Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly



Status:Recruiting
Conditions:Skin Cancer, Endocrine
Therapuetic Areas:Endocrinology, Oncology
Healthy:No
Age Range:18 - 75
Updated:12/14/2018
Start Date:February 2016
End Date:February 2021
Contact:Engage Health
Phone:+1-855-676-9733

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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

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
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Phone: 410-955-2812
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Phone: 404-778-3746
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-726-7473
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Phone: 713-798-3076
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Phone: 310-423-0022
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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291 Campus Dr
Stanford, California 94305
(650) 725-3900
Stanford University School of Medicine Vast in both its physical scale and its impact on...
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Phone: 720-848-5146
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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303 East Superior Street
Chicago, Illinois 60611
Phone: 312-908-9002
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1969 W Ogden Ave
Chicago, Illinois 60612
(312) 864-6000
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John H. Stroger, Jr. Hospital of Cook County The Level 1 Trauma Center is one...
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
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Houston, Texas 77030
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Las Vegas, Nevada 89102
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Nashville, Tennessee 37203
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New Brunswick, New Jersey 08903
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630 W 168th St
New York, New York
212-305-2862
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Phone: 215-955-1925
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Pittsburgh, Pennsylvania 15212
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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