Acromegaly MedDRA version: 20.0 Level: PT Classification code 10000599 Term: Acromegaly System Organ Class: 10014698 - Endocrine disorders
Conditions
Interventions
Product Name: CAM2029 (Octreotide subcutaneous depot)_ prefilled syringe
Product Code: CAM2029
Pharmaceutical Form: Prolonged-release solution for injection
INN or Proposed INN: octreotide
Current Spo
Sponsors
Camurus AB
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 16
Exclusion criteria
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%)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main part of the trail: • To assess the overall safety and tolerability of CAM2029 Extension part of the trial: • To assess the overall safety and tolerability of CAM2029;Secondary Objective: Main part of the trial: To assess efficacy of CAM2029 based on biochemical characteristics. To assess self-and partner administration To assess plasma concentration of octreotide after administration of CAM2029 To measure patients' satisfaction with CAM2029 To measure the effects of CAM2029 on quality of life (QoL) Extension part of the trial: To assess efficacy of CAM2029 based on biochemical characteristics. To evaluate patients' satisfaction with CAM2029 To evaluate the effects of CAM2029 on QoL To evaluate the effects of CAM2029 on health economic outcomes To evaluate solicited safety assessments after treatment with CAM2029;Primary end point(s): Main part of the trial: • Characterization of adverse events (AEs) Extension Part of the Trial: • Characterization of AEs;Timepoint(s) of evaluation of this end point: 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Main part of the trial: • Proportion of patients with mean IGF-1 levels =1 x upper limit of normal (ULN) and <1.3xULN at Week 50 and Week 52 (average of the 2 measurements) • Proportion of patients with mean GH levels <2.5 µg/L and <5.0 µg/L at Week 52 - Proportion of patients/partners declared competent by healthcare professional to administer CAM2029 • 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 and Week 52 • Change from baseline in Acromegaly Quality of Life Questionnaire (AcroQoL) and EuroQoL 5-dimension 5-level (EQ-5D-5L) scores Extension Part of the Trial: • IGF-1 levels over time • GH levels over time • TSQM scores over time using all 4 domains of TSQM (effectiveness, side effects, convenience, and satisfaction) • AcroQoL, EQ-5D-5L and Short Form-36 (SF-36) scores over time • Work Productivity and Activity Impairment (WPAI) scores over time • Laboratory values, vital signs, ECG readings and gallbladder imaging over time ;Timepoint(s) of evaluation of this end point: Main part of the trial: Week 50 and Week 52 Extension Part of the Trial: Through the extension period | — |
Countries
Germany, Greece, Hungary, Italy, Poland, Russian Federation, Serbia, Spain, Türkiye, United Kingdom, United States
Contacts
Public Contactregulatory unit
Accelsiors CRO and Consultancy Services Ltd
Outcome results
None listed