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
:
Recruiting
First Posted
: January 26, 2011
Last Update Posted
: September 12, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-functioning Pituitary Adenoma | Drug: Pasireotide LAR | Phase 2 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Pasireotide LAR | Drug: Pasireotide LAR |
- 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 ]
- 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 ]

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

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
Contact: Novartis Pharmaceuticals | +41613241111 | ||
Contact: Novartis Pharmaceuticals |
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 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
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: | 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 |