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

BMC Cancer. 2009 Jul 30;9:263. doi: 10.1186/1471-2407-9-263.

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.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Boronic Acids / administration & dosage*
  • Cisplatin / administration & dosage*
  • Dipeptides / administration & dosage*
  • Disease Progression
  • Disease-Free Survival
  • Female
  • Humans
  • Male
  • Melanoma / drug therapy*
  • Middle Aged
  • Prognosis
  • Skin Neoplasms / drug therapy*
  • Treatment Outcome

Substances

  • Boronic Acids
  • Dipeptides
  • talabostat
  • Cisplatin