A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly

• ClinicalTrials.gov Identifier: NCT04076462
• Recruitment Status: Active, not recruiting
• First Posted: September 3, 2019
• Last Update Posted: May 24, 2023
• Sponsor: Camurus AB
• Information provided by (Responsible Party): Camurus AB

Tracking Information

• First Submitted Date: August 29, 2019
• First Posted Date: September 3, 2019
• Last Update Posted Date: May 24, 2023
• Actual Study Start Date: August 14, 2019
• Estimated Primary Completion Date: May 2023 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 30, 2019): Proportion of patients with mean IGF-1 levels ≤1xULN [ Time Frame: Week 22 to 24 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 30, 2019)

• Proportion of patients with mean GH levels <2.5 µg/L [ Time Frame: Week 22 to 24 ]
• Incidence of treatment emergent adverse events and laboratory and ECG abnormalities [ Time Frame: At every visit, Week 0 to 24 ]
• Proportion of patients/partners declared competent by a healthcare professional to administer intervention [ Time Frame: 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
• Octreotide plasma concentrations over time [ Time Frame: At every visit, Week 0 to 24 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:

Double-blind

Primary Purpose: Treatment

• Condition: Acromegaly

Intervention

• Drug: CAM2029 (octreotide subcutaneous depot)
  Octreotide subcutaneous depot for monthly injections in acromegaly patients
  Other Name: CAM2029
• Drug: Matching placebo
  Matching placebo for CAM2029
  Other Name: placebo

Study Arms

• Experimental: 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.
  Intervention: Drug: CAM2029 (octreotide subcutaneous depot)
• Placebo Comparator: 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.
  Intervention: Drug: Matching placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: December 9, 2022): 72
• Original Estimated Enrollment (submitted: August 30, 2019): 78
• Estimated Study Completion Date: May 2023
• Estimated Primary Completion Date: May 2023 (Final data collection date for primary outcome measure)

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%)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany, Greece, Hungary, Italy, Poland, Russian Federation, Spain, Turkey, United Kingdom, United States

Administrative Information

• NCT Number: NCT04076462
• Other Study ID Numbers: HS-18-633; 2019-001191-11 ( EudraCT Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Camurus AB
• Original Responsible Party: Same as current
• Current Study Sponsor: Camurus AB
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Pamela Freda, M.D; Columbia University

• PRS Account: Camurus AB
• Verification Date: December 2022