This study assessed pasireotide LAR efficacy on patients with non-functioning pituitary adenomas concerning tumor growth.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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
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
Percentage of Participants With Non-functioning Pituitary Adenomas (NFPA) Who Achieve Tumor Volume Reduction of at Least 20% After 24 Weeks (FAS)
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.
Time frame: Baseline up to 24 weeks
Tumor Volume Main Phase (FAS)
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.
Time frame: baseline to week 4, 12, 24
Tumor Volume in Extension Phase (FAS)
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.
Time frame: baseline to week 48, 72, 96
Tumor Volume Change From Baseline in Main Phase (FAS)
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.
Time frame: baseline to week 4, 12, 24
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Novartis Investigative Site
Botucatu, São Paulo, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Tumor Volume Change From Baseline in Extension Phase (FAS)
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.
Time frame: baseline to week 48, 72, 96
Tumor Volume Percent Change From Baseline in Main Phase (FAS)
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.
Time frame: baseline to week 4, 12, 24
Tumor Volume Percent Change From Baseline in Extension Phase (FAS)
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.
Time frame: baseline to week 48, 72, 96
Percentage of Patients Achieving Tumour Volume Reduction in Main Phase (FAS)
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.
Time frame: baseline to week 4, 12, 24
Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Main Phase (FAS)
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.
Time frame: baseline to week 4, 12, 24
Percentage of Patients Achieving Tumour Volume Reduction in Extension Phase (FAS)
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.
Time frame: baseline to week 48, 72, 96
Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Extension Phase (FAS)
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.
Time frame: baseline to week 48, 72, 96
Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS)
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
Time frame: Baseline and at weeks 4, 12,24,48,72, 96
Mean GH and IGF-1 Hormone Levels During Main and Extension Phases (FAS)
Hormone levels, including those of GH, IGF-1, and prolactin were evaluated by a central lab
Time frame: Baseline and at weeks 24, 48, 96
Mean ACTH and Estradiol Hormone Levels During Main and Extension Phases (FAS)
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
Time frame: Baseline and at weeks 24, 48, 96
Mean Cortisol Hormone Levels During Main and Extension Phases (FAS)
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
Time frame: Baseline and at weeks 24, 48, 96
Mean LH and FSH Hormone Levels During Main and Extension Phases (FAS)
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
Time frame: Baseline and at weeks 24, 48, 96
Mean Testosterone and Free T4 Hormone Levels During Main and Extension Phases (FAS)
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
Time frame: Baseline and at weeks 24, 48, 96
Mean TSH Hormone Levels During Main and Extension Phases (FAS)
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
Time frame: Baseline and at weeks 24, 48, 96
Mean Alpha Subunit Levels in Main and Extension Phases (FAS)
Time frame: Baseline and at weeks 12,24,48,72, 96
Percentage of Participants With Reduction From Baseline of Alpha Subunit ≥50% in Main and Extension Phases (FAS)
Alpha subunit levels were determined at a central laboratory.
Time frame: Baseline up to approximately Week 96