Table 2. Ongoing Clinical Trials of Agents Targeting the PI3K Pathway in Patients with HNSCC.
| Target | Agent | Other Interventions | Condition | Phase | Status | Clinical Trial Identifier |
|---|---|---|---|---|---|---|
| PI3K | Buparlisib (BKM120) | Advanced HNSCC | 2 | Unknown | NCT01527877 | |
| Cisplatin, IMRT | High risk LA HNSCC | 1b | Active | NCT02113878 | ||
| Paclitaxel | Pt pre-treated R/M HNSCC | 2 | Active | NCT01852292 | ||
| Cetuximab | R/M HNSCC | 1/2 | Active | NCT01816984 | ||
| R/M HNC | 2 | Active | NCT01737450 | |||
| PX-866 | Docetaxel | NSCLC, HNSCC | 1/2 | Completed | NCT01204099 | |
| Cetuximab | Metastatic CRC, R/M HNSCC | 1/2 | Completed | NCT01252628 | ||
| Copanlisib (BAY 80-6946) | Cetuximab | R/M HNSCC with PI3KCA mutation/amplification and/or PTEN loss | 1/2 | Active | NCT02822482 | |
| SF1126 | R/M SCCHN with mutation in PIK3CA and/or PI3K Pathway | 2 | Active | NCT02644122 | ||
| Alpelisib (BYL-719) | Cisplatin, IMRT | LA HNSCC | 1 | Active | NCT02537223 | |
| Paclitaxel | Breast cancer and HNC | 1 | Active | NCT02051751 | ||
| Cetuximab, IMRT | Stage III/IVb HNSCC | 1 | Active | NCT02282371 | ||
| Pt therapy failed, R/M HNSCC | 2 | Active | NCT02145312 | |||
| Cetuximab | R/M HNSCC | 1b/2 | Completed | NCT01602315 | ||
| AMG319 | HPV negative HNSCC | 2 | Active | NCT02540928 | ||
| AKT | MK2206 | R/M HNC | 2 | Completed | NCT01349933 | |
| mTOR | Sirolimus (rapamycin) | HNSCC | 1/2 | Completed | NCT01195922 | |
| Everolimus (RAD001) | Docetaxel | LA and R/M HNSCC | 1/2 | Terminated | NCT01313390 | |
| Carboplatin, cetuximab | Advanced HNC | 1/2 | Completed | NCT01283334 | ||
| Carboplatin, paclitaxel | LA HNC not removable by surgery | 1/2 | Completed | NCT01333085 | ||
| Erlotinib | Recurrent HNSCC | 2 | Completed | NCT00942734 | ||
| Erlotinib, radiation | R/M HNSCC treated with radiation | 1 | Withdrawn | NCT01332279 | ||
| Cetuximab | R/M colon cancer or HNC | 1 | Completed | NCT01637194 | ||
| Cetuximab, cisplatin, carboplatin | R/M HNSCC | 1/2 | Terminated | NCT01009346 | ||
| HNSCC | 2 | Active | NCT01133678 | |||
| HNSCC | 2 | Active | NCT01051791 | |||
| HNC | 2 | Active | NCT01111058 | |||
| Docetaxel, cisplatin | LA HNC | 1 | Completed | NCT00935961 | ||
| Cisplatin, radiation | LA, inoperable HNC | 1 | Terminated | NCT01057277 | ||
| Cisplatin, IMRT | LA HNC | 1 | Terminated | NCT01058408 | ||
| Cisplatin, IMRT | LA HNC | 1 | Completed | NCT00858663 | ||
| Ceritinib | HNC, NSCLC | 1/1b | Active | NCT02321501 | ||
| LA HNSCC | 2 | Active | NCT01133678 | |||
| Temsirolimus (CCI-779) | HNSCC | 2 | Completed | NCT01172769 | ||
| Cetuximab | R/M HNC not respond to therapy | 2 | Completed | NCT01256385 | ||
| Paclitaxel, carboplatin | R/M HNSCC | 1/2 | Active | NCT01016769 | ||
| Cisplatin, cetuximab | R/M HNSCC | 1/2 | Terminated | NCT01015664 | ||
| Advanced HNSCC | Completed | NCT00195299 | ||||
| Erlotinib | Pt-refractory or-ineligible, advanced SCC | 2 | Terminated | NCT01009203 | ||
| Cetuximab, cisplatin, radiation | Advanced HNC | pilot | Withdrawn | NCT01326468 | ||
| Ridaforolimus (AP23573, MK-8669, deforolimus) | Advanced HNC, NSCLC, colon cancer | 1 | Terminated | NCT01212627 | ||
| Metformin (glucophage) | Paclitaxel | R/M HNSCC | 2 | Terminated | NCT01333852 | |
| Cisplatin, radiation | LA HNSCC | 1 | Active | NCT02325401 | ||
| HNSCC | 0 | Active | NCT02402348 | |||
| HNSCC | 0 | Active | NCT02083692 | |||
| PI3K/AKT | Perifosine (KRX-0401) | R/M HNC | 2 | Terminated | NCT00062387 | |
| PI3K/PLK | Rigosertib (ON-01910) | Cisplatin, radiation | HNSCC | 1 | Completed | NCT02107235 |
Unknown: Status not verified over 2 years. Abbreviations: IMRT: Intensity-modulated radiotherapy. HNC: Head and Neck Cancer. SCC: Squamous cell carcinoma. HNSCC: Head and neck squamous cell carcinoma. NSCLC: Non small cell lung cancer. HPV: Human Papillomavirus. R/M: recurrent and/or metastatic