A Study to Assess Effectiveness and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly

Overview

About this study

The purpose of this study is to assess the effectiveness and safety of CAM2029 in patients with acromegaly. Patients will be randomized to either CAM2029 or placebo administered subcutaneously once monthly during 6 months.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: 

  • Male or female patients.
  • Age ≥ 18 years old 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 ≤ 1 x ULN 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%)

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Irina Bancos, M.D.

Open for enrollment

Contact information:

Melinda Thomas B.S.

(507)293-6628

Thomas.Melinda@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20472288

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