Not recruitingRare disease

Study of long-term safety of octreotide subcutaneous depot (CAM2029) in patients with acromegaly

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with acromegaly, a condition where the body produces too much growth hormone, leading to abnormal growth of body tissues. The study tests a medication called CAM2029, which contains octreotide and is given as an injection under the skin. This new form of the medication is being developed to help control acromegaly symptoms over a long period.

The main purpose of this study is to evaluate how safe and well-tolerated CAM2029 is when used long-term in people with acromegaly. The medication is administered as a subcutaneous injection, which means it is given under the skin. The study consists of two parts: a main part lasting 52 weeks, followed by an extension period for additional long-term observation.

During the study, participants receive regular doses of CAM2029. The treatment can be given at doses up to 20 mg per day, with the total amount over the study period not exceeding 520 mg. Throughout the study, doctors monitor various aspects of participants' health, including how well their acromegaly symptoms are controlled and their overall well-being.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial evaluation and medication start
Your condition, acromegaly, will be evaluated through medical tests
You will start receiving CAM2029, a medication given by injection under the skin
Your liver, kidney, pancreas function and heart rhythm (ECG) will be checked
Step 2
Regular treatment phase - first 52 weeks
You will receive regular subcutaneous injections of CAM2029
Your blood will be tested to measure hormone levels (IGF-1 and GH)
You will complete questionnaires about your quality of life and satisfaction with treatment
Your health will be monitored through regular check-ups
Side effects will be recorded during each visit
Step 3
Week 52 evaluation
A thorough evaluation of your health status will be performed
Your hormone levels will be measured
Your quality of life and treatment satisfaction will be assessed
A decision about continuing to the extension phase will be made
Step 4
Extension phase
If you continue to the extension phase, you will receive ongoing CAM2029 treatment
Regular monitoring will continue with blood tests and health checks
Quality of life assessments will continue
Additional questionnaires about work productivity will be completed
Your gallbladder will be examined through imaging
Step 5
Final evaluation
A final assessment of your health status will be performed
All test results will be reviewed
The study is expected to end by May 31, 2025

Who can join the trial?

11 criteria

Age 18 years or older
Must be able to give written consent to participate in the study
Must have a confirmed diagnosis of acromegaly with historical evidence showing persistent or recurring condition
Must be currently taking a stable dose of octreotide LAR or lanreotide ATG (medications used to treat acromegaly) for at least 3 months as the only treatment
check
Must have specific IGF-1 levels (Insulin-like Growth Factor 1, a hormone that indicates acromegaly activity) that are either:
- Above normal but not more than 2 times the upper limit of normal, OR
- At or below normal limits with or without previous radiation therapy to the pituitary gland
- Must have normal liver, pancreas, kidney, and bone marrow function
- Must have a normal ECG (heart rhythm test)
- check
  For the extension part of the study:
  - Must complete the main part of the study
  - Must attend the Week 52 visit
  - Must provide new written consent for the extension phase

Who cannot join the trial?

15 criteria

History of pituitary surgery (surgery on a small gland in the brain) within 6 months before starting the study
Pituitary radiation therapy (radiation treatment targeting the pituitary gland) within the past 2 years
Known allergic reactions to medications similar to the study drug
Significant heart, liver, or kidney disease
Uncontrolled diabetes (high blood sugar levels)
Active or chronic infection, including hepatitis B, hepatitis C, or HIV
Current treatment with other medications for acromegaly
Pregnancy or breastfeeding
Participation in another clinical trial within the past 30 days
Any condition that, in the opinion of the study doctor, would make participation unsafe
Unable to follow study procedures or attend scheduled visits
History of drug or alcohol abuse within the past year
Major surgery planned during the study period
Mental health conditions that could interfere with study participation
Cancer diagnosis or treatment within the past 5 years (except for certain skin cancers)

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Verified sites

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Azienda Ospedaliera Universitaria Federico II Di Napoli
Naples, Italy
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Azienda Ospedaliera di Padova
Padua, Italy
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy

Trial locations

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Investigated drugs

CAM2029 (octreotide subcutaneous depot) is a long-acting medication used to treat acromegaly, a condition where the body produces too much growth hormone. It is administered as an injection under the skin. This medication helps control hormone levels and reduce symptoms associated with acromegaly. It is a new formulation of octreotide that allows for subcutaneous (under the skin) administration instead of the traditional deep intramuscular injection.

Octreotide Hydrochloride

What is already known about the treatment

Octreotide (CAM2029) – A subcutaneous depot formulation medication developed for the treatment of acromegaly, which is a hormonal disorder characterized by abnormal growth of body tissues. This long-acting injectable medication belongs to the class of synthetic somatostatin analogs, which work by suppressing the excessive production of growth hormone from the pituitary gland. The drug is administered through subcutaneous injection, providing a sustained release of the active substance over an extended period, which helps maintain consistent therapeutic levels in the body. Currently undergoing Phase 3 clinical trials, CAM2029 represents a potential advancement in acromegaly treatment by offering a more convenient dosing schedule compared to conventional octreotide formulations while maintaining therapeutic effectiveness.

Investigated diseases

Acromegaly - A rare hormonal disorder that develops when the pituitary gland produces too much growth hormone during adulthood. The excess growth hormone leads to gradual enlargement of body tissues, including bones of the face, jaw, hands, and feet. The condition typically develops slowly over many years, causing gradual changes in facial features, enlarged hands and feet, and widened spaces between teeth. Internal organs may also increase in size, and patients might experience joint pain, increased sweating, and fatigue. The disorder can also cause other complications such as high blood pressure, diabetes, and sleep problems.