EUCTR2019-002190-66-GB
Active, not recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Acromegaly
- Sponsor
- Camurus AB
- Enrollment
- 140
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
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 (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 \=1\.3xULN at screening or IGF\-1 levels \<\=1xULN at screnning with prior pituitary radiotherapy
- •Adequate liver, pancreatic, renal and bone marrow f unctions
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 124
Exclusion Criteria
- •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 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
Outcomes
Primary Outcomes
Not specified
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