October 22, 2012
Lexicon Pharmaceuticals reported results from a phase II trial of telotristat etiprate in carcinoid syndrome. This open-label, dose-escalation study enrolled 15 patients with metastatic carcinoid syndrome who were refractory to or could not tolerate somatostatin analog therapy. Subjects received ascending doses of telotristat etiprate 150mg, 250mg, 350mg and 500mg, administered three times daily for 14 days on each dose until reaching a maximal dose, which was then continued until the completion of 12 weeks of therapy. Data showed subjects experienced a 46.4% median reduction from baseline at week 12, with the number of daily bowel movements steadily decreasing over time. All observed changes from baseline were statistically significant at p<0.001. At the completion of 12 weeks, 75% of subjects reported improvement. Subjects also saw statistically significant improvements in stool consistency (p<0.001), trends of reductions in abdominal pain (p=0.09) and the number of cutaneous flushing episodes (p=0.052). The median percentage reductions from baseline of urinary 5-HIAA at weeks 8 and 12 were 68.3% (p=0.019) and 72.7% (p=0.031), respectively. Telotristat etiprate was well tolerated. There was no evidence of dose-limiting toxicity. Based on these data, Lexicon is advancing telotristat etiprate to phase III trials.
July 12, 2010
Novartis issued positive results from a phase III trial of everolimus for the treatment of pancreatic neuroendocrine tumors. This U.S-based, double-blind, randomized, parallel group, placebo-controlled trial, RADIANT-3 (RAD001 In Advanced Neuroendocrine Tumors), enrolled 410 subjects. The subjects received everolimus (10 mg/day) plus best supportive care or placebo plus best supportive care. The primary endpoint, progression free survival, was reached. Everolimus extended median progression-free survival from 4.6 to 11.0 months versus placebo and reduced risk of cancer progression by 65% (p<0.0001). There were no unexpected adverse events.
June 7, 2010
Novartis issued positive preliminary results from a phase III trial of everolimus for the treatment of pancreatic neuroendocrine tumors. This U.S-based, double-blind, randomized, parallel group, placebo-controlled, dubbed RADIANT-3 (RAD001 In Advanced Neuroendocrine Tumors) enrolled 410 subjects with advanced pancreatic neuroendocrine tumors. The subjects received everolimus (10 mg/day) pplus best supportive care or placebo plus best supportive care. The primary endpoint, progression free survival, was reached. The addition of everolimus to best supportive care significantly extended progression-free survival compared to best supportive care alone.
April 19, 2010
Molecular Insight Pharmaceuticals reported positive results from a phase II trial of Onalta, a radiotherapeutic for the treatment of metastatic carcinoid tumors. This single arm study enrolled 90 subjects with malignant metastatic carcinoid tumors (neuroendocrine tumors of the gastrointestinal tract and bronchus) who were refractory to conventional treatment with octreotide. The subjects received three cycles of 4.4 gigabecquerels each, once every six weeks. Treatment with Onalta resulted in objective tumor response or stable disease in 67 (74.4%) subjects. Median progression-free survival and overall survival were 16.3 and 26.9 months, respectively. In addition, a trend toward improvement of symptoms, including severe diarrhea, hot flushes and abdominal pain, was consistently demonstrated and statistically significant across all symptoms. Onalta was well-tolerated and had an acceptable adverse event profile.