A phase 3 study (late stage development study), that compares the efficacy and safety of octreotide capsules to placebo in acromegaly patients

Phase 1

Conditions: Acromegaly
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2017-000737-31-IT

Lead Sponsor: CHIASMA INC.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 50

Inclusion Criteria

1. Adult subjects, aged =18 years old at the first Screening visit.
2. Patients with active acromegaly, defined as documented evidence of GHsecreting
pituitary tumor based on MRI/Pathology report and documented
evidence of IGF-1 levels =1.3 × ULN. This needs to be at least 3 months
following pituitary surgery in those patients who had prior pituitary surgery.
3. Received parenteral SRL monotherapy (octreotide or lanreotide but not
pasireotide) for at least 6 months with a stable dose for at least the last three
months of therapy.
4. Average IGF-1 of 2 assessments obtained during the Screening period is
=1 × ULN.
5. Patients able and willing to comply with the requirements of the protocol at
the time of Screening.
6. Women who are of childbearing potential should use an acceptable method
for birth control. Acceptable methods include hormonal contraception (oral
contraceptives – as long as on stable dose, patch, implant, and injection),
intrauterine devices, or double barrier methods (e.g. vaginal diaphragm/
vaginal sponge plus condom, or condom plus spermicidal jelly), sexual
abstinence2 or a vasectomized partner. Women may be surgically sterile or at least 1-year post-last menstrual period. Women taking oral contraception
containing levonorgestrel should either change treatment (at least one month
prior to first study medication dose) or use a mechanical barrier method.
7. Patients able to understand and sign written informed consent to participate in
the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1. Patients taking injections of long-acting SRLs off label (unlabeled doses or
dosing interval. e.g. 60 or 90mg lanreotide every 8 weeks or 30 mg octreotide
every 6 or 8 weeks).
2. Patients who previously participated in CH-ACM-01 or OOC-ACM-302
(MPOWERED study).
3. Symptomatic cholelithiasis.
4. Conventional or stereotactic radiotherapy any time in the past
5. Undergone pituitary surgery within six months prior to screening or have
elective pituitary surgery (or other elective surgery that may affect
compliance with protocol or confound study outcomes), planned within the
course of the core study.
6. High-risk pattern3 of pituitary tumor location on pituitary MRI/Computed
tomography (CT) as per medical history or most recent MRI/CT.
7. History of unstable angina or acute myocardial infarction within the 12 weeks
preceding the screening visit or other clinically significant cardiac disease at
the time of screening as judged by the Principal Investigator.
8. Any clinically significant uncontrolled nervous system, gastrointestinal (GI),
renal, pulmonary, or hepatic concomitant disease that in the Investigator’s
opinion would preclude patient participation.
9. Evidence of active malignant disease or malignancies diagnosed within the
previous one year (except for basal cell carcinoma and uncomplicated – up to
stage 1 squamous cell carcinoma that has been excised and cured).
10. Known allergy or hypersensitivity to any of the test compounds or materials.
11. Known uncontrolled diabetes defined as having a fasting glucose
> 150 mg/dL (8.3 mmol/L) or glycosylated hemoglobin (HbA1c) = 8%
(patients can be rescreened after diabetes is brought under adequate control,
or in case HbA1c < 8%).
12. Known defects in visual fields due to optic chiasmal compression or other
neurological signs, related to the pituitary tumor mass. Patients withlong-standing (>12 months), fixed, minor defects may be considered on a
case-by-case basis after consultation with the medical monitor.
13. Female patients who are pregnant or lactating or intending to become
pregnant during the study.
14. Known history of immunodeficiency (e.g., HIV positive).
15. Alanine transaminase (ALT), aspartate aminotransferase (AST) or alkaline
phosphatase (ALP) > 3 × ULN or total bilirubin >1.5 × ULN.
16. Undergone major surgery/surgical therapy for any cause within four weeks
prior to enrollment or planned procedure during the study.
17. Known hypothyroidism or hypocortisolism not adequately treated with a
stable dose of thyroid or steroid hormone replacement therapy for = 12
weeks.
18. Any condition that may jeopardize study participation (e.g., clinically
significant abnormal screening clinical or laboratory finding during
screening), the interpretation of study results or may impede the ability to
obtain informed consent (e.g., mental condition).
19. History of illicit drug or alcohol abuse within five years.
20. Intake of an investigational drug within 30 days prior to initiation of study
treatment.
21. Treatment with pegvisomant within 24 weeks before the first screening visit.
22. Treatment with dopamine agonists within 12 weeks before the first screening
visit.
23. Treatment with pasireotide within 24 weeks before the first screening visit.