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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 September 2017 by Novartis ( Novartis Pharmaceuticals )
Sponsor:
ClinicalTrials.gov Identifier:
NCT01283542
First Posted: January 26, 2011
Last Update Posted: September 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  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: 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

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

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 ]

Estimated Enrollment: 23
Actual Study Start Date: November 26, 2012
Estimated Study Completion Date: September 30, 2017
Estimated Primary Completion Date: September 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pasireotide LAR Drug: Pasireotide LAR

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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


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

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01283542     History of Changes
Other Study ID Numbers: CSOM230D2401
First Submitted: December 17, 2010
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:
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


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