A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly
- Conditions
- Acromegaly
- Interventions
- Drug: CAM2029 (octreotide subcutaneous depot)Drug: Matching placebo
- Registration Number
- NCT04076462
- Lead Sponsor
- Camurus AB
- Brief Summary
The purpose of this trial is to assess the efficacy and safety of CAM2029 in patients with acromegaly. Patients will be randomized to either CAM2029 or placebo administered subcutaneously once monthly during 6 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
- 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
- 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%)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CAM2029 (octreotide subcutaneous depot) CAM2029 (octreotide subcutaneous depot) CAM2029 (octreotide subcutaneous depot) 20mg/1.0 mL for 20 mg dose, subcutaneous injection once monthly, six months treatment. If down-titration is required, 10mg/0.5 mL for 10 mg dose is available. Matching placebo Matching placebo Placebo (subcutaneous depot) 1.0 mL, subcutaneous injection once monthly, six months treatment. If down-titration is required, 0.5 mL dose is available.
- Primary Outcome Measures
Name Time Method Proportion of patients with mean IGF-1 levels ≤1xULN Week 22 and 24
- Secondary Outcome Measures
Name Time Method Proportion of patients with mean GH levels <2.5 µg/L Week 24 Proportion of patients/partners declared competent by a healthcare professional to administer intervention Week 0 to 20 and week 24 During patients/partners first three attempts during the trial period of 24 weeks whenever these visits take place
Proportion of patients with mean IGF-1 levels ≤1xULN, including patients with dose reduction Week 22 and 24 Incidence of treatment emergent adverse events Week 0 to 24 Proportion of patients with mean GH levels <1.0 µg/L Week 24 Octreotide plasma concentrations over time Week 0 to 24 Proportion of patients with mean IGF-1 levels ≤1xULN at Week 22/Week 24 and mean GH levels <2.5 µg/L at Week 24 Week 22 and 24
Trial Locations
- Locations (62)
UCLA Department of Medicine Division of Endocrinology
🇺🇸Los Angeles, California, United States
Stanford University Medical Center
🇺🇸Palo Alto, California, United States
Prufen Clinical Research LLC
🇺🇸Miami, Florida, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Washington University in St. Louis, School of Medicine
🇺🇸Saint Louis, Missouri, United States
Palm Research Center
🇺🇸Las Vegas, Nevada, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
Scroll for more (52 remaining)UCLA Department of Medicine Division of Endocrinology🇺🇸Los Angeles, California, United States