Date: 2016-05-20
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Boehringer Ingelheim (Germany)
Product: afatinib
Action
mechanism: tyrosine kinase inhibitor. Afatinib is an irreversible ErbB Family Blocker which inhibits signal transduction of all kinase receptors from the ErbB Family, and is known to play a critical role in the growth and spread of the most pervasive cancers and cancers associated with high mortality (lung, breast, and head & neck cancers). Over-expression of the Epidermal Growth Factor Receptor (EGFR, also referred to as ErbB1) 1 is found in at least 90% of head and neck cancers and strongly correlates with poor prognosis and overall survival. Afatinib* is approved in over 70 countries for the first-line treatment of EGFR mutation-positive NSCLC. Approval of afatinib in this indication was based on the primary endpoint of PFS from the LUX-Lung 3 clinical trial where afatinib significantly delayed tumour growth when compared to standard chemotherapy. Afatinib is also approved in the EU, US and other markets for the treatment of patients with advanced squamous cell carcinoma (SqCC) of the lung whose disease has progressed on or after treatment with platinum-based chemotherapy. Approval of afatinib in this indication is based on results of the LUX-Lung 8 study, which showed a significantly improved overall survival and progression-free survival compared to erlotinib (Tarceva®) in patients with SqCC of the lung.
Disease: advanced/metastatic urothelial tract carcinoma
Therapeutic area: Cancer - Oncology
Country:
Trial
details: Primary objective is to investigate the efficacy in terms of 6 month progression free survival (PFS6) and objective response rate (ORR) of afatinib, in patients with advanced/metastatic urothelial tract carcinoma who have progressed despite prior platinum based chemotherapy. Other measures of efficacy include progression free survival (PFS), overall survival (OS), disease control rate (DCR), duration of objective response (DOR), and tumour shrinkage. (NCT02780687)
Latest
news: * On May 20, 2016, a Phase 2 trial sponsored by Boehringer Ingelheim was published on the NIH website ClinicalTrials.gov for afatinib and is currently recruiting participants.
