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

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.

• Authors: Robert M Eager, C Casey Cunningham, Neil N Senzer, Joe Stephenson Jr, Stephen P Anthony, Steven J O'Day, Gary Frenette, Anna C Pavlick, Barry Jones, Margaret Uprichard, John Nemunaitis
• Journal: BMC cancer (BMC Cancer) Vol. 9 Pg. 263 (Jul 30 2009) ISSN: 1471-2407 [Electronic] England
• PMID: 19643020 (Publication Type: Clinical Trial, Phase II, Journal Article)

Chemical References

• Boronic Acids
• Dipeptides
• talabostat
• Cisplatin

Topics

• 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