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A Trial to Assess Efficacy and 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: NCT04076462
Recruitment Status : Recruiting
First Posted : September 3, 2019
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double-blind
Primary Purpose: Treatment
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
Actual Study Start Date : August 14, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


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

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.
Drug: Matching placebo
Matching placebo for CAM2029
Other Name: placebo




Primary Outcome Measures :
  1. Proportion of patients with mean IGF-1 levels ≤1xULN [ Time Frame: Week 22 to 24 ]

Secondary Outcome Measures :
  1. Proportion of patients with mean GH levels <2.5 µg/L [ Time Frame: Week 22 to 24 ]
  2. Incidence of treatment emergent adverse events and laboratory and ECG abnormalities [ Time Frame: At every visit, Week 0 to 24 ]
  3. 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

  4. Octreotide plasma concentrations over time [ Time Frame: At every visit, Week 0 to 24 ]


Information from the National Library of Medicine

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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 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%)

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): NCT04076462


Contacts
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Contact: Camurus AB +46 46 286 57 30 info@camurus.com

Locations
Show Show 34 study locations
Sponsors and Collaborators
Camurus AB
Investigators
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Principal Investigator: Pamela Freda, M.D Columbia University
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Responsible Party: Camurus AB
ClinicalTrials.gov Identifier: NCT04076462    
Other Study ID Numbers: HS-18-633
2019-001191-11 ( EudraCT Number )
First Posted: September 3, 2019    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: September 2020
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