Table 1.
Clinical trials evaluating PI3K or mTOR inhibitor in patients with 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| Everolimus (RAD001) | NCT01332279 | Erlotinib | Radiation | Recurrent HNC, previously treated with radiation | I | Withdrawn (sponsor withdrawal) |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 |