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

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ClinicalTrials.gov Identifier: NCT01283542

Recruitment Status : Completed

First Posted : January 26, 2011

Last Update Posted : May 16, 2018

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

Study Description

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


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	20 participants
Allocation:	Non-Randomized
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
Actual Primary Completion Date :	May 5, 2016
Actual Study Completion Date :	May 5, 2016

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Familial isolated pituitary adenoma

MedlinePlus related topics: Pituitary Disorders

Drug Information available for: Pasireotide

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 ]
Mean change of tumour volume assessed by pituitary MRI [ Time Frame: from baseline to week 4, 12 and 24 ]

Secondary Outcome Measures :

change in tumor volume [ Time Frame: 4, 12 and 24 weeks ]
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. ]
Percent change of tumour volume assessed by pituitary MRI [ Time Frame: from baseline to week 4, 12 and 24 ]
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, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01283542

Locations


Brazil
Novartis Investigative Site
Fortaleza, CE, Brazil, 04636-000
Novartis Investigative Site
Curitiba, PR, Brazil, 80030-110
Novartis Investigative Site
Rio de Janeiro, RJ, Brazil, 21941-913
Novartis Investigative Site
Joinville, SC, Brazil, 89201260
Novartis Investigative Site
Botucatu, SP, Brazil, 18618-970
Novartis Investigative Site
Sao Paulo, SP, Brazil, 05403 000
Novartis Investigative Site
São Paulo, SP, Brazil, 04023-900

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators


Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information


Responsible Party:	Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01283542 History of Changes
Other Study ID Numbers:	CSOM230D2401
First Posted:	January 26, 2011 Key Record Dates
Last Update Posted:	May 16, 2018
Last Verified:	May 2018
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:


Adenoma Pituitary Diseases Pituitary Neoplasms 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

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