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Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly (OPTIMAL)

This study is currently recruiting participants.
Verified August 2017 by Chiasma, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03252353
First Posted: August 17, 2017
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Chiasma, Inc.
  Purpose
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).

Condition Intervention Phase
Acromegaly Drug: octreotide capsules Drug: Matching placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate Efficacy and Safety of Octreotide Capsules in Patients Who Demonstrated Biochemical Control on Injectable Somatostatin Receptor Ligands (SRL) Treatment

Resource links provided by NLM:


Further study details as provided by Chiasma, Inc.:

Primary Outcome Measures:
  • Proportion of patients who maintain their biochemical response at the end of the double blind placebo controlled period [ Time Frame: Week 36 ]
    IGF-1 levels <=1 ULN


Secondary Outcome Measures:
  • Proportion of patients who maintain Growth Hormone (GH) response at the end of the double blind placebo controlled period [ Time Frame: Week 36 ]
    GH < 2.5ng/mL

  • Time to loss of response (IGF-1>1xULN) [ Time Frame: Week 36 ]
    IGF-1>1 ULN

  • Time to loss of response (IGF-1>=1.3xULN) [ Time Frame: Week 36 ]
    IGF-1>=1.3 ULN

  • Change in GH from Baseline to end of treatment [ Time Frame: Week 36 ]
    Descriptive change

  • Change in IGF-1 from Baseline to end of treatment [ Time Frame: Week 36 ]
    Descriptive change


Estimated Enrollment: 50
Actual Study Start Date: September 1, 2017
Estimated Study Completion Date: May 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Octreotide capsules
Octreotide capsules
Drug: octreotide capsules
octreotide capsules 40mg/day, 60mg/day, 80 mg/day (individual dose titration)
Other Name: MYCAPSSA
Placebo Comparator: Matching Placebo
Matching placebo capsules
Drug: Matching placebo
Matching placebo capsules
Other Name: Placebo

Detailed Description:

This is a double blind, randomized study that assesses the efficacy and safety of octreotide capsules vs. placebo. Eligible acromegaly patients, treated with injectable somatostatin analogs, who are biochemically controlled and have prior evidence of active disease, will be randomized to receive either octreotide capsules or placebo for up to 36 weeks. At the end of this double blind, placebo controlled period, eligible patients will receive octreotide capsules in an open-labeled extension for at least one year. Patients failing to respond (per protocol), to oral treatment, (either placebo or octreotide capsules), will be rescued with the standard of care and upon meeting the eligibility criteria could also enroll into the long term extension with octreotide capsules.

This study received agreement from the FDA, under a special protocol assessment.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03252353


Contacts
Contact: Engage Health +1-855-676-9733 OPTIMALstudy@engagehealth.com

  Show 55 Study Locations
Sponsors and Collaborators
Chiasma, Inc.
Investigators
Study Chair: Susan L Samson, MD PhD Pituitary Center at Baylor St. Luke's Medical
  More Information

Additional Information:
Publications:
Responsible Party: Chiasma, Inc.
ClinicalTrials.gov Identifier: NCT03252353     History of Changes
Other Study ID Numbers: OOC-ACM-303
First Submitted: August 10, 2017
First Posted: August 17, 2017
Last Update Posted: November 17, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chiasma, Inc.:
Octreotide Capsules, Acromegaly, OPTIMAL, MYCAPSSA

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Octreotide
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents