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 prior 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 -To measure patients' satisfaction with CAM2029 and placebo -To measure the effects of CAM2029 and placebo on quality of life ;Primary end point(s): • Proportion of patients with biochemical response, defined as 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 with mean GH cycle levels <1.0 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 - Treatment Satisfaction Questionnaire for Medication (TSQM) scores over time using all 4 domains of TSQM (effectiveness, side effects, convenience and satisfaction) - Patient satisfaction scale scores at Week 24 - Change from baseline in Acromegaly Quality of Life Questionnaire (AcroQoL) and EuroQoL 5-dimension 5-level (EQ-5D-5L) scores ;Timepoint(s) of evaluation of this end point: Week 22 and Week 24 | — |
Countries
Germany, Greece, Hungary, Italy, Poland, Russian Federation, Spain, Sweden, Turkey, United Kingdom, United States
Contacts
Public Contactregulatory unit
Accelsiors CRO and Consultancy Services Ltd
Outcome results
None listed