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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.
Verified October 2012 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01283542
First received: December 17, 2010
Last updated: October 17, 2012
Last verified: October 2012
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:

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: 27
Study Start Date: April 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01283542

Contacts
Contact: Novartis Pharmaceuticals +1 800 340 6843

Locations
Brazil
Novartis Investigative Site Recruiting
Fortaleza, CE, Brazil
Novartis Investigative Site Withdrawn
Brasília, DF, Brazil
Novartis Investigative Site Recruiting
São Luís, MA, Brazil
Novartis Investigative Site Recruiting
Curitiba, PR, Brazil
Novartis Investigative Site Recruiting
Rio de Janeiro, RJ, Brazil
Novartis Investigative Site Recruiting
Joinville, SC, Brazil
Novartis Investigative Site Recruiting
Campinas, SP, Brazil
Novartis Investigative Site Withdrawn
São Paulo, SP, Brazil
Novartis Investigative Site Recruiting
São Paulo, SP, Brazil
Novartis Investigative Site Recruiting
Botucatu, Brazil
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: October 17, 2012
Health Authority: Brazil: ANVISA (Angência Nacional Vigilãncia Sanitária)

Keywords provided by Novartis:
Non-functioning pituitary adenoma,
pasireotide LAR,
tumor volume

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

ClinicalTrials.gov processed this record on May 19, 2013