Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly

Completed · Phase 3

Conditions studied: Acromegaly

In brief

This study will evaluate the efficacy and safety of pasireotide LAR 40 and 60 mg versus octreotide LAR or lanreotide ATG in patients with inadequately controlled acromegaly.

Key facts

Study ID

NCT01137682

Run by

Novartis Pharmaceuticals

People needed

198

Starts

2010-07-19

Expected to finish

2017-02-28

Last updated by the study team

2018-04-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with written informed consent prior to any study related activity
• Patients who had inadequately controlled acromegaly as defined by a mean GH concentration of a 5-point profile over a 2-hour period > 2.5 µg/L and sex- and age-adjusted IGF-1 > 1.3 x upper limit of normal (ULN)
• Patients who had been treated with maximum indicated doses of octreotide LAR or lanreotide ATG for at least 6 months prior to visit 1 (screening). The maximum indicated dose for octreotide LAR was 30mg and for lanreotide ATG iwas120 mg
• Patients who had a diagnosis of pituitary micro- or macro adenoma. Patients could have been previously submitted to surgery
• Patients who completed the 24-week treatment period in core according to the requirements of the core study protocol or corresponding amendments could enter extension

You may not qualify if…

• Patients who had received pasireotide (SOM 230) prior to enrolment
• Concomitant treatment with Growth Hormone Receptor (GHR)-antagonist or dopamine agonists unless concomitant treatment was discontinued 8 weeks prior to visit 1 (screening)(8 weeks wash out period). Such patients must have been treated with octreotide LAR 30 mg or lanreotide ATG 120 mg monotherapy continuously for a minimum of 6 months prior to starting combination therapy and they should have been inadequately controlled on monotherapy.
• Patients who had compression of the optic chiasm causing acute clinically significant visual field defects
• Patients who required a surgical intervention for relief of any sign or symptom associated with tumor compression
• Patients who had received pituitary irradiation within 10 years prior to visit 1 (screening).
• Patients who had undergone major surgery/surgical therapy for any cause within 4 weeks prior to visit 1 (screening).
• Patients who were hypothyroid and not adequately treated with a stable dose of thyroid hormone replacement therapy

Where it is running

• Oregon Health & Science University — Portland, Oregon, United States
• University of Texas Southwestern Medical Center Division of Hematology/Oncolog — Dallas, Texas, United States
• Swedish Neuroscience Institute 550 17th Avenue, Suite 500 — Seattle, Washington, United States
• Novartis Investigative Site — CABA, Buenos Aires, Argentina
• Novartis Investigative Site — Edegem, Antwerpen, Belgium
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Ghent, Belgium
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Fortaleza, Ceará, Brazil
• Novartis Investigative Site — São Luís, Maranhão, Brazil
• Novartis Investigative Site — Rio de Janeiro, Rio de Janeiro, Brazil
• Novartis Investigative Site — Joinville, Santa Catarina, Brazil
• Novartis Investigative Site — Botucatu, São Paulo, Brazil
• Novartis Investigative Site — Campinas, São Paulo, Brazil
• Novartis Investigative Site — São Paulo, São Paulo, Brazil
• Novartis Investigative Site — São Paulo, São Paulo, Brazil
• Novartis Investigative Site — Sherbrooke, Quebec, Canada
• Novartis Investigative Site — Bogota, Cundinamarca, Colombia
• Novartis Investigative Site — Bogotá, Colombia
• Novartis Investigative Site — Cali, Colombia
• Novartis Investigative Site — Toulouse, Cedex 9, France
• Novartis Investigative Site — Bron, Cedex, France
• Novartis Investigative Site — Dijon, France
• Novartis Investigative Site — Le Kremlin-Bicêtre, France
• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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