Page 113 - MBCA_FULL REPORT_FINAL_FOR_WEB

Appendix 1: Clinical Trials Analyzed

Study Drug(s) Target Biomarkers/ Combination Sponsor
Subtype
1. Sustaining Prolif-
erative Signaling
PI3/Akt/mTOR BKM120 PI3 TripleNegative SOLTI Breast Cancer Research
Group
BKM120 PI3 HER2- BKM120/paclitaxel vs. Novartis
BKM120/placebo
BKM120 PI3 Hormone+_HER2- Fulvestrant Novartis
BKM120 PI3 Hormone+_HER2- Fulvestrant Novartis
BKM120 PI3 All Capecitabine Novartis
BKM120, olaparib PI3K TripleNegative Dana-Farber/Harvard Cancer
Center
GDC-0032 PI3 Hormone+ Fulvestrant Genentech
GDC-0032 PI3 HER2- Docetaxel or pacli- Genentech
taxel
Active, not recruiting GDC-0941 PI3 Hormone+_HER2- Paclitaxel Genentech
GDC-0941 P13 TripleNegative Cisplatin Vanderbilt-Ingram Cancer
Center
BAY80-6946 PI3 All Paclitaxel Bayer
AZD8186 PI3 TripleNegative AstraZeneca
Suspended as of 8/1 Triciribine Akt HER2- Cahaba
Trametinib, GSK2141795 Akt TripleNegative National Cancer Institute
BYL719 PI3 Hormone+_HER2- Letrozole Vanderbilt-Ingram Cancer
Center
BYL719, AMG479 PI3K, IGF1, and Hormone+ Novartis, Amgen
IGF2
BYL719, BGJ398 PI3 All Novartis
BYL719 PI3 Hormone+ Letrozole or exemes- Sloan Kettering
tane
BYL719 PI3 N/A Paclitaxel Novartis
LDE225, BKM120 PI3K, Hedge- All Novartis
hog
LY3023414 PI3/mTOR All Eli Lilly
PF-05212384 PI3/mTOR All Docetaxel (ER+), cis- Pfizer
platin (triple negative),
dacomitinib (HER2+)
AZD2014 mTOR Hormone+ Fulvestrant AstraZeneca
MGAH22 mTOR HER2- MacroGenics
Everolimus mTOR HER2+ Lapatinib University of Kansas
Everolimus mTOR Hormone+_HER2- Letrozole Novartis
Everolimus mTOR Hormone+_HER2- Trastuzumab Emory University
Everolimus mTOR Hormone+_HER2- Fulvestrant Eastern Cooperative Oncology
Group (ECOG)
Everolimus/exemestane mTOR Hormone+ Compared to Novartis
everolimus alone or
capecitabine
Everolimus/fulvestrant mTOR Hormone+ Compared to fulves- SWOG collaboration with
or everolimus/fulves- trant alone Novartis and AstraZeneca
trant/anastrozole
Everolimus/letrozole/ mTOR Hormone+_HER2- University of Maryland
lapatinib
CC-223 mTOR All Celgene
Unknown as of 8/1 Sirolimus (rapamycin) mTOR HER2+ Hercpetin Yale Cancer Center