Trial Outcomes & Findings for Pasireotide LAR Therapy of Silent Corticotroph Pituitary Tumors (NCT NCT02749227)

NCT ID: NCT02749227

Last Updated: 2021-04-27

Results Overview

This is to measure the effect of Pasireotide LAR (long-acting release) treatment.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

Baseline, 12 months

Results posted on

2021-04-27

Participant Flow

Participant milestones

Participant milestones
Measure	Pasireotide LAR Therapy Subjects will receive Pasireotide LAR monthly. Safety labs and Pituitary MRI will be performed. 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 intramuscular (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.
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pasireotide LAR Therapy of Silent Corticotroph Pituitary Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pasireotide LAR Therapy n=4 Participants Subjects will receive Pasireotide LAR monthly. Safety labs and Pituitary MRI will be performed. 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 intramuscular (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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 12 months

Population: The study was terminated due to poor enrollment. The data was not collected or analyzed.

This is to measure the effect of Pasireotide LAR (long-acting release) treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 12 months

Population: The study was terminated due to poor enrollment. The data was not collected or analyzed.

This is to measure the effect of Pasireotide LAR (long-acting release) treatment.

Outcome measures

Outcome data not reported

Adverse Events

Pasireotide LAR Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pamela U. Freda, MD

Columbia University

Phone: 212-305-2254

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place