Pasireotide in Patients With Acromegaly Inadequately Controlled With First Generation Somatostatin Analogues
A Phase IIIb Multicenter, Open-label, Single Arm Study to Evaluate the Efficacy and Safety of Pasireotide in Patients With Acromegaly Inadequately Controlled With First Generation Somatostatin Analogues
2 other identifiers
interventional
123
15 countries
50
Brief Summary
This is a phase IIIb multicenter, open-label; single arm study to evaluate the efficacy and safety of pasireotide LAR 40 mg and 60 mg in patients with inadequately controlled acromegaly with maximal approved doses of first generation somatostatin analogues. The study will enroll inadequately controlled patients by high doses (maximal approved) of first-generation somatostatin analogues given for at least 3 months. Patients will receive pasireotide LAR 40 mg or 60 mg during the 36 week core study phase. Patients who have completed all visits of core phase and have completed all the assessments at the core phase completion visit can move into the 32-week extension phase. Patients can continue with study treatment until pasireotide LAR is commercially available and reimbursed in their respective country or until the end of the extension phase whichever occurs first.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2015
Typical duration for phase_3
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2015
CompletedFirst Posted
Study publicly available on registry
February 3, 2015
CompletedStudy Start
First participant enrolled
March 31, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 8, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 27, 2018
CompletedResults Posted
Study results publicly available
December 4, 2019
CompletedDecember 10, 2019
December 1, 2019
2.8 years
January 29, 2015
September 26, 2019
December 6, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall
Percentage of participants who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at week 36.
Week 36
Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 for Participants Up-titrated to Pasireotide LAR 60 mg
Percentage of participants who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at week 36, for participants who had been up-titrated with pasireotide LAR 60 mg.
Week 36
Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36
Percentage of participants who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at week 36.
Wek 36
Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36
Percentage of patients who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at week 36, by previous treatment, type of therapy and overall.
Week 36
Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 Overall by Baseline Diabetic Status
Percentage of participants who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at week 36, overall by baseline diabetic status.
Week 36
Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall - LOCF
Percentage of participants who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at week 36, by previous treatment and overall - last observation carried forward (LOCF)
Week 36
Secondary Outcomes (18)
Core Phase: Change in Mean Growth Hormone (GH) Values From Baseline to Week 36
Baseline, week 36
Core Phase: Change in Standardized IGF-1 Values From Baseline to Week 36
Baseline, week 36
Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN
Week 12, Week 24, Week 36
Core Phase: Percentage of Participants With IGF-1 <ULN Overall by GH Level at Screening
Weeks 12, 24 & 36
Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN Overall by Baseline Diabetic Status
Weeks 12, 24 & 36
- +13 more secondary outcomes
Study Arms (1)
Pasireotide LAR
EXPERIMENTALPatients who qualify for the core phase of the study will be treated with pasireotide LAR 40 mg initially. Patients not achieving biochemical control can be up-titrated to pasireotide LAR 60 mg.
Interventions
Pasireotide 40 mg and 60 mg. Pasireotide 20 mg which was allowed for dose decrease in case of adverse event.
Eligibility Criteria
You may qualify if:
- Written informed consent
- Male and female patients ≥18 years
- Patients with confirmed diagnosis of inadequately controlled acromegaly (mean GH concentration ≥1 μg/L and sex- and age-adjusted IGF-1 \>1.3 x ULN)
- Patients treated with octreotide LAR (30 mg or 40 mg) or lanreotide ATG (120 mg) monotherapy for at least 3 months prior to screening
You may not qualify if:
- Concomitant treatment with other medications reducing GH and or IGF-1, unless discontinued 3 months prior to screening
- Patients with compression of the optic chiasm requiring surgical intervention
- Diabetic patients with HbA1c \>8% at screening
- Patients who are hypothyroid and not on adequate replacement therapy
- Patients with symptomatic cholelithiasis and acute or chronic pancreatitis
- Patients with clinically significant valvular disease
- Patients with risk factors for torsade de pointes (TdP)
- Hypokalaemia, hypomagnesaemia, uncontrolled hypothyroidism, family history of long QT syndrome or concomitant medications with known risk of TdP
- Patients with congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, clinically significant bradycardia, advanced heart block, history of acute MI less than one year prior to study entry or clinically significant impairment in cardiovascular function.
