Effect of Pasireotide Long Acting Release (LAR) on Gonadotroph Adenomas

NCT00929669 | Terminated Phase 2 Results DMC

• 1 other identifier: 809652
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if administration of pasireotide LAR for one year to three patients with gonadotroph adenomas and elevated serum FSH concentrations will reduce the serum follicle-stimulating hormone (FSH) to normal and reduce the adenoma size.

Conditions

Gonadotroph Adenomas

Keywords

pituitary tumor; endocrine

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Change in Size of the Adenoma by ≥3 mm in at Least Two Dimensions as Determined by MRI

  MRI of the pituitary will be performed at baseline, Month 6 and Month 12 to demonstrate a decrease of ≥3 mm in at least two of three dimensions on MRI (cephalocaudal, transverse, and posterior-anterior). The outcome measure is defined as the number of participants who demonstrated a ≥3 mm decrease in adenoma size in two dimensions.

  12 months

Secondary Outcomes (1)

• Number of Participants With Change in Serum FSH Concentration (mIU/mL) in Patients Who Have Gonadotroph Adenomas Treated With Pasireotide.

  12 months

Study Arms (1)

Pasireotide LAR

EXPERIMENTAL

80 mg IM once monthly

Drug: pasireotide LAR

Interventions

pasireotide LAR DRUG

pasireotide LAR 80 mg IM once a month

Also known as: SOM230

Pasireotide LAR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• gonadotroph adenoma

You may not qualify if:

• visual impairment attributable to the adenoma
• radiation therapy
• active gallbladder disease
• uncontrolled diabetes

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Pituitary Neoplasms

Interventions

pasireotide

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Limitations and Caveats

This trial was terminated due to difficulty in identifying 3 subjects for completion of the study.

Results Point of Contact

• Title: Peter J. Snyder, MD
• Organization: University of Pennsylvania

pjs@mail.med.upenn.edu

215-898-0208

Study Officials

• Peter J. Snyder, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2009
• First Posted: June 29, 2009
• Study Start: June 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: November 28, 2017
• Results First Posted: November 28, 2017

Record last verified: 2017-10

Locations

US (1)