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

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Brief Title

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

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

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. Anticipate approximately 70 patients enrolled from start
      in this trial and approximately 70 patients to roll-over from trial NCT04076462.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Characterization of adverse events (AEs)

Secondary Outcome

 Proportion of patients with mean IGF-1 levels ≤1xULN and ≤1.3xULN

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, 12 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

140

Start Date

May 2020

Completion Date

September 2021

Primary Completion Date

August 2021

Eligibility 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%)
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Diego Ferone, M.D, +46 46 286 57 30, [email protected]

Location Countries

Greece

Location Countries

Greece

Administrative Informations


NCT ID

NCT04125836

Organization ID

HS-19-647

Secondary IDs

2019-002190-66

Responsible Party

Sponsor

Study Sponsor

Camurus AB


Study Sponsor

Diego Ferone, M.D, Principal Investigator, University of Genova Endocrinology Unit


Verification Date

May 2020