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

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Withdrawn (sponsor withdrawal)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