Open-Label Study Evaluating the Safety and Tolerability of LJM716, BYL719 and Trastuzumab in Patients With Metastatic HER2+ Breast Cancer
This is a Phase I study. The purpose of this study is to determine what is the best dose of the study drug BYL719 in combination with the study drug LJM716 and traztuzumab (Herceptin®). The study will test the safety of the combination of these three drugs, and to find out the effects, good and/or bad, that these three drugs have on the patient and breast cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I, Open-Label Study Evaluating the Safety and Tolerability of LJM716, BYL719 and Trastuzumab in Patients With Metastatic HER2+ Breast Cancer|
- maximum tolerated dose (MTD) of BYL719 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Toxicity will be assessed using the NCI Common Toxicity Criteria, version 4.0, unless otherwise specified. The type, severity, timing and relationship of each adverse event will be documented. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2014|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Experimental: LJM716, BYL719 AND TRASTUZUMAB
The length of each treatment cycle will be 28 days. During the dose escalation phase, BYL719 will be administered as an oral medication, daily throughout each 28 day treatment cycle. BYL719 will be dose escalated until MTD is defined.
Trastuzumab (T) will be given as a weekly intravenous infusion, starting with a loading dose (if deemed clinically appropriate) of 4mg/ kg, subsequently to be followed by weekly infusions of 2mg/kg. LJM716 (L) will be administered as a weekly intravenous infusion at a dose of 20mg/kg.
All patients will remain on treatment unless and until criteria for remova.
|Drug: BYL719 Drug: LJM716 Drug: TRASTUZUMAB|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02167854
|Contact: Shanu Modi, MD||646-888-5243|
|Contact: Maura Dickler, MD||646-888-5456|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Shanu Modi, MD 646-888-5243|
|Contact: Maura Dickler, MD 646-888-5456|
|Principal Investigator: Shanu Modi, MD|
|Principal Investigator:||Shanu Modi, MD||Memorial Sloan-Kettering Cancer Center|