Evaluate the Efficacy and Safety of Pasireotide LAR (Long Acting Release) on the Treatment of Patients With Clinically Non-Functioning Pituitary Adenoma.

Phase 2

Completed

Conditions: Non-functioning Pituitary Adenoma

Interventions: Drug: Pasireotide LAR

Registration Number: NCT01283542

Lead Sponsor: Novartis Pharmaceuticals

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pasireotide LAR	Pasireotide LAR	All patients will receive pasireotide LAR (long acting release) 60 mg every 28 ± 3 days for 24 weeks

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Non-functioning Pituitary Adenomas (NFPA) Who Achieve Tumor Volume Reduction of at Least 20% After 24 Weeks (FAS)	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 Outcome Measures

Name	Time	Method
Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Main Phase (FAS)	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.
Mean GH and IGF-1 Hormone Levels During Main and Extension Phases (FAS)	Baseline and at weeks 24, 48, 96	Hormone levels, including those of GH, IGF-1, and prolactin were evaluated by a central lab
Percentage of Patients Achieving Tumour Volume Reduction in Main Phase (FAS)	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 Extension Phase (FAS)	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 Participants With Reduction From Baseline of Alpha Subunit ≥50% in Main and Extension Phases (FAS)	Baseline up to approximately Week 96	Alpha subunit levels were determined at a central laboratory.
Mean Cortisol Hormone Levels During Main and Extension Phases (FAS)	Baseline and at weeks 24, 48, 96	Hormone levels, including those of GH, IGF-1, follicle-stimulating hormone (FSH), luteinizing hormone (LH), adrenocorticotropic hormone (ACTH), thyroid-stimulating hormone (TSH), prolactin, cortisol, free T4, and estradiol (for women) or testosterone (for men), were evaluated by a central lab
Mean LH and FSH Hormone Levels During Main and Extension Phases (FAS)	Baseline and at weeks 24, 48, 96	Hormone levels, including those of GH, IGF-1, follicle-stimulating hormone (FSH), luteinizing hormone (LH), adrenocorticotropic hormone (ACTH), thyroid-stimulating hormone (TSH), prolactin, cortisol, free T4, and estradiol (for women) or testosterone (for men), were evaluated by a central lab
Tumor Volume Change From Baseline in Main Phase (FAS)	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)	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 Extension Phase (FAS)	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 Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS)	Baseline and at weeks 4, 12,24,48,72, 96	The absence and presence of disease-related symptoms were reported by patients and recorded by the medical staff. Patients classified the symptoms according to a 5-point scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe
Mean TSH Hormone Levels During Main and Extension Phases (FAS)	Baseline and at weeks 24, 48, 96	Hormone levels, including those of GH, IGF-1, follicle-stimulating hormone (FSH), luteinizing hormone (LH), adrenocorticotropic hormone (ACTH), thyroid-stimulating hormone (TSH), prolactin, cortisol, free T4, and estradiol (for women) or testosterone (for men), were evaluated by a central lab
Mean Alpha Subunit Levels in Main and Extension Phases (FAS)	Baseline and at weeks 12,24,48,72, 96
Tumor Volume Main Phase (FAS)	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 Main Phase (FAS)	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)	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.
Mean Testosterone and Free T4 Hormone Levels During Main and Extension Phases (FAS)	Baseline and at weeks 24, 48, 96	Hormone levels, including those of GH, IGF-1, follicle-stimulating hormone (FSH), luteinizing hormone (LH), adrenocorticotropic hormone (ACTH), thyroid-stimulating hormone (TSH), prolactin, cortisol, free T4, and estradiol (for women) or testosterone (for men), were evaluated by a central lab
Tumor Volume in Extension Phase (FAS)	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.
Mean ACTH and Estradiol Hormone Levels During Main and Extension Phases (FAS)	Baseline and at weeks 24, 48, 96	Hormone levels, including those of growth hormone (GH),insulin-like growth factor 1 (IGF-1), follicle-stimulating hormone (FSH), luteinizing hormone (LH), adrenocorticotropic hormone (ACTH), thyroid-stimulating hormone (TSH), prolactin, cortisol, free thyroxine (free T4), and estradiol (for women) or testosterone (for men), were evaluated by a central lab