Clinical trial NCT01283542: Evaluate the Efficacy and Safety of Pasireotide LAR (Long Acting Release) on the Treatment of Patients With Clinically Non-Functioning Pituitary Adenoma.
Official title: An Open-Label, Single Arm, Phase II Study to Evaluate the Efficacy and Safety of Pasireotide LAR on the Treatment of Patients With Clinically Non-Functioning Pituitary Adenoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-functioning Pituitary Adenoma
Keywords: Non-functioning pituitary adenoma,
pasireotide LAR,
tumor volume
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-01-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study assessed pasireotide LAR efficacy on patients with non-functioning pituitary adenomas concerning tumor growth.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Non-functioning Pituitary Adenomas (NFPA) Who Achieve Tumor Volume Reduction of at Least 20% After 24 Weeks (FAS)
timeFrame: Baseline up to 24 weeks
Secondary outcomes:
measure: Tumor Volume Main Phase (FAS)
timeFrame: baseline to week 4, 12, 24
measure: Tumor Volume in Extension Phase (FAS)
timeFrame: baseline to week 48, 72, 96
measure: Tumor Volume Change From Baseline in Main Phase (FAS)
timeFrame: baseline to week 4, 12, 24
measure: Tumor Volume Change From Baseline in Extension Phase (FAS)
timeFrame: baseline to week 48, 72, 96
measure: Tumor Volume Percent Change From Baseline in Main Phase (FAS)
timeFrame: baseline to week 4, 12, 24
measure: Tumor Volume Percent Change From Baseline in Extension Phase (FAS)
timeFrame: baseline to week 48, 72, 96
measure: Percentage of Patients Achieving Tumour Volume Reduction in Main Phase (FAS)
timeFrame: baseline to week 4, 12, 24
measure: Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Main Phase (FAS)
timeFrame: baseline to week 4, 12, 24
measure: Percentage of Patients Achieving Tumour Volume Reduction in Extension Phase (FAS)
timeFrame: baseline to week 48, 72, 96
measure: Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Extension Phase (FAS)
timeFrame: baseline to week 48, 72, 96
measure: Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS)
timeFrame: Baseline and at weeks 4, 12,24,48,72, 96
measure: Mean GH and IGF-1 Hormone Levels During Main and Extension Phases (FAS)
timeFrame: Baseline and at weeks 24, 48, 96
measure: Mean ACTH and Estradiol Hormone Levels During Main and Extension Phases (FAS)
timeFrame: Baseline and at weeks 24, 48, 96
measure: Mean Cortisol Hormone Levels During Main and Extension Phases (FAS)
timeFrame: Baseline and at weeks 24, 48, 96
measure: Mean LH and FSH Hormone Levels During Main and Extension Phases (FAS)
timeFrame: Baseline and at weeks 24, 48, 96
measure: Mean Testosterone and Free T4 Hormone Levels During Main and Extension Phases (FAS)
timeFrame: Baseline and at weeks 24, 48, 96
measure: Mean TSH Hormone Levels During Main and Extension Phases (FAS)
timeFrame: Baseline and at weeks 24, 48, 96
measure: Mean Alpha Subunit Levels in Main and Extension Phases (FAS)
timeFrame: Baseline and at weeks 12,24,48,72, 96
measure: Percentage of Participants With Reduction From Baseline of Alpha Subunit ≥50% in Main and Extension Phases (FAS)
timeFrame: Baseline up to approximately Week 96
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Novartis Investigative Site
state: CE
city: Curitiba
country: Brazil
facility: Novartis Investigative Site
state: PR
city: Rio de Janeiro
country: Brazil
facility: Novartis Investigative Site
state: RJ
city: Joinville
country: Brazil
facility: Novartis Investigative Site
state: SC
city: Botucatu
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: