A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly

Brief Title

A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly

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

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.
    

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

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

Secondary Outcome

 Proportion of patients with mean GH levels <2.5 µg/L

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, six 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 Status

Drug

Estimated Enrollment

78

Start Date

August 14, 2019

Completion Date

October 2021

Primary Completion Date

September 2021

Eligibility 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%)
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Pamela Freda, M.D, +46 46 286 57 30, [email protected]

Location Countries

Germany

Location Countries

Germany

NCT ID

NCT04076462

Organization ID

HS-18-633

Secondary IDs

2019-001191-11

Responsible Party

Sponsor

Study Sponsor

Camurus AB

Study Sponsor

Pamela Freda, M.D, Principal Investigator, Columbia University

Verification Date

September 2020