- Concomitant disease(s) that could prolong the QT interval such as autonomic neuropathy (caused by diabetes or Parkinson's disease), HIV, cirrhosis, uncontrolled hypothyroidism or cardiac failure
- Patients with liver disease or ALT/AST \> 2.0 X ULN, serum bilirubin \>2.0 X ULN - Presence of Hepatitis B surface antigen or Hepatitis C antibody test
- Patients with serum creatinine \>2.0 X ULN
- Patients with WBC \<3 X 109/L; Hb 90% \< LLN; PLT \<100 X 109/L
- Patients with active or suspected acute or chronic uncontrolled infection
- Patients who have undergone major surgery/surgical therapy within 4 weeks prior to screening
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
Novartis Investigative Site
CABA, Buenos Aires, C1180AAX, Argentina
Novartis Investigative Site
CABA, Buenos Aires, C1428AQK, Argentina
Novartis Investigative Site
Mar del Plata, Buenos Aires, B7602CBM, Argentina
Novartis Investigative Site
Brussels, 1200, Belgium
Novartis Investigative Site
Edegem, 2650, Belgium
Novartis Investigative Site
Leuven, 3000, Belgium
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, 21941-590, Brazil
Novartis Investigative Site
Sofia, 1431, Bulgaria
Novartis Investigative Site
Beijing, Beijing Municipality, 100730, China
Novartis Investigative Site
Guangzhou, Guangdong, 510080, China
Novartis Investigative Site
Chengdu, Sichuan, 610041, China
Novartis Investigative Site
Floridablanca, Santander Department, 57-7, Colombia
Novartis Investigative Site
Bogotá, Colombia
Novartis Investigative Site
Angers, 49933, France
Novartis Investigative Site
Besançon, 25030, France
Novartis Investigative Site
Bron, 69677, France
Novartis Investigative Site
Nîmes, 30029, France
Novartis Investigative Site
Reims, 51092, France
Novartis Investigative Site
Rouen, 76031, France
Novartis Investigative Site
Saint-Herblain, 44800, France
Novartis Investigative Site
Vandœuvre-lès-Nancy, 54511, France
Novartis Investigative Site
Szeged, HUN, 6720, Hungary
Novartis Investigative Site
Budapest, 1085, Hungary
Novartis Investigative Site
Ancona, AN, 60126, Italy
Novartis Investigative Site
Genova, GE, 16132, Italy
Novartis Investigative Site
Milan, MI, 20122, Italy
Novartis Investigative Site
Milan, MI, 20162, Italy
Novartis Investigative Site
Palermo, PA, 90127, Italy
Novartis Investigative Site
Padua, PD, 35128, Italy
Novartis Investigative Site
Pisa, PI, 56124, Italy
Novartis Investigative Site
Torino, TO, 10126, Italy
Novartis Investigative Site
Napoli, 80131, Italy
Novartis Investigative Site
Pulau Pinang, 10990, Malaysia
Novartis Investigative Site
Wilayah Persekutuan, 62502, Malaysia
Novartis Investigative Site
Guadalajara, Jalisco, 44130, Mexico
Novartis Investigative Site
Mexico City, Mexico City, 02990, Mexico
Novartis Investigative Site
Durango, 34270, Mexico
Novartis Investigative Site
Lisbon, 1349 019, Portugal
Novartis Investigative Site
Porto, 4099-001, Portugal
Novartis Investigative Site
Porto, 4200-319, Portugal
Novartis Investigative Site
Bucharest, 011863, Romania
Novartis Investigative Site
Iași, 700127, Romania
Novartis Investigative Site
Pendik / Istanbul, Turkey, 34899, Turkey (Türkiye)
Novartis Investigative Site
Istanbul, TUR, 34098, Turkey (Türkiye)
Novartis Investigative Site
Ankara, 06560, Turkey (Türkiye)
Novartis Investigative Site
Izmir, 35340, Turkey (Türkiye)
Novartis Investigative Site
Kocaeli, 41380, Turkey (Türkiye)
Novartis Investigative Site
London, EC1A 7BE, United Kingdom
Novartis Investigative Site
Nottingham, NG7 2UH, United Kingdom
Novartis Investigative Site
Plymouth, PL6 8DH, United Kingdom
Related Publications (1)
Gadelha M, Bex M, Colao A, Pedroza Garcia EM, Poiana C, Jimenez-Sanchez M, Yener S, Mukherjee R, Bartalotta A, Maamari R, Raverot G. Evaluation of the Efficacy and Safety of Switching to Pasireotide in Patients With Acromegaly Inadequately Controlled With First-Generation Somatostatin Analogs. Front Endocrinol (Lausanne). 2020 Feb 3;10:931. doi: 10.3389/fendo.2019.00931. eCollection 2019.
PMID: 32117045DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study is a single-arm study to evaluate the safety \& efficacy of pasireotide LAR in patients with inadequately controlled acromegaly who were previously on somatostatin analogues: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2015
First Posted
February 3, 2015
Study Start
March 31, 2015
Primary Completion
January 8, 2018
Study Completion
September 27, 2018
Last Updated
December 10, 2019
Results First Posted
December 4, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.