Table 3.
Ongoing Phase II and III clinical trials evaluating ErbB/HER family inhibitors as monotherapy in head and neck squamous cell carcinoma.
| Trial identifer | Estimated enrollment (n) |
Patient population | Therapy | Anticipated study completion |
Primary end point |
|---|---|---|---|---|---|
| NCT00661427 (Phase II) | 61 | Previously treated recurrent/metastatic HNSCC |
Cetuximab | May 2012 | RR |
|
NCT00446446 (PRISM; Phase II) |
52 | Previously treated recurrent/metastatic HNSCC |
Panitumumab | July 2011 | RR |
| NCT00542308 (Phase II) | 100 | Previously treated recurrent/metastatic HNSCC |
Zalutumumab/BSC | Completed† | OS |
| N C T 01415 674 (PREDICTOR; Phase II) |
60 | Untreated nonmetastatic HNSCC |
Afatinib | April 2013 | Biomarkers |
|
NCT01345669 (LUX-Head & Neck 2; Phase III) |
669 | Locoregionally advanced HNSCC treated with chemoradiotherapy |
Afatinib versus placebo |
April 2015 | DFS |
|
NCT01345682 (LUX-Head & Neck 1; Phase III) |
474 | Previously treated recurrent/metastatic HNSCC |
Afatinib versus methotrexate |
March 2014 | PFS |
| NCT01427478 (Phase III) | 315 | Untreated nonmetastatic HNSCC after postoperative radiochemotherapy |
Afatinib maintenance |
September 2016 | DFS |
| NCT01449201 (Phase II)‡ | 49 | Previously treated HNSCC | Dacomitinib | April 2013 | RR |
Includes trials indexed on [102] as of April 2012.
†
Results awaited.
‡
Study is not yet open for participant recruitment.
BSC: Best supportive care; DFS: Disease-free survival; HER: Human EGF receptor; HNSCC: Head and neck squamous cell carcinoma; OS: Overall survival; PFS: Progression-free survival; RR: Response rate