Pasireotide LAR Therapy of Silent Corticotroph Pituitary Tumors

Phase 2

Terminated

• Conditions: Pituitary Tumor; ACTH-producing Pituitary Tumour
• Interventions: Drug: Pasireotide LAR

• Registration Number: NCT02749227
• Lead Sponsor: Columbia University

Brief Summary

This is a phase II, open-label, 12-month pilot study in 10 patients with silent corticotroph pituitary tumors testing the hypotheses that Pasireotide long-acting release (LAR) treatment of patients with silent corticotroph pituitary tumors and elevated plasma Proopiomelanocortin (POMC) levels will reduce plasma POMC levels and this will be associated with a reduction in pituitary tumor size. Pasireotide LAR 40 mg will be administered monthly. Baseline and monthly visits on therapy will monitor plasma levels of POMC, other pituitary function, safety labs, glucose tolerance, physical examination, and visual fields. Pituitary magnetic resonance imaging (MRI) will be done at baseline, 6 months and 12 months of therapy. The eligible patient population will consist of adult patients with known silent corticotroph pituitary tumors and elevated plasma levels of POMC.

Detailed Description

Clinically non-functioning pituitary adenomas (CNFAs), the subtype of pituitary adenomas that does not appear to secrete biologically active hormone nor to have a characteristic clinical phenotype, are the most common type of pituitary macroadenoma at diagnosis. There is currently no option for medical therapy of CNFA, in general, or specifically of silent corticotroph tumors. Silent corticotroph tumors can range from being completely asymptomatic to becoming large and causing significant hypothalamic/pituitary dysfunction and visual symptoms, and most data support that this type of tumor has a more aggressive phenotype. Current therapy consists primarily of surgical removal of the tumor and for recurrent or residual tumors, repeated surgery and/or radiotherapy. In very aggressive tumors, chemotherapy has been tried with some success. Therefore, a need exists for a medical therapeutic option for the treatment of this tumor type. This project assesses this clinical need.

Study Timeline

• Study First Submitted: 2016-04-20
• Study First Submitted QC: 2016-04-20
• Study First Posted: 2016-04-22
• Study Start: 2017-07-10
• Status Verified: 2020-03
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31
• Results First Submitted: 2021-03-31
• Results First Submitted QC: 2021-03-31
• Last Update Submitted: 2021-03-31
• Results First Posted: 2021-04-27
• Last Update Posted: 2021-04-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pasireotide LAR Therapy	Pasireotide LAR	Subjects will receive Pasireotide LAR monthly. Safety labs and Pituitary MRI will be performed.

Primary Outcome Measures

Name	Time	Method
Change in Plasma Proopiomelanocortin (POMC) Levels	Baseline, 12 months	This is to measure the effect of Pasireotide LAR (long-acting release) treatment.

Secondary Outcome Measures

Name	Time	Method
Change in Pituitary Tumor Volume	Baseline, 12 months	This is to measure the effect of Pasireotide LAR (long-acting release) treatment.

Trial Locations

Locations (1)

Neuroendocrine Unit and Pituitary Center, Columbia University; 🇺🇸 New York, New York, United States