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


CONCLUSIONS
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.
Eager
Robert M
RM
Mary Crowley Cancer Research Centers, Dallas, TX, USA. eager.rm@gmail.com
Cunningham
C Casey
CC
Senzer
Neil N
NN
Stephenson
Joe
J
Anthony
Stephen P
SP
O'Day
Steven J
SJ
Frenette
Gary
G
Pavlick
Anna C
AC
Jones
Barry
B
Uprichard
Margaret
M
Nemunaitis
John
J
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001897:Boronic Acids / Q000008:administration & dosage*; D002945:Cisplatin / Q000008:administration & dosage*; D004151:Dipeptides / Q000008:administration & dosage*; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008297:Male; D008545:Melanoma / Q000188:drug therapy*; D008875:Middle Aged; D011379:Prognosis; D012878:Skin Neoplasms / Q000188:drug therapy*; D016896:Treatment Outcome
D001897:Boronic Acids; D004151:Dipeptides; C514044:talabostat; D002945:Cisplatin