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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 July 2017 by Novartis ( Novartis Pharmaceuticals )
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01283542
First received: December 17, 2010
Last updated: July 19, 2017
Last verified: July 2017
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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: No masking 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:
Pituitary Disorders
Drug Information available for:
Pasireotide
U.S. FDA Resources
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| 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
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
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 | 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 |
| Study First Received: | December 17, 2010 |
| Last Updated: | July 19, 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 |
ClinicalTrials.gov processed this record on July 21, 2017