Over 2000 Posts da89165 Posted May 27, 2008 Over 2000 Posts Report Share Posted May 27, 2008 I was looking at the adrenal clinic website at MD Anderson and found they are printing a Pituitary Program Newsletter. I looked all over and could not find a date on the Newsletter. Here's the link to the page with the newsletter. It was newsletter #1. MD Anderson Endo page New Clinical Trial The Pituitary Tumor Program at M. D. Anderson Cancer Center will soon be opening a new multi-center Phase III clinical trial sponsored by Novartis: "A randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing?s disease." Pasireotide is a novel somatostatin analogue that exhibits a high binding affinity for four of the five known human somatostatin receptors, whereas expression of somatostatin receptors 1, 3 and 5 has been demonstrated in ACTH-secreting pituitary tumors. Pasireotide inhibits the release of ACTH from the tumor and thereby controls hypercortisolemia. The effect on tumor volume remains to be determined. The outcome of the clinical trial may allow pasireotide to become available for medical treatment for patients with Cushing?s disease. Eligibility criteria include: ? Patients (18 years or older) with persistent or recurrent Cushing?s disease secondary to an ACTH-secreting pituitary tumor after surgical resection are eligible to participate. ? Patients with de novo Cushing?s disease may be included only if they are not considered surgical candidates. ? Patients must not have received radiation therapy to the pituitary within the last ten years or have a pituitary tumor compressing the optic chiasm. ? Patients who are currently treated with adrenal blocking medications are eligible after a brief wash-out period. ? Additional criteria for participation in the study apply. Study participants will need to self-administer pasireotide subcutaneously twice daily and participate in 18 study visits at MD Anderson over the course of 14 months. Participants will not be charged for any costs related to the study drug or visits. Patients will have the option to continue to receive therapy with pasireotide after study completion as long as they do not meet any of the criteria for discontinuation of the study or until pasireotide is commercially available or the pasireotide development program is discontinued. Please contact Mary Jean Klein, Manager, Clinical Protocol Administration, at 713-792-2840 for further information. Link to comment Share on other sites More sharing options...
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