Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly

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 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

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