Neoplasms

All Conditions

Nervous System Diseases

Gland and Hormone Related Diseases

Adenoma

Pituitary Diseases

Pituitary Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Hypothalamic Diseases

Brain Diseases

Central Nervous System Diseases

Endocrine System Diseases

Endocrine Gland Neoplasms

Hypothalamic Neoplasms

Supratentorial Neoplasms

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

All Drugs and Chemicals

Pasireotide

Hormones

Hormone Antagonists

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

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

Pasireotide LAR

Novartis Pharmaceuticals

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

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

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

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.

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.

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

Hormone levels, including those of GH, IGF-1, and prolactin were evaluated by a central lab

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

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

Alpha subunit levels were determined at a central laboratory.

Age, Continuous

Sex: Female, Male

White/Caucasian ancestry

Black/African ancestry

Asian ancestry

Other

Race/Ethnicity, Customized

Body mass index (BMI)

Baseline participants met eligibility requirements and received at least 1 dose of study medication

Study Director

Evaluable participants required tumor volume assessment at baseline and at week 24

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

Main Baseline

Main Week 4

Main Week 12

Main Week 24

number of participants with evaluable data varied across visits

Tumor Volume Main Phase (FAS)

Extension Week 48

Extension Week 72

Extension Week 96

Tumor Volume in Extension Phase (FAS)

Tumor Volume Change From Baseline in Main Phase (FAS)

Tumor Volume Change From Baseline in Extension Phase (FAS)

Tumor Volume Percent Change From Baseline in Main Phase (FAS)

Tumor Volume Percent Change From Baseline in Extension Phase (FAS)

Week 4

Week 12

Week 24

Percentage of Patients Achieving Tumour Volume Reduction in Main Phase (FAS)

Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Main Phase (FAS)

Percentage of Patients Achieving Tumour Volume Reduction in Extension Phase (FAS)

Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Extension Phase (FAS)

Headache Absent

Headache Mild

Headache Moderate

Headache Severe

Visual Disturbances Absent

Visual Disturbances Mild

Visual Disturbances Moderate

Visual Disturbances Severe

Fatigue Absent

Fatigue Mild

Fatigue Moderate

Fatigue Severe

Decreased libido Absent

Decreased libido Mild

Decreased libido Moderate

Decreased libido Severe

Decreased libido Very severe

Erectile dysfunction Yes

Erectile dysfunction No

Regular Menses Yes

Regular Menses No

Baseline

Week 48

Week 72

Week 96

number of participants varied across visits

Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS)

IGF-1

Prolactin

Mean GH and IGF-1 Hormone Levels During Main and Extension Phases (FAS)

ACTH

Estradiol

participants with evaluable data varied across visits

Mean ACTH and Estradiol Hormone Levels During Main and Extension Phases (FAS)

number participants with evaluable data varied across visits

Mean Cortisol Hormone Levels During Main and Extension Phases (FAS)

Mean LH and FSH Hormone Levels During Main and Extension Phases (FAS)

Testosterone

Free T4

Mean Testosterone and Free T4 Hormone Levels During Main and Extension Phases (FAS)

Mean TSH Hormone Levels During Main and Extension Phases (FAS)

Mean Alpha Subunit Levels in Main and Extension Phases (FAS)

Evaluable participants had to have 50% reduction

Percentage of Participants With Reduction From Baseline of Alpha Subunit ≥50% in Main and Extension Phases (FAS)

Main Phase

Extension Phase

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

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial