Phase 3
N=155
Efficacy and Safety of Octreotide (MYCAPSSA™ [Formerly Octreolin™]) for Acromegaly
Acromegaly
Bottom Line
View on ClinicalTrials.gov: NCT01412424 ↗Enrolled (actual)
155
Serious AEs
7.9%
Results posted
Dec 2015
Primary outcome: Primary: Percentage of Responders at the End of the Core Treatment Period — 86.9; 66.7; 40.4; 64.9 Percentage of responders
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Octreotide capsules (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Chiasma, Inc.
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Responders at the End of the Core Treatment Period |
86.9; 66.7; 40.4; 64.9 | — |
| PRIMARY Percentage of Responders at the End of the Extension Treatment Period |
78.4 | — |
| SECONDARY Percentage of Participants With Specified IGF-1 and GH Concentrations at Baseline and at the End of the Core Treatment Period |
91.4; 65.6; 62.9; 53.0; 63.6; 35.8 | — |
| SECONDARY Maintenance of Response During the Fixed Dose Phase of the Core Treatment Period |
82.7; 80.0 | — |
| SECONDARY Percentage of Participants With Specified IGF-1 and GH Concentrations at the Beginning and at the End of the Extension Treatment Period |
84.1; 79.5; 69.3; 68.2; 48.9; 50.0 | — |
| SECONDARY Maintenance of Response During the Extension Treatment Period |
87.8 | — |
| SECONDARY Percentage of Participants With Improved or Maintained Acromegaly Symptoms at the End of the Extension Treatment Period |
27; 57 | — |
| SECONDARY Percentage of Participants With ≥ 1, 2, or 3 Acromegaly Symptoms at Baseline and at the End of the Extension Treatment Period |
78; 65; 61; 43; 43; 25 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01412424). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.