DRUG
Pasireotide LAR
20 and 40 mg of powder in vials and 2 mL of vehicle in ampoules (for reconstitution) administered as a depot intragluteal IM (intramuscular) injection
Evaluate the Efficacy and Safety of Pasireotide LAR (Long Acting Release) on the Treatment of Patients With Clinically Non-Functioning Pituitary Adenoma.
Status
Completed
Phase
Phase 2
Enrollment
20
Locations
7
Results
Posted
Publications
0
Study summary
What the protocol is testing.
This study assessed pasireotide LAR efficacy on patients with non-functioning pituitary adenomas concerning tumor growth.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Jan 26, 2011
Study start
Nov 26, 2012
Primary completion
Sep 12, 2017
Study completion
Sep 12, 2017
Results posted
Apr 26, 2019
Registry updated
Apr 26, 2019
Outcomes
What the study measures.
Primary outcomes
Percentage of Participants With Non-functioning Pituitary Adenomas (NFPA) Who Achieve Tumor Volume Reduction of at Least 20% After 24 Weeks (FAS)
Time frame · Baseline up to 24 weeks
Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility.The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor. A change ≥ 20% in the original volume of the tumor was considered to be clinically significant. Evaluable participants required tumor volume assessment at baseline and at week 24.
Secondary outcomes
Tumor Volume Main Phase (FAS)
Time frame · baseline to week 4, 12, 24
Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.
Tumor Volume in Extension Phase (FAS)
Time frame · baseline to week 48, 72, 96
Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.
Tumor Volume Change From Baseline in Main Phase (FAS)
Time frame · baseline to week 4, 12, 24
Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.
Tumor Volume Change From Baseline in Extension Phase (FAS)
Time frame · baseline to week 48, 72, 96
Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.
Tumor Volume Percent Change From Baseline in Main Phase (FAS)
Time frame · baseline to week 4, 12, 24
Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.
Tumor Volume Percent Change From Baseline in Extension Phase (FAS)
Time frame · baseline to week 48, 72, 96
Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.
Percentage of Patients Achieving Tumour Volume Reduction in Main Phase (FAS)
Time frame · baseline to week 4, 12, 24
Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.
Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Main Phase (FAS)
Time frame · baseline to week 4, 12, 24
Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.
Percentage of Patients Achieving Tumour Volume Reduction in Extension Phase (FAS)
Time frame · baseline to week 48, 72, 96
Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.
Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Extension Phase (FAS)
Time frame · baseline to week 48, 72, 96
Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Non-functioning pituitary adenoma ≥ 1cm, patients without any previous treatment for the tumor * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Exclusion Criteria: * Patients who required a surgical intervention for relief of any sign or symptom associated with tumor compression * Previous pituitary surgery * Previous medical treatment for pituitary tumor * Patients who had received pituitary irradiation within 10 years prior to randomization * Prolactin (PRL) levels \> 100 ng/mL. PRL evaluation should have been performed with diluted samples to ensure "hook effect." was avoided * Patients who presented prolactinomas, acromegaly or Cushing's disease * Patients with compression of the optic chiasm causing acute clinically significant visual field defects
Study locations
7 registered sites.
Brazil. Showing up to 24 locations stored in the fast local snapshot.
Novartis Investigative Site
Fortaleza, Ceará, Brazil
Novartis Investigative Site
Curitiba, Paraná, 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
São Paulo, São Paulo, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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