Clinical Trial: Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Cap

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 Summary:

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.

Sponsor: Chiasma, Inc.

Current Primary Outcome: IGF-1 Time Weighted Average (TWA), during the RCT phase [ Time Frame: 62 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change in acromegaly symptoms [ Time Frame: 62 weeks ]
  Acromegaly Index of Severity Score (AIS) - Headache, Swelling of extremities, Joint pain, Sweating and Fatigue, assessed by severity (0-3).
• Proportion of patients with clinical and biochemical response [ Time Frame: 62 weeks ]
  Biochemical response - IGF-1 TWA Clinical response - maintained or improved acromegaly symptoms
• Patient reported outcomes [ Time Frame: 62 weeks ]
  Acro-TSQ - newly developed and validated patient reported outcome questionnaire

Original Secondary Outcome: Same as current

Information By: Chiasma, Inc.

Dates:
Date Received: January 28, 2016
Date Started: February 2016
Date Completion: March 2019
Last Updated: March 2, 2017
Last Verified: March 2017