Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly
NCT ID: NCT01137682
Last Updated: 2018-04-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
198 participants
INTERVENTIONAL
2010-07-19
2017-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Pasireotide LAR 40 mg
Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
Pasireotide
* Double-blind pasireotide LAR 40 mg i.m. injection once every 28 ± 2 days for 24 weeks or
* Double-blind pasireotide LAR 60 mg i.m. injection once every 28 ± 2 days for 24 weeks
Pasireotide LAR 60 mg
Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
Pasireotide
* Double-blind pasireotide LAR 40 mg i.m. injection once every 28 ± 2 days for 24 weeks or
* Double-blind pasireotide LAR 60 mg i.m. injection once every 28 ± 2 days for 24 weeks
Control arm (octreotide or lanreotide)
If a patient is randomized to the open label arm the investigator will either:
* be instructed to contact a Novartis delegate to initiate shipment of either octreotide LAR 30 mg or lanreotide ATG 120 mg from a Novartis or designee depot to the site, or
* continue to dispense either octreotide LAR 30 mg or lanreotide ATG 120 mg available at the institution to the patient if permitted by local regulations.
octreotide LAR 30mg
In an open-label, active control arm, continue on the same treatment with octreotide LAR 30 mg every 28 ± 2 days as received for at least 6 months prior to randomization
lanreotide ATG 120mg
In an open-label, active control arm, continue on the same treatment with lanreotide ATG 120 mg every 28 ± 2 days as received for at least 6 months prior to randomization
Interventions
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Pasireotide
* Double-blind pasireotide LAR 40 mg i.m. injection once every 28 ± 2 days for 24 weeks or
* Double-blind pasireotide LAR 60 mg i.m. injection once every 28 ± 2 days for 24 weeks
octreotide LAR 30mg
In an open-label, active control arm, continue on the same treatment with octreotide LAR 30 mg every 28 ± 2 days as received for at least 6 months prior to randomization
lanreotide ATG 120mg
In an open-label, active control arm, continue on the same treatment with lanreotide ATG 120 mg every 28 ± 2 days as received for at least 6 months prior to randomization
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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)
3. 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
4. Patients who had a diagnosis of pituitary micro- or macro adenoma. Patients could have been previously submitted to surgery
5. 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
Exclusion Criteria
2. 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.
3. Patients who had compression of the optic chiasm causing acute clinically significant visual field defects
4. Patients who required a surgical intervention for relief of any sign or symptom associated with tumor compression
5. Patients who had received pituitary irradiation within 10 years prior to visit 1 (screening).
6. Patients who had undergone major surgery/surgical therapy for any cause within 4 weeks prior to visit 1 (screening).
7. Patients who were hypothyroid and not adequately treated with a stable dose of thyroid hormone replacement therapy
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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University of Michigan
Ann Arbor, Michigan, United States
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
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Edegem, Antwerpen, Belgium
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Brussels, , Belgium
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Ghent, , Belgium
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Leuven, , Belgium
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Fortaleza, Ceará, Brazil
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São Luís, Maranhão, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Joinville, Santa Catarina, Brazil
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Botucatu, São Paulo, Brazil
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Campinas, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Sherbrooke, Quebec, Canada
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Bogota, Cundinamarca, Colombia
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Bogotá, , Colombia
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Cali, , Colombia
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Toulouse, Cedex 9, France
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Bron, Cedex, France
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Dijon, , France
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Le Kremlin-Bicêtre, , France
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Lille, , France
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Marseille, , France
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Paris, , France
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Pessac, , France
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Rennes, , France
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Saint Herblain - Nantes, , France
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Erlangen, , Germany
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Hamburg, , Germany
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München, , Germany
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Würzburg, , Germany
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Petah Tikva, , Israel
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Genova, GE, Italy
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Messina, ME, Italy
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Roma, RM, Italy
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Torino, TO, Italy
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Napoli, , Italy
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Bergen, , Norway
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Oslo, , Norway
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Gdansk, , Poland
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Poznan, , Poland
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Wroclaw, , Poland
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Bucharest, , Romania
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Barnaul, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Tyumen, , Russia
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Jeddah, , Saudi Arabia
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Riyadh, , Saudi Arabia
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Seville, Andalusia, Spain
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Barcelona, Catalonia, Spain
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Alicante, Valencia, Spain
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Altunizade, , Turkey (Türkiye)
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Antalya, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
Novartis Investigative Site
Plymouth, , United Kingdom
Countries
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References
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Colao A, Bronstein MD, Brue T, De Marinis L, Fleseriu M, Guitelman M, Raverot G, Shimon I, Fleck J, Gupta P, Pedroncelli AM, Gadelha MR. Pasireotide for acromegaly: long-term outcomes from an extension to the Phase III PAOLA study. Eur J Endocrinol. 2020 Jun;182(6):583. doi: 10.1530/EJE-19-0762.
Gadelha MR, Bronstein MD, Brue T, Coculescu M, Fleseriu M, Guitelman M, Pronin V, Raverot G, Shimon I, Lievre KK, Fleck J, Aout M, Pedroncelli AM, Colao A; Pasireotide C2402 Study Group. Pasireotide versus continued treatment with octreotide or lanreotide in patients with inadequately controlled acromegaly (PAOLA): a randomised, phase 3 trial. Lancet Diabetes Endocrinol. 2014 Nov;2(11):875-84. doi: 10.1016/S2213-8587(14)70169-X. Epub 2014 Sep 24.
Other Identifiers
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EUDRACT 2009-016722-13
Identifier Type: REGISTRY
Identifier Source: secondary_id
CSOM230C2402
Identifier Type: -
Identifier Source: org_study_id
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