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-PL
• Lead Sponsor: Camurus AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-02
• Last Update Posted: 21 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Main part of the trial:
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 screening (adjusted for age and sex; value of the first measurement at
screening and the second measurement at 2 weeks before Day 1) either without prior pituitary radiotherapy or with prior pituitary radiotherapy
Adequate liver, pancreatic, renal and bone marrow functions
Normal ECG
Extension Part of the Trial:
Continuation Criteria for Patients who Continue Directly to the Extension Part of the Trial
Patients who continue directly from the main part of the trial must complete treatment with CAM2029 in the main part of the trial, attend the Week 52 visit, and provide written informed consent to continue treatment in the extension part of the trial before treatment can be continued.
Main Inclusion Criteria for Re-invited Patients:
Completed treatment with CAM2029 in the main part of the trial and attended the Week 52 visit
Adequate liver, pancreatic and renal functions
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

Main part of the trial:
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 prior to 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 [HbA1c] >8.0%)
Main Exclusion Criteria for Re-invited Patients -Extension Part of the Trial:
• Receiving treatments (other than treatments for acromegaly) known to affect GH or IGF-1
concentration
• Patients who have undergone major surgery/surgical therapy (including pituitary surgery) for
any cause within 1 month prior to screening
• Patients who have received pituitary irradiation since the end of the main part of the trial
• Patients with poorly controlled diabetes mellitus (HbA1c >8.0%)

Study & Design

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