A phase II open-label trial of apomine (SR-45023A) in patients with refractory melanoma |
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Authors: | Karl D Lewis John A Thompson Jeffrey S Weber William A Robinson Steven O'Day Jose Lutzky Sewa S Legha Simon Floret Francis Ruvuna Rene Gonzalez |
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Institution: | (1) University of Colorado, Cancer Center, 1665 North Ursula St, Mail Stop F-703, Aurora, CO, 80045;(2) University of Washington, 825 Eastlake Ave E, Mail Stop G3-200, Seattle, WA, 98109;(3) University of Southern California, Norris Cancer Center, Room 3447 Topping, 1441 Eastlake Ave, Los Angeles, CA, 90033;(4) Cancer Institute Medical Group, 2001 Santa Monica Blvd Ste 1270W, Santa Monica, CA, 90404;(5) Mount Sinai Comprehensive Cancer Center, 4306 Alton Rd, Miami Beach, FL, 33140;(6) Saint Luke's Episcopal Hospital, 6624 Fannin St Ste 1440, Houston, TX, 77030;(7) ILEX Oncology Research Sarl—Geneva, 243 Route des Fayards, Versoix/Geneva, 1290, Switzerland;(8) ILEX Products, Inc., 4545 Horizon Hill Blvd, San Antonio, TX, 78248;(9) University of Colorado, Cancer Center, 1665 North Ursula St, Mail Stop F-703, Aurora, CO, 80045 |
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Abstract: | Summary Metastatic melanoma continues to be a very difficult disease to treat. Options are limited and often have very little impact
on the course of the disease. The objective of the current study was to evaluate the efficacy and safety of continuously administered
Apomine (SR-45023A), a novel bisphosphonate, in patients with previously treated metastatic malignant melanoma. Adult patients
with previously treated metastatic melanoma received Apomine 100 mg orally, twice daily (total dose 200 mg per day) continuously
for 28 days (defined as a cycle). Treatment was continued until disease progression or unacceptable toxicity. A total of 42
patients received at least one dose of Apomine. Stable disease was achieved in 2 patients (5%). No complete or partial responses
were observed. Progression free survival of at least 16 weeks was observed in 6 patients (14%). The median overall survival
was 6.1 months (95% CI, 4.9–9.4 months). Time to treatment failure was 1.7 months (95% CI, 1.6–1.8 months) with Apomine therapy.
By cycle 2, Apomine concentrations reached steady-state. Apomine was well tolerated with only 37% of patients experiencing
any drug-related event. Abdominal pain was the most frequent adverse event occurring in 26% of patients. In conclusion, Apomine,
at the current dose studied, failed to produce a 30% progression free survival rate at 16 weeks considered to be a meaningful
benefit for further development. |
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Keywords: | melanoma Apomine biphosphonate HMG CoA reductase |
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