treatment cycles (1 cycle is 21 days), and 28 days after last dose of pertuzumab (up to approximately 10 years) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02320435
|Contact: Reference Study ID Number: MO29406 www.roche.com/about_roche/roche_worldwide.htm||888-662-6728 (U.S. and Canada)||email@example.com|
|Study Director:||Clinical Trials||Hoffmann-La Roche|