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A trial to assess the long-term safety of octreotide subcutaneous depot in patients with acromegaly
EU CTIS ID: 2024-510667-33-00
What this study is testing
Main part of the trail: To assess the overall safety and tolerability of CAM2029 Extension part of the trial: To assess the overall safety and tolerability of CAM2029
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Main part of the trail: Male or female patients > =18 years at screening
- Main part of the trail: Able to provide written informed consent to participate in the trial
- Main part of the trail: Diagnosis of acromegaly by historical evidence (persistent or recurrent) acromegaly
- Main part of the trail: Treatment with a stable dose of octreotide LAR or lanreotide ATG for at least 3 months as monotherapy prior to screening
- Main part of the trail: 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) or 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
- Main part of the trail: Adequate liver, pancreatic, renal and bone marrow functions
You likely can't join if
- Main part of the trail: For roll-over patients from trial HS-18-633: Unresolved, drug-related serious adverse event (SAE) from the preceding trial (HS-18-633)
- Main Exclusion Criteria for Re-invited Patients -Extension Part of the Trial: Receiving treatments (other than treatments for acromegaly) known to affect GH or IGF-1 concentration. Patients who have undergone major surgery/surgical therapy (including pituitary surgery) for any cause within 1 month prior to screening. Patients who have received pituitary irradiation since the end of the main part of the trial. Patients with poorly controlled diabetes mellitus (HbA1c >8.0%).
- Main part of the trail: For roll-over patients from trial HS-18-633: Patients with a clinically significant or unstable medical or surgical condition that may preclude safe and complete trial participation
- Main part of the trail: 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])
- Main part of the trail: For new patients: Patients who usually take octreotide LAR or lanreotide ATG less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks)
- Main part of the trail: For new patients: Patients with compression of the optic chiasm causing any visual field defect for whom surgical intervention is indicated
See the full eligibility criteria
Who can join
- Main part of the trail: Male or female patients > =18 years at screening
- Main part of the trail: Able to provide written informed consent to participate in the trial
- Main part of the trail: Diagnosis of acromegaly by historical evidence (persistent or recurrent) acromegaly
- Main part of the trail: Treatment with a stable dose of octreotide LAR or lanreotide ATG for at least 3 months as monotherapy prior to screening
- Main part of the trail: 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) or 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
- Main part of the trail: Adequate liver, pancreatic, renal and bone marrow functions
- Main part of the trail: Normal ECG
- Extension part of the trial: Continuation Criteria for Patients who Continue Directly to the Extension Part of the Trial: Patients who continue directly from the main part of the trial must complete treatment with CAM2029 in the main part of the trial, attend the Week 52 visit, and provide written informed consent to continue treatment in the extension part of the trial before treatment can be continued.
- Extension part of the trial: Main Inclusion Criteria for Re-invited Patients: Completed treatment with CAM2029 in the main part of the trial and attended the Week 52 visit. Adequate liver, pancreatic and renal functions. Normal ECG.
What rules you out
- Main part of the trail: For roll-over patients from trial HS-18-633: Unresolved, drug-related serious adverse event (SAE) from the preceding trial (HS-18-633)
- Main Exclusion Criteria for Re-invited Patients -Extension Part of the Trial: Receiving treatments (other than treatments for acromegaly) known to affect GH or IGF-1 concentration. Patients who have undergone major surgery/surgical therapy (including pituitary surgery) for any cause within 1 month prior to screening. Patients who have received pituitary irradiation since the end of the main part of the trial. Patients with poorly controlled diabetes mellitus (HbA1c >8.0%).
- Main part of the trail: For roll-over patients from trial HS-18-633: Patients with a clinically significant or unstable medical or surgical condition that may preclude safe and complete trial participation
- Main part of the trail: 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])
- Main part of the trail: For new patients: Patients who usually take octreotide LAR or lanreotide ATG less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks)
- Main part of the trail: For new patients: Patients with compression of the optic chiasm causing any visual field defect for whom surgical intervention is indicated
- Main part of the trail: For new patients: Patients who have undergone major surgery/surgical therapy for any cause within 1 month prior to screening
- Main part of the trail: For new patients: Patients who have undergone pituitary surgery within 6 months prior to screening
- Main part of the trail: For new patients: Patients who have received prior pituitary irradiation within 3 years prior to screening
- Main part of the trail: For new patients: Patients with poorly controlled diabetes mellitus (hemoglobin A1c [HbA1c] >8.0%)
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Serbia
- United States
- Turkey
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Serbia; United States; Turkey. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.