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 (OPTMAL; NCT03252353), oral octreotide
      capsules demonstrated sustained biochemical response up to 13 months in patients with
      acromegaly previously managed with somatostatin analog injections (ref).

      The objective of this study was to compare the efficacy, safety, and patient reported
      outcomes (PROs) between oral octreotide capsules and injectable somatostatin receptor ligands
      (SRLs).
    

Detailed Description

      This was phase 3, randomized, open-label, active controlled, multicenter study to evaluate
      the maintenance of response, safety and patient reported outcomes (PROs) in acromegaly
      patients treated with octreotide capsules and in patients treated with standard of care
      parenteral somatostatin receptor ligands (SRLs), who previously tolerated and demonstrated
      biochemical control on both treatments.

      The core study consisted of three phases: a Screening phase, Run-in phase and a Randomized
      Controlled Treatment (RCT) phase.

      Eligible patients who were biochemically controlled on parenteral SRLs were switched to
      octreotide capsules for a 26-week period Run-in phase. During this phase the effective dose
      for each patient was determined through dose titration.

      Patients whose acromegaly has been controlled biochemically on octreotide capsules at the end
      of the Run-in phase entered a 36-week open-label RCT phase, where they 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 were offered to enter the Study Extension phase and receive octreotide capsules
      until product marketing or study termination.

      A Sub-study, performed in selected non-European sites, allowed patients with inadequate
      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

Proportion of Patients Who Are Biochemically Controlled Throughout the RCT Phase

Secondary Outcome

 Proportion of Patients With Clinical and Biochemical Control at the End of the RCT Phase

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

146

Start Date

February 2016

Completion Date

August 2021

Primary Completion Date

October 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

March 2022