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Table 1 Clinical trials evaluating PI3K or mTOR inhibitor in patients with HNSCC

From: Targeting phosphoinositide 3-kinase (PI3K) in head and neck squamous cell carcinoma (HNSCC)

Agent Clinical Trial Identifier Other Targeted Agent Additional Therapy Conditions Phase Status
PI3K inhibitor       
Alpelisib (BYL719) NCT02145312 R/M HNSCC, failed to respond to platinum-based therapy II Not yet recruiting
NCT02537223 Cisplatin, radiation Locoregionally advanced HNSCC, not previously treated I Active, recruiting
NCT01602315 Cetuximab R/M HNSCC I/II Terminated (sponsor withdrawal)
NCT02298595 Cetuximab Cisplatin HPV-associated oropharyngeal SCC I/II Not yet recruiting
Buparlisib (BKM120) NCT01816984 Cetuximab R/M HNC I/II Active, not recruiting
NCT01737450 Recurrent or progressive HNC II Active, recruiting
NCT02113878 Cisplatin, radiation Locally advanced HNSCC I Active, recruiting
PX-866 NCT01252628 Cetuximab   R/M HNSCC II Completed
NCT01204099 Docetaxel   Locally advanced or R/M HNSCC II Completed
Copanlisib NCT02822482 Cetuximab HNSCC with PI3KCA mutation/amplification or PTEN loss I/II Active, recruiting
INCB050465 NCT02646748 Itacitinib Pembrolizumab Advanced solid tumors I Active, recruiting
mTOR inhibitor       
Sirolimus NCT01195922 Advanced HNSCC, not previously treated I/II Completed
Temsirolimus NCT01172769 R/M HNSCC II Completed
NCT01009203 Erlotinib Advanced HNSCC, refractory to platinum II Terminated (high patient withdrawal rate)
NCT01016769 Paclitaxel, carboplatin R/M HNSCC I/II Active, not recruiting
NCT02215720 Cetuximab Advanced or metastatic solid tumors I Active, recruiting
NCT00703625 Docetaxel Resistant solid malignancies I Completed
Everolimus (RAD001) NCT01332279 Erlotinib Radiation Recurrent HNC, previously treated with radiation I Withdrawn (sponsor withdrawal)
NCT01313390 Docetaxel R/M HNSCC I/II Terminated (lack of recruitment)
NCT01009346 Cetuximab Cisplatin, carboplatin R/M HNSCC I/II Terminated (toxicity)
NCT01051791 R/M HNSCC II Active, not recruiting
PI3K/mTOR dual inhibitor       
SF1126 NCT02644122 R/M HNSCC II Active, recruiting
Gedatolisib NCT03065062 Palbociclib Advanced HNSCC I Active, recruiting
Dactolisib (BEZ235) NCT00620594 Advanced solid tumors I Completed
PI3K/HDAC dual inhibitor       
CUDC-907 NCT02307240 Advanced or relapsed solid tumors I Active, recruiting