A trial to assess the long-term safety of octreotide subcutaneous depot in patients with acromegaly

Phase 1

• Conditions: Acromegaly; MedDRA version: 20.0Level: PTClassification code 10000599Term: AcromegalySystem Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2019-002190-66-HU
• Lead Sponsor: Camurus AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-30
• Last Update Posted: 11 May 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Male or female patients > =18 years at screening
Able to provide written informed consent to participate in the trial
Diagnosis of acromegaly by historical evidence (persistent or recurrent) acromegaly
Treatment with a stable dose of octreotide LAR or lanreotide ATG for at least 3 months as monotherapy prior to screening
IGF-1 levels >1xULN and =2.0xULN at screening (adjusted for age and sex; mean value of
the first measurement at screening and the second measurement at 2 weeks before Day 1) or IGF-1 levels <=1xULN at screnning (adjusted for age and sex; value of the first measurement at screening and the second measurement at 2 weeks before Day 1),with prior pituitary radiotherapy
Adequate liver, pancreatic, renal and bone marrow f unctions
Normal ECG
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 124
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

Exclusion Criteria

For Roll-over Patients from Trial HS-18-633:
• Unresolved, drug-related serious adverse event (SAE) from the preceding trial (HS-18-633)
• Patients with a clinically significant or unstable medical or surgical condition that may preclude safe and complete trial participation
For New Patients:
• Have received medical treatment for acromegaly with pasireotide (within 6 months prior to screening), pegvisomant (within 3 months prior to screening), dopamine agonists (within 3 months prior to screening) or other investigational agents (within 30 days or 5 half-lives prior to screening [whichever is longer])
• Patients who usually take octreotide LAR or lanreotide ATG less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks)
• Patients with compression of the optic chiasm causing any visual field defect for whom surgical intervention is indicated
• Patients who have undergone major surgery/surgical therapy for any cause within 1 month from screening
• Patients who have undergone pituitary surgery within 6 months prior to screening
• Patients who have received prior pituitary irradiation within 3 years prior to screening
• Patients with poorly controlled diabetes mellitus (hemoglobin A1c >8.0%)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified