Efficacy and Safety of Octreotide (MYCAPSSA™ [Formerly Octreolin™]) for Acromegaly

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

MYCAPSSA™ (formerly 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 MYCAPSSA™ treatment in patients with acromegaly.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiasma, Inc.
• Treatments: Octreotide; Somatostatin

Criteria

Inclusion Criteria:

• Adult subjects, aged 18 to 75 years old, inclusive.

• Subjects with acromegaly defined as documented evidence of growth hormone-secreting pituitary tumor that is abnormally responsive to glucose, or documented elevated insulin-like growth factor-1 (IGF-1), who are currently receiving a stable dose of a somatostatin analog for at least the previous 3 months.

• A serum IGF-1 level < 1.3 x the upper limit of normal (ULN) and a serum growth hormone (GH) level < 2.5 ng/mL.

• 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:

• Receiving regular injections of a somatostatin analog less frequently than once a month, ie, longer than every 4 weeks.

• Symptomatic cholelithiasis.

• Received pituitary radiotherapy within ten years prior to screening.

• Undergone pituitary surgery within the prior 6 months.

• Any condition that may jeopardize study participation.

• Clinically significant gastrointestinal (GI), renal, or hepatic disease as determined by the Investigator.

• Conditions (eg, bariatric surgery) significantly affecting gastric acidity or emptying.

• Current use (within 1 month) of proton pump inhibitors (PPIs) and current chronic use of H2-antagonists.

• Female patients who are pregnant or lactating.

• Current or recent (< 3 months) therapy with pegvisomant.

• Current or recent (< 2 months) therapy with cabergoline.