Acromegaly
Conditions
Keywords
Acromegaly, octreotide, CAM2029, phase 3
Brief summary
The purpose of this trial is to assess the long-term safety and efficacy of CAM2029 in patients with acromegaly. Patients will be administered CAM2029 subcutaneously once monthly during 12 months. Patients fulfilling trial NCT04076462 will be offered to continue with open-label treatment week 24-52 in this trial. Patients completing the main part of the trial will be offered 52 weeks continued open-label treatment in an extension part.
Interventions
Octreotide subcutaneous depot for monthly injections in acromegaly patients
Sponsors
Camurus AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 of (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 or IGF-1 levels ≤1xULN at screening with or without prior pituitary radiotherapy * Adequate liver, pancreatic, renal and bone marrow functions * Normal ECG
Exclusion criteria
For Roll-over Patients from NCT04076462: * Unresolved, drug-related serious adverse event (SAE) from the preceding trial * 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%)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Characterization of adverse events (AEs) | Week 0-52 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with mean IGF-1 levels ≤1xULN and <1.3xULN | Week 50 to 52 | — |
| Proportion of patients with mean GH levels <2.5 µg/L and <5.0 µg/L | Week 50 to 52 | — |
| Proportion of patients/partners declared competent by a healthcare professional to administer intervention | Week 0-52 | During patients/partners first three attempts during the trial period of 52 weeks whenever these visits take place |
| Octreotide plasma concentrations over time | Week 0-52 | — |
Countries
Germany, Greece, Hungary, Italy, Poland, Russia, Serbia, Spain, Turkey (Türkiye), United Kingdom, United States
Outcome results
None listed