Efficacy and Safety of Octreolin for Acromegaly
This study is currently recruiting participants.
Verified January 2013 by Chiasma, Inc.
Sponsor:
Chiasma, Inc.
Information provided by (Responsible Party):
Chiasma, Inc.
ClinicalTrials.gov Identifier:
NCT01412424
First received: August 5, 2011
Last updated: January 14, 2013
Last verified: January 2013
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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: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (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 40 Study Locations
Show 40 Study LocationsSponsors 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: | January 14, 2013 |
| 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 May 19, 2013