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

Camurus AB0 sites140 target enrollmentJuly 2, 2019

Overview

No summary available.

Registry

who.int

Start Date

July 2, 2019

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Main part of the trial:
•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 (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 (adjusted for age and sex; mean value of the first measurement at screening and the second measurement at 2 weeks before Day 1\)
•IGF\-1 levels \<\=1xULN at screening (adjusted for age and sex; value of the first measurement at
•screening and the second measurement at 2 weeks before Day 1\) either without prior pituitary radiotherapy or with prior pituitary radiotherapy
•Adequate liver, pancreatic, renal and bone marrow functions
•Extension Part of the Trial:

•Main part of the trial:
•For Roll\-over Patients from Trial HS\-18\-633:
•Unresolved, drug\-related serious adverse event (SAE) from the preceding trial (HS\-18\-633\)
•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 prior to screening
•Patients who have undergone pituitary surgery within 6 months prior to screening