Brief Title
Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly
Official Title
A Phase 3, Randomized, Active Controlled Study to Evaluate Maintenance of Response, Safety and Patient Reported Outcomes in Acromegaly Patients Treated With Octreotide Capsules vs. Parenteral Somatostatin Receptor Ligands
Brief Summary
Octreotide capsule is a novel, orally-administered formulation of the commercially-available injectable drug octreotide. In a recent phase 3 trial, oral octreotide capsules demonstrated sustained biochemical response up to 13 months in patients with acromegaly previously managed with somatostatin analog injections (ref). The purpose of this study is to compare the efficacy safety and patient reported outcomes between oral octreotide capsules and injectable somatostatin analogs.
Detailed Description
This will be a phase 3, randomized, open-label, active controlled, multicenter study to evaluate maintenance of response, safety and patient reported outcomes (PROs) in acromegaly patients treated with octreotide capsules and in patients treated with SOC parenteral SRLs, who previously tolerated and demonstrated biochemical control on both treatments. The core study will consist of three phases: a Screening phase, Run-in phase and a Randomized Controlled Treatment Phase (RCT). Eligible patients who are biochemically controlled on parenteral SRLs will be switched to octreotide capsules for a 26-week Run-in phase. During this phase the effective dose for each patient will be determined through dose titration. Patients whose acromegaly is been controlled biochemically on octreotide capsules at the end of the Run-in Phase will enter a 36-week open-label Randomized Controlled Treatment Phase, where they will be randomized to continue on octreotide capsules or switch back to their injectable SRL treatment (as received prior to Screening). Following the completion of the core study (Screening, Run-in and RCT phases), eligible patients will be offered to enter the Study Extension phase and receive octreotide capsules until product marketing or study termination. A Sub-study, in selected sites, would allow patients with in-adequate biochemical control on octreotide capsules during the Run-in Phase to enter a Combination phase and receive co-administration of octreotide capsules with cabergoline tablets for a total of 36 weeks.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
IGF-1 Time Weighted Average (TWA), during the RCT phase
Secondary Outcome
Change in acromegaly symptoms
Condition
Acromegaly
Intervention
Octreotide capsules
Study Arms / Comparison Groups
Run-in phase
Description: Oral octreotide capsules
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
150
Start Date
February 2016
Completion Date
February 2021
Primary Completion Date
August 2020
Eligibility Criteria
Inclusion Criteria: - Confirmed diagnosis of acromegaly - Treatment with Somatostatin analogs injections (octreotide or lanreotide) for at least 6 months - Biochemical control (IGF -1 < 1.3 x ULN and GH < 2.5ng/mL) Exclusion Criteria: - Injections of long-acting somatostatin analogs, at a dosing interval > 8 weeks. - Pituitary radiotherapy within 5 years - Pituitary surgery within six months - Patients who previously participated in CH-ACM-01 study - Any clinically significant uncontrolled concomitant disease - Symptomatic cholelithiasis - Previous treatment with: - Pegvisomant, within 12 weeks - Dopamine agonists, within 6 weeks - Pasireotide, within 12 weeks
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Maria Fleseriu, M.D., FACE, ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT02685709
Organization ID
OOC-ACM-302
Secondary IDs
2015-002854-11
Responsible Party
Sponsor
Study Sponsor
Chiasma, Inc.
Study Sponsor
Maria Fleseriu, M.D., FACE, Study Chair, Northwest Pituitary Center, Oregon Health & Science University , Portland, OR, USA
Verification Date
August 2019