Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly

Description

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 maintenance of biochemical response up to 13 months in the majority of patients with acromegaly previously managed with somatostatin analog injections (reference below).

Study Start Date

September, 01 2017

Estimated Completion Date

May 2020

Interventions

  • Drug: octreotide capsules
  • Drug: Matching placebo

Study ID

Chiasma, Inc. -- OOC-ACM-303

Status

Recruiting

Trial ID

NCT03252353

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

50

Sponsor

Chiasma, Inc.

Inclusion Criteria

  • Documented evidence of active acromegaly
  • Treatment with Somatostatin analogs injections (octreotide or lanreotide) for at least 6 months with a stable dose for at least the last three months of therapy
  • Biochemically controlled

Exclusion Criteria

  • Patients taking injections of long-acting SRLs not as indicated in the label
  • Pituitary surgery within six months
  • Conventional or stereotactic pituitary radiotherapy any time in the past
  • Patients who previously participated in CH-ACM-01 or OOC-ACM-302
  • Any clinically significant uncontrolled concomitant disease
  • Symptomatic cholelithiasis
  • Pegvisomant, within 24 weeks
  • Dopamine agonists, within 12 weeks
  • Pasireotide, within 24 weeks

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (30)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None
Columbia University Medical Center - New York, New York 181.2 miles None None None
Memorial Sloan Kettering Cancer Center - New York, New York 187.1 miles None None None
RutgersRobert Wood Johnson Medical School - New Brunswick, New Jersey 217.0 miles None None None
RutgersRobert Wood Johnson Medical School - New Brunswick, New Jersey 217.0 miles None None None
RutgersRobert Wood Johnson Medical School - New Brunswick, New Jersey 217.0 miles None None None
RutgersRobert Wood Johnson Medical School - New Brunswick, New Jersey 217.0 miles None None None
Johns Hopkins University Clinical Trials Unit - Baltimore, Maryland 356.0 miles None None None
Allegheny Endocrinology Associates - Pittsburgh, Pennsylvania 480.9 miles None None None
Cleveland Clinic - Cleveland, Ohio 544.9 miles None None None
Ohio State University - Columbus, Ohio 640.0 miles None None None
Northwestern University - Chicago, Illinois 847.9 miles None None None
John H Stroger Jr Hospital of Cook County - Chicago, Illinois 851.3 miles None None None
John H Stroger Jr Hospital of Cook County - Chicago, Illinois 851.3 miles None None None
John H Stroger Jr Hospital of Cook County - Chicago, Illinois 851.3 miles None None None
John H Stroger Jr Hospital of Cook County - Chicago, Illinois 851.3 miles None None None
The Emory Clinic - Atlanta, Georgia 932.0 miles None None None
Washington University School of Medicine - Saint Louis, Missouri 1,039.5 miles None None None
University of Alabama at Birmingham - Birmingham, Alabama 1,052.1 miles None None None
Baylor College of Medicine - Houston, Texas 1,609.9 miles None None None
University of Colorado - Aurora, Colorado 1,759.8 miles None None None
Huntsman Cancer Hospital - Salt Lake City, Utah 2,093.0 miles None None None
Oregon Health and Science University - Portland, Oregon 2,538.3 miles None None None
Keck Medical Center of University of Southern California - Los Angeles, California 2,593.7 miles None None None
CedarsSinai Medical Center - Los Angeles, California 2,601.4 miles None None None
CedarsSinai Medical Center - Los Angeles, California 2,601.4 miles None None None
CedarsSinai Medical Center - Los Angeles, California 2,601.4 miles None None None
CedarsSinai Medical Center - Los Angeles, California 2,601.4 miles None None None
UCLA Medical Center - Los Angeles, California 2,605.2 miles None None None
Stanford University School of Medicine - Palo Alto, California 2,694.6 miles None None None

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