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Endocrine Abstracts (2014) 35 P885 | DOI: 10.1530/endoabs.35.P885

ECE2014 Poster Presentations Pituitary Clinical (<emphasis role="italic">Generously supported by IPSEN</emphasis>) (108 abstracts)

Study Design of a Phase II trial of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing's disease

Richard Feelders 1 , Rosario Pivonello 2 , Alberto Pedroncelli 3 , Heather Patino 4 , Moncy Ye 4 , Mounir Aout 3 & Maria Fleseriu 5


1Department of Internal Medicine, Endocrine Section, Erasmus Medical Center, Rotterdam, The Netherlands; 2Department of Molecular and Clinical Endocrinology and Oncology, Section of Endocrinology, Università Federico II di Napoli, Naples, Italy; 3Novartis Pharma AG, Basel, Switzerland; 4Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA; 5Departments of Medicine and Neurological Surgery, Northwest Pituitary Center, Oregon Health & Science University, Portland, Oregon, USA.


Background: Dopamine and somatostatin receptors on corticotroph pituitary adenomas are targets for medical treatment of Cushing’s disease (CD). Data indicate synergistic effects between pasireotide and cabergoline in improving biochemical control rates and clinical features in patients with CD.

Objective: To evaluate safety and efficacy of pasireotide alone or with cabergoline in patients with CD.

Methods: Patients: adults with confirmed diagnosis of CD (persistent/recurrent/de novo not considered candidates for pituitary surgery). Group 1: pasireotide-naïve patients or who had discontinued pasireotide earlier for lack of efficacy; Group 2: patients currently receiving MTD of pasireotide monotherapy for ≥8 weeks, but biochemically uncontrolled (mean UFC (mUFC)>ULN; mean of three samples with 2/3>ULN). Design: phase II, multicenter, prospective, international, open-label, non-comparative. Target enrollment=128 (Group 1=68; Group 2=60). Treatment (stepwise): Group 1: pasireotide s.c. 600 μg bid for 8 weeks; if uncontrolled, dose increased to 900 μg bid for 8 weeks; if uncontrolled, pasireotide s.c. 900 μg bid+cabergoline 0.5 mg qd for 8 weeks (if intolerant of pasireotide 900 μg bid, 600 μg bid allowed); if uncontrolled, cabergoline dose increased to 1 mg qd for 8 weeks. Group 2: pasireotide (300/600/900 μg bid) s.c.+cabergoline 0.5 mg qd for 8 weeks; if uncontrolled, cabergoline dose increased to 1 mg qd for 8 weeks. For both groups, dose modifications for cabergoline due to safety are allowed. Endpoints: primary: proportion of responders (mUFC≤1.0×ULN) in i) Group 1: with pasireotide alone or with cabergoline at wk35 ii) Group 2: with pasireotide+cabergoline at wk17. Secondary: actual and percentage change in mUFC from baseline to study end; proportion of patients attaining mUFC≤1.0×ULN, proportion of UFC responders or patients having ≥50% reduction from baseline in mUFC at each scheduled visit; shift from baseline in clinical signs. No formal hypothesis testing planned. Proportion of patients (95% CI) attaining primary endpoint will be reported.

Conclusions: This study will assess safety and efficacy of pasireotide in combination with cabergoline as a stepwise approach in the treatment of CD.

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