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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04125836
Recruitment Status : Recruiting
First Posted : October 14, 2019
Last Update Posted : May 6, 2023
Sponsor:
Information provided by (Responsible Party):
Camurus AB

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acromegaly Drug: CAM2029 (octreotide subcutaneous depot) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 10, 2019
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: CAM2029 (octreotide subcutaneous depot)
Octreotide subcutaneous depot for monthly injections in acromegaly patients
Other Name: CAM2029


Outcome Measures
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Primary Outcome Measures :
  1. Characterization of adverse events (AEs) [ Time Frame: Week 0-52 ]

Secondary Outcome Measures :
  1. Proportion of patients with mean IGF-1 levels ≤1xULN and ≤1.3xULN [ Time Frame: Week 50 to 52 ]
  2. Proportion of patients with mean GH levels <2.5 µg/L and <5.0 µg/L [ Time Frame: Week 50 to 52 ]
  3. 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

  4. Octreotide plasma concentrations over time [ Time Frame: Week 0-52 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ≤2.0xULN 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%)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04125836


Contacts
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Contact: Camurus AB +46462865730 medicalinfo@camurus.com

Locations
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Sponsors and Collaborators
Camurus AB
Investigators
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Principal Investigator: Diego Ferone, M.D University of Genova Endocrinology Unit
More Information
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Responsible Party: Camurus AB
ClinicalTrials.gov Identifier: NCT04125836    
Other Study ID Numbers: HS-19-647
2019-002190-66 ( EudraCT Number )
First Posted: October 14, 2019    Key Record Dates
Last Update Posted: May 6, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Camurus AB:
Acromegaly
octreotide
CAM2029
phase 3
Additional relevant MeSH terms:
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Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Octreotide
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents