Overview

This trial is active, not recruiting.

Condition acromegaly
Treatment active oral octreotide study drug therapy
Phase phase 3
Sponsor Chiasma, Inc.
Start date October 2011
End date October 2014
Trial size 150 participants
Trial identifier NCT01412424, CH-ACM-01

Summary

Octreolin is a proprietary oral form of the approved injectable medical product octreotide used to treat acromegaly. This study will evaluate the efficacy and safety of Octreolin treatment in patients with acromegaly.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Active oral octreotide study drug therapy
active oral octreotide study drug therapy Octreolin
Escalation from starting dose of 40 mg/d to 60 mg/d to 80 mg/d guided by IGF-1 levels

Primary Outcomes

Measure
IGF-1 concentration
time frame: Completion of the treatment period

Secondary Outcomes

Measure
Safety and tolerability
time frame: During and at end of treatment

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Adult subjects, aged 18 to 75 years old, inclusive - Subjects with acromegaly defined as documented evidence of GH-secreting pituitary tumor that is abnormally responsive to glucose who are currently receiving a somatostatin analog - Subjects able and willing to comply with the requirements of the protocol - Subjects able to swallow capsules - Subjects able to understand and sign written informed consent to participate in the study Exclusion Criteria: - Symptomatic cholelithiasis - Received pituitary radiotherapy within ten years prior to screening - Undergone pituitary surgery within the prior 6 months - Clinically significant GI, renal or hepatic disease - Known allergy or hypersensitivity to any of the test compounds or materials - Life expectancy of less than 2 years - Uncontrolled diabetes - Defects in visual fields due to optic chiasmal compression - Female patients who are pregnant or lactating - Female patients who are of childbearing potential - History of immunocompromise, including a positive HIV test result (ELISA and Western blot) - History of alcohol or drug abuse - Intake of an investigational drug within 30 days before patient inclusion in this study

Additional Information

Official title Efficacy and Safety of Oral Octreolin™ in Patients With Acromegaly Who Are Currently Receiving Parenteral Somatostatin Analogs
Description Qualifying patients with acromegaly will receive treatment with Octreolin. Dose escalation will proceed to identify the optimal dose for each patient. The optimal dose will be continued as chronic therapy. Levels of GH and IGF-1 will be assessed during the study and at end of treatment.
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Chiasma, Inc..