Pasireotide LAR Therapy of Silent Corticotroph Pituitary Tumors (PASSILCORT)
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|ClinicalTrials.gov Identifier: NCT02749227|
Recruitment Status : Recruiting
First Posted : April 22, 2016
Last Update Posted : April 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pituitary Tumor ACTH-producing Pituitary Tumour||Drug: Pasireotide LAR||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Pasireotide LAR Treatment of Silent Corticotrophin Pituitary Tumors and Effects on Plasma Levels of POMC|
|Actual Study Start Date :||July 10, 2017|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||May 2018|
U.S. FDA Resources
Experimental: Pasireotide LAR Therapy
Subjects will receive Pasireotide LAR monthly. Safety labs and Pituitary MRI will be performed.
Drug: Pasireotide LAR
Pasireotide LAR (SIGNIFOR® LAR) is a somatostatin analog indicated for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option. It is a long acting release injectable suspension for intramuscular use.
The starting dose is Pasireotide LAR 40 mg/month IM, this will be increased to 60 mg/month at 6 months if a fall in POMC levels and/or tumor shrinkage are not attained.
Other Name: Signifor LAR
- Change in plasma Proopiomelanocortin (POMC) levels [ Time Frame: Baseline, 12 months ]This is to measure the effect of Pasireotide LAR (long-acting release) treatment.
- Change in pituitary tumor volume [ Time Frame: Baseline, 12 months ]This is to measure the effect of Pasireotide LAR (long-acting release) treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02749227
|Contact: Pamela U. Freda, MDfirstname.lastname@example.org|
|Contact: Carlos M. Reyes-Vidal, MDemail@example.com|
|United States, New York|
|Neuroendocrine Unit and Pituitary Center, Columbia University||Recruiting|
|New York, New York, United States, 10032|
|Contact: Pamela U. Freda, MD 212-305-2254|
|Contact: Carlos M. Reyes-Vidal, MD 212-305-4921 firstname.lastname@example.org|
|Principal Investigator:||Pamela Freda, MD||Professor of Medicine at the Columbia University Medical Center, Dept of Medicine Endocrinology|