Dacomitinib (PF-00299804) in Advanced/Metastatic Squamous Cell Carcinoma of the Penis
Status:
Completed
Trial end date:
2018-09-21
Target enrollment:
Participant gender:
Summary
Penile squamous cell carcinoma (SCC) is a very rare disease and prognosis depends primarily
on regional lymph-node involvement. Despite the fact that cure can be obtained in patients
with low metastatic load (pN1) by monotherapy, combination therapy is required for more
advanced cases. Medical treatment options only for advanced or metastatic penile SCC are not
very effective so far and the few chances for cure are solely dependent on multimodality
treatment, either with surgery or radiation. Based on the observation that the epidermal
growth factor receptor (EGFR) is almost invariably expressed in penile SCC and assuming
similarities to the SCC of head and neck district, anti-EGFR targeted monotherapy has been
investigated with promising early results at Istituto Tumori Milan and University of Texas MD
Andreson Cancer Center. These premises lend support to the use of the pan-HER inhibitor
dacomitinib for advanced or metastatic penile SCC.
Phase:
Phase 2
Details
Lead Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano