Phase II assessment of talabostat and cisplatin in second-line stage IV melanoma

Autor: Anthony Stephen P, Stephenson Joe, Senzer Neil N, Cunningham C Casey, Eager Robert M, O'Day Steven J, Frenette Gary, Pavlick Anna C, Jones Barry, Uprichard Margaret, Nemunaitis John
Jazyk: angličtina
Rok vydání: 2009
Předmět:
Zdroj: BMC Cancer, Vol 9, Iss 1, p 263 (2009)
Druh dokumentu: article
ISSN: 1471-2407
DOI: 10.1186/1471-2407-9-263
Popis: Abstract Background Metastatic melanoma is an incurable disease with an average survival of less than one year. Talabostat is a novel dipeptidyl peptidase inhibitor with immunostimulatory properties. Methods This phase II, open label, single arm study was conducted to evaluate the safety and efficacy of 75–100 mg/m2 cisplatin combined with 300–400 mcg talabostat bid for 6, 21-day cycles. The primary endpoint was overall response. The rate of complete responses, duration of overall objective response, progression-free survival (PFS), and overall survival were the secondary endpoints. Results Six objective partial responses were recorded in the 74 patients (8.1%) in the intention-to-treat population. Five of these responses involved the 40 evaluable patients (12.5%). Thirty-one percent of patients reported SAEs to the combination of talabostat and cisplatin. Conclusion Acceptable tolerability was observed in the intention-to-treat population and antitumor activity was observed in 12.5% of evaluable patients, which is not greater than historical expectation with cisplatin alone.
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