Efficacy and Safety of Octreolin for Acromegaly

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Chiasma, Inc.
ClinicalTrials.gov Identifier:
NCT01412424
First received: August 5, 2011
Last updated: March 25, 2014
Last verified: January 2013
  Purpose

Octreolin is a proprietary oral form of the approved injectable medical product octreotide used to treat acromegaly. This study will evaluate the efficacy and safety of Octreolin treatment in patients with acromegaly.


Condition Intervention Phase
Acromegaly
Drug: Active oral octreotide study drug therapy
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Oral Octreolin™ in Patients With Acromegaly Who Are Currently Receiving Parenteral Somatostatin Analogs

Resource links provided by NLM:


Further study details as provided by Chiasma, Inc.:

Primary Outcome Measures:
  • IGF-1 concentration [ Time Frame: Completion of the treatment period ] [ Designated as safety issue: No ]
    Efficacy will be assessed at the end of 7 months of study drug treatment. Age-normalized IGF-1 concentration is the treatment goal.


Secondary Outcome Measures:
  • Safety and tolerability [ Time Frame: During and at end of treatment ] [ Designated as safety issue: Yes ]
    The following measures will be assessed serially during the 7-month treatment period: Number and type of adverse events, vital signs, physical examination, blood hematology and chemistry laboratory assessments


Estimated Enrollment: 150
Study Start Date: October 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Octreolin
Active oral octreotide study drug therapy
Drug: Active oral octreotide study drug therapy
Escalation from starting dose of 40 mg/d to 60 mg/d to 80 mg/d guided by IGF-1 levels
Other Name: Octreolin

Detailed Description:

Qualifying patients with acromegaly will receive treatment with Octreolin. Dose escalation will proceed to identify the optimal dose for each patient. The optimal dose will be continued as chronic therapy. Levels of GH and IGF-1 will be assessed during the study and at end of treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult subjects, aged 18 to 75 years old, inclusive
  • Subjects with acromegaly defined as documented evidence of GH-secreting pituitary tumor that is abnormally responsive to glucose who are currently receiving a somatostatin analog
  • Subjects able and willing to comply with the requirements of the protocol
  • Subjects able to swallow capsules
  • Subjects able to understand and sign written informed consent to participate in the study

Exclusion Criteria:

  • Symptomatic cholelithiasis
  • Received pituitary radiotherapy within ten years prior to screening
  • Undergone pituitary surgery within the prior 6 months
  • Clinically significant GI, renal or hepatic disease
  • Known allergy or hypersensitivity to any of the test compounds or materials
  • Life expectancy of less than 2 years
  • Uncontrolled diabetes
  • Defects in visual fields due to optic chiasmal compression
  • Female patients who are pregnant or lactating
  • Female patients who are of childbearing potential
  • History of immunocompromise, including a positive HIV test result (ELISA and Western blot)
  • History of alcohol or drug abuse
  • Intake of an investigational drug within 30 days before patient inclusion in this study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01412424

  Show 39 Study Locations
Sponsors and Collaborators
Chiasma, Inc.
Investigators
Study Chair: Shlomo Melmed, MD Cedars-Sinai Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Chiasma, Inc.
ClinicalTrials.gov Identifier: NCT01412424     History of Changes
Other Study ID Numbers: CH-ACM-01
Study First Received: August 5, 2011
Last Updated: March 25, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Hungary: GYEMSZI
Israel: Ministry of Health
Italy: The Italian Medicines Agency - AIFA
Lithuania: State medicines control agency
Mexico: Federal Commission for Protection Against Health Risks
Netherlands: CBG-NEB
Poland: The office for registration of medical products, medical devices and biocidal products
Romania: Ministry of Health
Serbia: Medicines and Medical Devices Agency of Serbia
Slovakia: SUKL
Slovenia: Public Agency for Medicinal Products and Medical Devices (JAZMP)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Chiasma, Inc.:
acromegaly
IGF-1
growth hormone
Octreolin
octreotide
somatostatin analog

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
Somatostatin
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014