EFFICACY AND SAFETY OF ORAL OCTREOLIN™ IN PATIENTS WITH ACROMEGALY

Conditions: Acromegaly
MedDRA version: 16.0Level: PTClassification code 10000599Term: AcromegalySystem Organ Class: 10014698 - Endocrine disorders
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2011-002912-10-HU

Lead Sponsor: Chiasma, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

1.Adult subjects, aged 18 to 75 years old, inclusive, at screening visits
2.Subjects with acromegaly defined as documented evidence of GH-secreting pituitary tumor that is abnormally responsive to glucose who are currently receiving somatostatin analog.
3.Subjects able and willing to comply with the requirements of the protocol
4.Subjects able to swallow capsules
5.Subjects able to understand and sign written informed consent to participate in the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 132
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion Criteria

1.Symptomatic cholelithiasis
2.Received pituitary radiotherapy within ten years prior to screening
3.Undergone pituitary surgery within the prior 6 months
4.Clinically significant GI, renal or hepatic disease.
5.Known allergy or hypersensitivity to any of the test compounds or materials
6.Life expectancy of less than 2 years
7.Uncontrolled diabetes
8.Defects in visual fields due to optic chiasmal compression
9.Female patients who are pregnant or lactating
10.Female patients who are of childbearing potential
11.History of immunocompromise, including a positive HIV test result (ELISA and Western blot)
12.History of alcohol or drug abuse
13.Intake of an investigational drug within 30 days before patient inclusion in this study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the effect of Octreolin therapy on Insulin-like Growth Factor 1 (IGF-1) levels ;Secondary Objective: To determine the effect of Octreolin therapy on Growth Hormone (GH) levels<br>To assess the safety and tolerability of Octreolin in subjects with acromegaly <br>;Primary end point(s): The primary efficacy endpoint is the IGF-1 concentration at the end of the Core Treatment Period. ;Timepoint(s) of evaluation of this end point: End of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary efficacy endpoints is the GH concentration at the completion of the Treatment Period. The secondary safety endpoint is the safety and tolerability during the Treatment Period.;Timepoint(s) of evaluation of this end point: End of treatment