Phase II assessment of talabostat and cisplatin in second-line stage IV melanoma
1 Mary Crowley Cancer Research Centers, Dallas, TX, USA
2 Texas Oncology PA, Dallas, TX, USA
3 Baylor Sammons Cancer Center, Dallas, TX, USA
4 Gradalis, Inc., Dallas, TX, USA
5 Clinical Research Unit, Cancer Centers of the Carolinas, Greenville, SC, USA
6 Cancer Care Northwest, Spokane, WA, USA
7 The Angeles Clinic and Research Institute, Los Angeles, CA, USA
8 Carolinas Medical Center, Charlotte, NC, USA
9 Department of Dermatology, New York University Clinical Cancer Center, New York, NY, USA
10 Point Therapeutics, Inc., Boston, MA, USA
11 Department of Internal Medicine, The University of Hawaii, Honolulu, HI, USA
BMC Cancer 2009, 9:263 doi:10.1186/1471-2407-9-263Published: 30 July 2009
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.
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.
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.
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.