Clinical Trials Resource Center

Thyroid Disorders

November 14, 2011

NPS Pharmaceuticals reported results from a phase III trial of NPSP-558 for the treatment of hypoparathyroidism. This double-blind, placebo-controlled trial, REPLACE, enrolled 135 subjects. Following randomization, subjects underwent staged reductions in calcium and vitamin D supplementation, while maintaining stabilized serum calcium. If needed, step-wise up-titration of NPSP558 or placebo to a dose of 75 g and, if necessary, up to 100 g over a six to eight week period was performed. Subjects continued on their final dose through week 24. The primary efficacy was to demonstrate by week 24 at least a 50 percent reduction from baseline of oral calcium supplementation and active vitamin D metabolite/analog therapy and a total serum calcium concentration that was normalized or maintained compared to baseline. In an intent-to-treat analysis, 53% of NPSP558-treated subjects achieved the primary endpoint versus 2% of placebo-treated subjects (p<0.0001). At week 24, 43% of subjects treated with NPSP558 were able to achieve independence from active vitamin D therapy and a calcium supplementation dose of 500 mg/day or less, as compared to 5% of subjects treated with placebo (p<0.0001).

March 23, 2009

OxiGENE reported positive results from a phase II trial of fosbretabulin for the treatment of anaplastic thyroid cancer (ATC). This US-based monotherapy trial enrolled 26 subjects with advanced or metastatic ATC who had progressed or relapsed following initial therapy. Fosbretabulin was administered on days 1, 8 and 15 of each 28-day cycle in a 10-minute intravenous infusion of 45 mg/m2. A total of 77 cycles of therapy were administered with a median of two cycles per subject. Treatment was continued until disease progression. Seven subjects (27%) experienced stable disease for at least six weeks, with a median duration of 12.3 months. The median survival was 4.7 months, with 34% of subjects alive at six months and 23% of patients alive at 12 months. Event-free survival at three months was 23.1% and at six months was 7.7%. Three subjects were alive at the time of last follow-up at 12.1, 24.4 and 37.9 months. Fosbretabulin was well-tolerated.

Related Medical Areas

This information does not represent a Lupus Research Institute endorsement of any listed study. It is merely a notice that the study is available. If you are presently under the care of a physician for lupus or other conditions, you should not disrupt your current program without discussing it with your doctor(s). Do not contact the Lupus Research Institute for information on these studies. Only contact the listed numbers. The Lupus Research Institute does not have any jurisdiction over or further involvement with these studies, other than to make people aware that they are being conducted.