A trial to assess the long-term safety of octreotide subcutaneous depot in patients with acromegaly
- Conditions
- AcromegalyMedDRA version: 20.0Level: PTClassification code 10000599Term: AcromegalySystem Organ Class: 10014698 - Endocrine disordersTherapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2019-002190-66-IT
- Lead Sponsor
- Camurus AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 140
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 =1.3xULN at screening or IGF-1 levels <=1xULN at screnning 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
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
- Primary Outcome Measures
Name Time Method Main Objective: • To assess the overall safety and tolerability of CAM2029;Secondary Objective: To assess efficacy of CAM2029 based on biochemical characteristics.<br>To assess self-and partner administration <br>To assess plasma concentration of octreotide after administration of CAM2029;Primary end point(s): • Characterization of adverse events (AEs) ;Timepoint(s) of evaluation of this end point: 52 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Proportion of patients with mean IGF-1 levels =1 x upper limit of<br>normal (ULN) and =1.3xULN at Week 50 and Week 52<br>• Proportion of patients with mean GH levels <2.5 µg/L and <5.0 µg/L at Week 50 and Week 52<br>- Proportion of patients/partners declared competent by healthcare professional to administer CAM2029 <br>- Octreotide plasma concentrations over time<br>;Timepoint(s) of evaluation of this end point: Week 50 and Week 52