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

STATUS

Recruiting
End date

Oct 20, 2023
participants needed

140
sponsor

Camurus AB

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Updated on 7 October 2022

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octreotide

pituitary

somatomedin c

lanreotide

hepatic disease

insulin-like growth factor

igf1

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.

Details

Condition	Acromegaly
Treatment	CAM2029 (octreotide subcutaneous depot)
Clinical Study Identifier	NCT04125836
Sponsor	Camurus AB
Last Modified on	7 October 2022

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Eligibility		Yes	No	Not Sure
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%)

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