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

This study is currently recruiting participants. (see Contacts and Locations)

Verified December 2014 by Novartis

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT01283542

First received: December 17, 2010

Last updated: December 1, 2014

Last verified: December 2014

History of Changes

Purpose

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

Condition	Intervention	Phase
Non-functioning Pituitary Adenoma	Drug: Pasireotide LAR	Phase 2


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: familial isolated pituitary adenoma

MedlinePlus related topics: Cancer

Drug Information available for: Pasireotide

U.S. FDA Resources

Further study details as provided by Novartis:

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 ] [ Designated as safety issue: Yes ]
Mean change of tumour volume assessed by pituitary MRI [ Time Frame: from baseline to week 4, 12 and 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

change in tumor volume [ Time Frame: 4, 12 and 24 weeks ] [ Designated as safety issue: Yes ]
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. ] [ Designated as safety issue: No ]
Percent change of tumour volume assessed by pituitary MRI [ Time Frame: from baseline to week 4, 12 and 24 ] [ Designated as safety issue: No ]
Proportion of patients achieving tumour volume reduction of at least ≥ 20% [ Time Frame: after 4, 12 and 24 weeks ] [ Designated as safety issue: No ]


Estimated Enrollment:	23
Study Start Date:	November 2012
Estimated Study Completion Date:	December 2016
Estimated Primary Completion Date:	December 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Pasireotide LAR	Drug: Pasireotide LAR

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01283542

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	Withdrawn
Brasilia, DF, Brazil, 70840-901
Novartis Investigative Site	Recruiting
Sao Luis, MA, Brazil, 65020-070
Novartis Investigative Site	Recruiting
Curitiba, PR, Brazil, 80030-110
Novartis Investigative Site	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	Withdrawn
São Paulo, SP, Brazil, 01401-901
Novartis Investigative Site	Recruiting
São Paulo, SP, Brazil, 04023-900

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators


Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information

No publications provided


Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01283542 History of Changes
Other Study ID Numbers:	CSOM230D2401
Study First Received:	December 17, 2010
Last Updated:	December 1, 2014
Health Authority:	Brazil: ANVISA (Angência Nacional Vigilãncia Sanitária)

Keywords provided by Novartis:


Non-functioning pituitary adenoma, pasireotide LAR, tumor volume

Additional relevant MeSH terms:


Pituitary Neoplasms Adenoma Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Hypothalamic Diseases	Hypothalamic Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Nervous System Diseases Nervous System Neoplasms Pituitary Diseases Supratentorial Neoplasms

ClinicalTrials.gov processed this record on March 03, 2015

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