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|
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.
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): 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|