48
Participants
Start Date
July 26, 2013
Primary Completion Date
June 3, 2016
Study Completion Date
June 3, 2016
LJM716
LJM716 (10-40 mg/kg) will be given as a once weekly infusion beginning on cycle 1 day 1. The doses of LJM716 will be increased as dose escalation proceeds until a maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) is established.
BYL719
BYL719 (200-400 mg) will be administered orally on a once daily schedule starting cycle 1 day 1. The doses of BYL719 will be increased as dose escalation proceeds until a maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) is established.
Paclitaxel
In the Phase II portion of the study Paclitaxel is one of the 3 physician's choice drug which allows single-agent paclitaxel to be used per manufacturer's label.
Docetaxel
In the Phase II portion of the study Docetaxel is one of the 3 physician's choice drug which allows single-agent docetaxel to be used per manufacturer's label.
Irinotecan
In the Phase II portion of the study Irinotecan is one of the 3 physician's choice drug which allows single-agent irinotecan to be used per manufacturer's label
Novartis Investigative Site, Brussels
Novartis Investigative Site, Taipei
Karmanos Cancer Institute Dept of Onc, Detroit
University of Chicago Medical Center Dept of Onc, Chicago
Novartis Investigative Site, Tainan City
Novartis Investigative Site, Singapore
University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology, Houston
Novartis Investigative Site, Toronto
Novartis Investigative Site, Hong Kong
Novartis Investigative Site, Seoul
Novartis Investigative Site, Seoul
Novartis Investigative Site, Barcelona
Novartis Investigative Site, Manchester
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY