Acromegaly MedDRA version: 20.0 Level: PT Classification code 10000599 Term: Acromegaly System Organ Class: 10014698 - Endocrine disorders
Conditions
Sponsors
Camurus AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female patients, =18 years at screening - Able to provide written informed consent to participate in the trial prior to any trial related procedures are performed - 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 at screening - Adequate liver, pancreatic, renal and bone marrow 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 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: - GH =2.5 µg/L at screening (cycle) • 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 • Patients with poorly controlled diabetes mellitus (hemoglobin A1c >8.0%)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To assess maintenance of biochemical control of CAM2029 compared to placebo;Secondary Objective: -to assess maintenance of biochemical control, based on GH, with CAM2029 compared to placebo; -To evaluate the safety profile of CAM2029 compared to placebo -To assess self or partner administration -To assess plasma concentrations of octreotide after administration of CAM2029 ;Primary end point(s): • Proportion of patients with mean IGF-1 levels =1x upper limit of normal (ULN) at Week 22 and Week 24 (average of the 2 measurements);Timepoint(s) of evaluation of this end point: Week 22 and Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Proportion of patients with mean GH cycle levels <2.5 µg/L at Week 24 - Proportion of patients/partners declared competent by healthcare professional to administer CAM2029 or placebo -Incidence of adverse events (AEs) and laboratory and electrocardiogram (ECG) abnormalities - Octreotide plasma concentrations over time ;Timepoint(s) of evaluation of this end point: Week 22 and Week 24 | — |
Countries
Bulgaria, Germany, Greece, Hungary, Italy, Netherlands, Poland, Russian Federation, Serbia, Spain, Sweden, Turkey, United Kingdom, United States
Contacts
Public Contactregulatory unit
Accelsiors CRO and Consultancy Services Ltd
Outcome results
None listed