Brief Title
A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly
Official Title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients With Acromegaly
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Proportion of patients with mean IGF-1 levels ≤1xULN
Secondary Outcome
Proportion of patients with mean GH levels <2.5 µg/L
Condition
Acromegaly
Intervention
CAM2029 (octreotide subcutaneous depot)
Study Arms / Comparison Groups
CAM2029 (octreotide subcutaneous depot)
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
78
Start Date
August 14, 2019
Completion Date
October 2022
Primary Completion Date
September 2022
Eligibility 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 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%)
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Pamela Freda, M.D, +46 46 286 57 30, [email protected]
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT04076462
Organization ID
HS-18-633
Secondary IDs
2019-001191-11
Responsible Party
Sponsor
Study Sponsor
Camurus AB
Study Sponsor
Pamela Freda, M.D, Principal Investigator, Columbia University
Verification Date
June 2022