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. Author manuscript; available in PMC: 2013 Oct 22.
Published in final edited form as: Oral Oncol. 2013 Feb 4;49(5):461–467. doi: 10.1016/j.oraloncology.2012.12.016

Table 4.

Clinical trials testing mTOR inhibition in HNSCC.

Trial number Stage Phase Regimen Recruitment Results
NCT00858663 Locally advanced, definitive radiotherapy I Cisplatin, IMRT, everolimus Complete RP2D: Everolimus 5 mg daily, cisplatin 30 mg/m2 weekly. DLT mucositis
NCT01333085 Locally advanced, induction I/II Carboplatin, paclitaxel, everolimus Ongoing NRa
NCT01133678 Locally advanced, induction I/II Cisplatin, paclitaxel, cetuximab, everolimus Ongoing NR
NCT01111058 Locally advanced, adjuvant II Everolimus vs. placebo Not recruiting NR
NCT01172769 R/M II Temsirolimus Ongoing NR
NCT01051791 R/M II Everolimus Terminated Terminated after stage I, no objective responses
NCT00942734 R/M II Everolimus, erlotinib Ongoing NR
NCT01256385 R/M II Temsirolimus ± cetuximab Ongoing NR
NCT01009203 R/M II Temsirolimus, erlotinib Terminated Terminated early for toxicities
NCT01009346 R/M I Cisplatin, cetuximab, everolimus Terminated Terminated early for toxicities
NCT01015664 R/M I/II Cisplatin, cetuximab, temsirolimus Ongoing NR
NCT01283334 R/M I/II Carboplatin, cetuximab, everolimus Ongoing NR
NCT01016769 R/M I/II Carboplatin, paclitaxel, temsirolimus Complete RP2D: Carboplatin AUC 1.5, paclitaxel 80 mg/m2, temsirolimus 25 mg IV on D1, 8 of 21 day cycle
a

Not Reported.