Trial Outcomes & Findings for Tissue Biomarker for Pegvisomant Action (NCT NCT01261000)

Results Overview

Induction of colon tissue expression of p53, a tumor suppressor, using Western blot analysis, after GH receptor blockade with pegvisomant

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

8 weeks

Results posted on

2017-08-22

Participant milestones
Measure	Pegvisomant Pegvisomant: Pegvisomant used as indicated
Overall Study STARTED	8
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	1

Reasons for withdrawal
Measure	Pegvisomant Pegvisomant: Pegvisomant used as indicated
Overall Study Screen failure	1

Tissue Biomarker for Pegvisomant Action

Baseline characteristics by cohort
Measure	Pegvisomant n=7 Participants Pegvisomant: Pegvisomant used as indicated
Age, Continuous	50 years STANDARD_DEVIATION 21 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants

Timeframe: 8 weeks

Induction of colon tissue expression of p53, a tumor suppressor, using Western blot analysis, after GH receptor blockade with pegvisomant

Outcome measures
Measure	Pegvisomant n=7 Participants Pegvisomant: Pegvisomant used as indicated
Effect of Pegvisomant on Colon Tissue p53 Expression	330.57 ng/mL Standard Deviation 107.33

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	Pegvisomant n=8 participants at risk Pegvisomant: Pegvisomant used as indicated
Cardiac disorders Bacterial endocarditis	12.5% 1/8 • Number of events 1 • 8 months
Nervous system disorders Vertigo	12.5% 1/8 • Number of events 1 • 8 months

Adverse event data not reported

Cedars-Sinai Medical Center

Phone: 424-315-4489