Trial Outcomes & Findings for Effect of Pasireotide Long Acting Release (LAR) on Gonadotroph Adenomas (NCT NCT00929669)

NCT ID: NCT00929669

Last Updated: 2017-11-28

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 2 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2017-11-28

Participant Flow

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.

Participant milestones

Measure	Pasireotide LAR 80 mg IM once monthly
Overall Study STARTED	2
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Pasireotide LAR 80 mg IM once monthly
Overall Study elevated glucose levels	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Pasireotide LAR n=2 Participants 80 mg IM once monthly
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants
patients with a gonadotroph adenoma	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Pasireotide LAR n=1 Participants 80 mg IM once monthly
Number of Participants With Change in Size of the Adenoma by ≥3 mm in at Least Two Dimensions as Determined by MRI	0 participants

SECONDARY outcome

Timeframe: 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%.

Outcome measures

Measure	Pasireotide LAR n=1 Participants 80 mg IM once monthly
Number of Participants With Change in Serum FSH Concentration (mIU/mL) in Patients Who Have Gonadotroph Adenomas Treated With Pasireotide.	0 number of participants

Adverse Events

Pasireotide LAR

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Pasireotide LAR n=2 participants at risk 80 mg IM once monthly
Endocrine disorders hyperglycemia	100.0% 2/2 • Number of events 2
Hepatobiliary disorders elevated liver enzymes	50.0% 1/2 • Number of events 1
Cardiac disorders sinus bradycardia	50.0% 1/2
Musculoskeletal and connective tissue disorders pain radiating down leg	50.0% 1/2
Eye disorders photophobia	50.0% 1/2

Additional Information

Peter J. Snyder, MD

University of Pennsylvania

Phone: 215-898-0208

Email: pjs@mail.med.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place