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

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00929669
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arm: 1
• Duration (Months): 29
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gonadotroph Adenomas	Drug: pasireotide LAR	Phase 2

Detailed Description

Gonadotroph adenomas are the most common pituitary macroadenomas. Currently no medical treatment as been found that decreases the size of these adenomas, so surgery is the only treatment. The reason to think that pasireotide might affect gonadotroph adenomas is that pasireotide binds avidly to somatostatin subtype 5 receptors, and gonadotroph adenomas express these receptors. For this study, three subjects who have gonadotroph adenomas, as judged by a macroadenoma of the pituitary and elevated serum FSH concentration, will be treated with a long-acting form of pasireotide once a month for one year. The effect of pasireotide on the size of the adenoma will be determined by MRI, and FSH secretion will be judged by the serum concentration.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Pasireotide LAR on Gonadotroph Adenomas: A Pilot Study
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pasireotide LAR 80 mg IM once monthly	Drug: pasireotide LAR; pasireotide LAR 80 mg IM once a month; Other Names: SOM230

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Change in Size of the Adenoma by ≥3 mm in at Least Two Dimensions as Determined by MRI [12 months]

   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.

Secondary Outcome Measures

1. Number of Participants With Change in Serum FSH Concentration (mIU/mL) in Patients Who Have Gonadotroph Adenomas Treated With Pasireotide. [12 months]

   Serum FSH (mIU/mL) will be measured at baseline and then monthly for the 12 months of the study to determine if serum FSH concentrations decrease by 20%.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• gonadotroph adenoma

Exclusion Criteria:

• visual impairment attributable to the adenoma

• radiation therapy

• active gallbladder disease

• uncontrolled diabetes

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania

Investigators

• Principal Investigator: Peter J. Snyder, MD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT00929669
• Other Study ID Numbers: 809652
• First Posted: Jun 29, 2009
• Last Update Posted: Nov 28, 2017
• Last Verified: Oct 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by University of Pennsylvania: pituitary tumor; endocrine
• Additional relevant MeSH terms: Adenoma; Pasireotide

Study Results

Participant Flow

Recruitment Details	This study was initiated in 6/09 and was terminated in 6/10. 2 subjects were enrolled and 1 subject completed the 12 mos. of the study.

Arm/Group Title	Pasireotide LAR
Arm/Group Description	80 mg IM once monthly
Period Title: Overall Study
STARTED	2
COMPLETED	1
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Pasireotide LAR
Arm/Group Description	80 mg IM once monthly
Overall Participants	2
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	1 50%
>=65 years	1 50%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	2 100%
Region of Enrollment (participants) [Number]
United States	2 100%
patients with a gonadotroph adenoma (participants) [Number]
Number [participants]	2 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Change in Size of the Adenoma by ≥3 mm in at Least Two Dimensions as Determined by MRI
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pasireotide LAR
Arm/Group Description	80 mg IM once monthly
Measure Participants	1
Number [participants]	0 0%

2. Secondary Outcome

Title	Number of Participants With Change in Serum FSH Concentration (mIU/mL) in Patients Who Have Gonadotroph Adenomas Treated With Pasireotide.
Description	Serum FSH (mIU/mL) will be measured at baseline and then monthly for the 12 months of the study to determine if serum FSH concentrations decrease by 20%.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pasireotide LAR
Arm/Group Description	80 mg IM once monthly
Measure Participants	1
Number [number of participants]	0 0%

Adverse Events

Arm/Group Title	Pasireotide LAR
Arm/Group Description	80 mg IM once monthly
All Cause Mortality
	Pasireotide LAR
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Pasireotide LAR
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Other (Not Including Serious) Adverse Events
	Pasireotide LAR
	Affected / at Risk (%)	# Events
Total	2/2 (100%)
Cardiac disorders
sinus bradycardia	1/2 (50%)
Endocrine disorders
hyperglycemia	2/2 (100%)	2
Eye disorders
photophobia	1/2 (50%)
Hepatobiliary disorders
elevated liver enzymes	1/2 (50%)	1
Musculoskeletal and connective tissue disorders
pain radiating down leg	1/2 (50%)

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.