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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Non-functioning Pituitary Adenoma	Drug: Pasireotide LAR	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	23 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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
Actual Study Start Date :	November 26, 2012
Estimated Primary Completion Date :	September 30, 2017
Estimated Study Completion Date :	September 30, 2017

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Pasireotide LAR	Drug: Pasireotide LAR

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Proportion of patients with non-functioning pituitary adenomas (NFPA) who achieve tumor volume reduction of at least 20% after 24-week treatment with pasireotide LAR [ Time Frame: 24 weeks ]
2. Mean change of tumour volume assessed by pituitary MRI [ Time Frame: from baseline to week 4, 12 and 24 ]

Secondary Outcome Measures :

1. change in tumor volume [ Time Frame: 4, 12 and 24 weeks ]
2. the effect of pasireotide LAR in hormonal response, and relevant disease-related symptoms [ Time Frame: at screening (it will be considered as baseline) and at Weeks 4, 12 and 24. ]
3. Percent change of tumour volume assessed by pituitary MRI [ Time Frame: from baseline to week 4, 12 and 24 ]
4. Proportion of patients achieving tumour volume reduction of at least ≥ 20% [ Time Frame: after 4, 12 and 24 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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 require 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 have received pituitary irradiation within 10 years prior to randomization
• Prolactin (PRL) levels > 100 ng/mL. PRL evaluation should be performed with diluted samples to make sure to avoid the "hook effect."
• Patients presenting prolactinomas, acromegaly or Cushing's disease
• Patients with compression of the optic chiasm causing acute clinically significant visual field defects

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Novartis Pharmaceuticals	+41613241111
Contact: Novartis Pharmaceuticals

Locations

Brazil
Novartis Investigative Site	Recruiting
Fortaleza, CE, Brazil, 04636-000
Novartis Investigative Site	Withdrawn
Fortaleza, CE, Brazil, 60020-181
Novartis Investigative Site	Recruiting
Sao Luis, MA, Brazil, 65020-070
Novartis Investigative Site	Recruiting
Curitiba, PR, Brazil, 80030-110
Novartis Investigative Site	Active, not recruiting
Rio de Janeiro, RJ, Brazil, 21941-913
Novartis Investigative Site	Recruiting
Joinville, SC, Brazil, 89201260
Novartis Investigative Site	Recruiting
Botucatu, SP, Brazil, 18618-970
Novartis Investigative Site	Recruiting
Campinas, SP, Brazil
Novartis Investigative Site	Recruiting
Sao Paulo, SP, Brazil, 05403-000
Novartis Investigative Site	Recruiting
São Paulo, SP, Brazil, 04023-900

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01283542 History of Changes
Other Study ID Numbers:	CSOM230D2401
First Posted:	January 26, 2011
Last Update Posted:	September 12, 2017
Last Verified:	September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

Non-functioning pituitary adenoma,; pasireotide LAR,; tumor volume

Additional relevant MeSH terms:

Pituitary Neoplasms; Adenoma; Pituitary Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases	Endocrine Gland Neoplasms; Neoplasms by Site; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Pasireotide; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs