A Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly

Overview

The purpose of this trial is to assess the long-term safety of CAM2029 in patients with acromegaly. Patients will be administered CAM2029 subcutaneously once monthly during 12 months. Patients fulfilling trial NCT04076462 will be offered to continue with open-label treatment week 24-52 in this trial. Anticipate approximately 70 patients enrolled from start in this trial and approximately 70 patients to roll-over from trial NCT04076462.

Full Title of Study: “A Phase 3, Open-label, Single-arm, Multi-center Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients With Acromegaly”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2021

Interventions

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

Arms, Groups and Cohorts

  • Experimental: CAM2029 (octreotide subcutaneous depot)
    • CAM2029 (octreotide subcutaneous depot) 20mg/1.0 mL for 20 mg dose, subcutaneous injection once monthly, 12 months treatment. If down-titration is required, 10mg/0.5 mL for 10 mg dose is available.

Clinical Trial Outcome Measures

Primary Measures

  • Characterization of adverse events (AEs)
    • Time Frame: Week 0-52

Secondary Measures

  • Proportion of patients with mean IGF-1 levels ≤1xULN and ≤1.3xULN
    • Time Frame: Week 50 to 52
  • Proportion of patients with mean GH levels <2.5 µg/L and <5.0 µg/L
    • Time Frame: Week 50 to 52
  • Proportion of patients/partners declared competent by a healthcare professional to administer intervention
    • Time Frame: Week 0-52
    • During patients/partners first three attempts during the trial period of 52 weeks whenever these visits take place
  • Octreotide plasma concentrations over time
    • Time Frame: Week 0-52

Participating in This Clinical Trial

Inclusion Criteria

  • 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 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 and ≤1.3xULN at screening or IGF-1 levels ≤1xULN at screening with prior pituitary radiotherapy
  • Adequate liver, pancreatic, renal and bone marrow functions
  • Normal ECG

Exclusion Criteria

For Roll-over Patients from NCT04076462:

  • Unresolved, drug-related serious adverse event (SAE) from the preceding trial
  • 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 from 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 >8.0%)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Camurus AB
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Diego Ferone, M.D, Principal Investigator, University of Genova Endocrinology Unit
  • Overall Contact(s)
    • Camurus AB, +46 46 286 57 30, info@camurus.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.