A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies
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|ClinicalTrials.gov Identifier: NCT00781612|
Recruitment Status : Recruiting
First Posted : October 29, 2008
Last Update Posted : February 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Neoplasm Metastasis||Drug: Docetaxel Drug: Paclitaxel Drug: Pertuzumab Drug: Trastuzumab Drug: Trastuzumab Emtansine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||720 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Multicenter Extension Study of Trastuzumab Emtansine Administered as a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd-Sponsored Trastuzumab Emtansine Study|
|Actual Study Start Date :||October 16, 2008|
|Estimated Primary Completion Date :||September 21, 2022|
|Estimated Study Completion Date :||September 21, 2022|
Experimental: Trastuzumab Emtansine
Participants will receive trastuzumab emtansine either as a single agent or in combination with other anti-cancer therapy (pertuzumab, paclitaxel, trastuzumab and docetaxel). Participants will receive the same dose and schedule on Cycle 1, Day 1 at which it was given at the end of the parent study. Study drug will be administered in 21-day cycles or weekly, depending on the schedule used in the parent study. Participants will receive study treatment until disease progression or unacceptable toxicity.
Docetaxel will be administered as per local prescribing information.Drug: Paclitaxel
Paclitaxel will be administered as per local prescribing information.Drug: Pertuzumab
Pertuzumab will be administered intravenously at a dose of 420 milligrams (mg) no more frequently than every 3 weeks (Q3W) (or as directed in the parent study protocol if less than Q3W).
Other Name: PerjetaDrug: Trastuzumab
Trastuzumab will be administered as per local prescribing information.
Other Name: HerceptinDrug: Trastuzumab Emtansine
Trastuzumab emtansine will be administered as intravenous (IV) infusion. Participants on weekly dosing schedule of trastuzumab emtansine in parent study, may switch to Q3W schedule as per the clinical judgment of the investigator. The starting dose of Q3W schedule must not exceed 3.6 milligrams per kilograms (mg/kg).
Other Name: Kadcyla; T-DM1
- Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 30 days after last dose of study drug administration (up to approximately 14 years) ]
- Percentage of Participants With Adverse Events Leading to Study Treatment Discontinuation or Dose Reduction [ Time Frame: Baseline up to 30 days after last dose of study drug administration (up to approximately 14 years) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00781612
|Contact: Reference Study ID Number: BO25430 www.roche.com/about_roche/roche_worldwide.htm||888-662-6728 (U.S. and Canada)||firstname.lastname@example.org|
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|Study Director:||Clinical Trials||Genentech, Inc.|