Phase III with Octreotide capsules/Placebo in acromegaly patients
Research type
Research Study
Full title
A phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate efficacy and safety of octreotide capsules in patients who previously tolerated and demonstrated biochemical control on injectable somatostatin receptor ligands (SRL) treatment
IRAS ID
225749
Contact name
Professor Peter James Trainer
Contact email
Sponsor organisation
Chiasma, Inc.
Eudract number
2017-000737-31
Clinicaltrials.gov Identifier
34699, CPMS ID
Duration of Study in the UK
2 years, 7 months, 1 days
Research summary
Summary of Research
Acromegaly is a rare disease leading to disproportionate growth of mainly skeleton and organs. The enlargement of the bones and tissues is due to an over production of Growth Hormone (GH) and Insulin-like Growth Factor (IGF-1), which also causes cardiovascular, respiratory, hormonal and metabolic damages. For the large majority of patients, the disease is due to a benign tumour of the pituitary gland. Although surgery of the tumour and radiotherapy are current treatments, the injection of drugs such as octreotide and lanreotide (Synthetic Somatostatin drugs, SRLs, which suppress GH over secretion in the majority of the patients) is the most widely standard of care used to control acromegaly. The development of octreotide capsules (investigational drug) as an oral treatment, would prevent the disadvantages associated with chronic injection experienced by acromegaly patients.
The purpose of the study is to evaluate the effectiveness of octreotide capsules compared to placebo on the stability of GH and IGF-1 blood level in acromegaly patients who were controlled and stable when treated with standard of care injectable SRLs. The safety of octreotide capsules compared to placebo will be also evaluated.
The study consists of two phase treatments:
- Double-blind Placebo-Controlled period (DPC) where all the qualified patients following randomisation will receive octreotide capsules or placebo twice a day for 36 weeks,
- Open Label Extension (OLE) where patients at the end of the DPC period will be able to continue with octreotide capsules until the last patient enrolled in this period completes one year or until the capsules are commercially available or Sponsor terminates the study.The study could last for a minimum of 14 months including up to 8 weeks of screening for subject eligibility.
In total, there will be about 50 subjects participating in this study around the world including approximately 4 from the UK.
Summary of Results
Chiasma, Inc, the Sponsor, is a biotechnology company, located in the United States, engaged in the development of oral medications that are currently only available as injections for rare and debilitating diseases.
Octreotide capsule is a novel, orally-administered formulation of the well-characterized and commercially-available parenteral drug octreotide.
This study was designed to evaluate the efficacy and safety of octreotide capsules in acromegaly patients who previously tolerated and demonstrated biochemical control on and injectable treatment (SRL) for at least 6 months.
The study consists of two treatment periods, the Treatment Period and the optional Extension Period and 12-week follow-up period.
Both treatment periods showed that MYCAPSSA (ocreotide capsules) were safe to use and proved to have a significant level of efficacy in maintaining the symptoms of patients with acromegaly. The safety profile of octreotide capsules is consistent with the known safety profile of octreotide.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
17/EM/0324
Date of REC Opinion
27 Oct 2017
REC opinion
Further Information Favourable Opinion