Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly

Status:	Active, not recruiting
Conditions:	Skin Cancer, Endocrine
Therapuetic Areas:	Endocrinology, Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	February 2008
End Date:	March 2016

A Multicenter, Randomized, Blinded Study to Assess Safety and Efficacy of Pasireotide LAR vs. Octreotide LAR in Patients With Active Acromegaly

The patients will receive either Pasireotide LAR or Octreotide LAR for one year of
treatment.

The objective of this study is to compare the proportion of patients with a reduction of
mean GH level to <2.5 µg/L and the normalization of IGF-1 to within normal limits (age and
sex related) between the two treatment groups (pasireotide LAR and octreotide LAR) at 12
months.

Following one year of treatment patients may proceed into the study extension. Patients who
did not respond to the treatment they were randomized to (based on month 12 assessment
results) will be switched to the other treatment arm at month 13.

Inclusion criteria:

- Patients with active acromegaly (based on elevated GH and IGF-1 levels)

- Patients who have undergone one or more pituitary surgeries, but have not been
treated medically, or de-novo patients presenting a visible pituitary adenoma on MRI
and who refuse pituitary surgery or for whom pituitary surgery is contraindicated

- Patients for whom written informed consent to participate in the study has been
obtained prior to any study related activity

Exclusion criteria:

- Patients who are being or were treated with octreotide, lanreotide, dopamine agonists
or GH antagonists with the exception of a single dose of short-acting octrotide or
short-acting dopamine agonists. In case of a single dose of short-acting octrotide,
the dose should not be used to predict the response to the octretide treatment. The
single dose of short-acting octreotide or short-acting dopamine agonists should not
be administered in the 3 days prior to randomization

- Patients with compression of the optic chiasm causing any visual field defect

- Patients who have received pituitary irradiation within the last ten years prior to
visit 1

- Poorly controlled diabetic patients

Other protocol-defined inclusion/exclusion criteria may apply

We found this trial at

sites

University of Michigan Comprehensive Cancer Center Deptof Endocrinology&Diabetes

Ann Arbor, Michigan 48109

from

Ann Arbor, MI