Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly
Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly
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.
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.
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