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

Non-functioning Pituitary Adenoma Clinical Trial

— Passion I  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01283542
• Other study ID #: CSOM230D2401
• Status: Completed
• Phase: Phase 2
• Start date: November 26, 2012
• Est. completion date: September 12, 2017

Study information

• Verified date: April 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 12, 2017
• Est. primary completion date: September 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Non-functioning Pituitary Adenoma
• Pituitary Diseases
• Pituitary Neoplasms

Intervention

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

Locations

Country	Name	City	State
Brazil	Novartis Investigative Site	Botucatu	SP
Brazil	Novartis Investigative Site	Curitiba	PR
Brazil	Novartis Investigative Site	Fortaleza	CE
Brazil	Novartis Investigative Site	Joinville	SC
Brazil	Novartis Investigative Site	Rio de Janeiro	RJ
Brazil	Novartis Investigative Site	Sao Paulo	SP
Brazil	Novartis Investigative Site	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline up to 24 weeks
Secondary	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.	baseline to week 4, 12, 24
Secondary	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.	baseline to week 48, 72, 96
Secondary	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.	baseline to week 4, 12, 24
Secondary	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.	baseline to week 48, 72, 96
Secondary	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.	baseline to week 4, 12, 24
Secondary	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.	baseline to week 48, 72, 96
Secondary	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.	baseline to week 4, 12, 24
Secondary	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.	baseline to week 4, 12, 24
Secondary	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.	baseline to week 48, 72, 96
Secondary	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.	baseline to week 48, 72, 96
Secondary	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	Baseline and at weeks 4, 12,24,48,72, 96
Secondary	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	Baseline and at weeks 24, 48, 96
Secondary	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	Baseline and at weeks 24, 48, 96
Secondary	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	Baseline and at weeks 24, 48, 96
Secondary	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	Baseline and at weeks 24, 48, 96
Secondary	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	Baseline and at weeks 24, 48, 96
Secondary	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	Baseline and at weeks 24, 48, 96
Secondary	Mean Alpha Subunit Levels in Main and Extension Phases (FAS)		Baseline and at weeks 12,24,48,72, 96
Secondary	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.	Baseline up to approximately Week 96