Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly (MPOWERED)

Chiasma, Inc.

Status and phase: Completed; Phase 3

Conditions: Acromegaly

Treatments: Drug: Octreotide capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT02685709

2015-002854-11 (EudraCT Number)

OOC-ACM-302

Details and patient eligibility

About

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).

Full 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.

Enrollment: 146 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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146 participants in 4 patient groups

Run-in phase

Experimental group

Description:

Oral octreotide capsules

Treatment:

Drug: Octreotide capsules

RCT phase - Oral

Experimental group

Description:

Oral octreotide capsules

Treatment:

Drug: Octreotide capsules

RCT phase - Injectables

Active Comparator group

Description:

Injectable somatostatin analogs (octreotide or lanreotide)

Treatment:

Drug: Octreotide capsules

Combination phase (sub-study)

Experimental group

Description:

Octreotide capsules plus cabergoline

Treatment:

Drug: Octreotide capsules