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CAM2029 for Acromegaly
Study Summary
This trial is testing the long-term safety of a drug called CAM2029 in patients with a condition called acromegaly. Patients will get the drug once a month for 12 months, and then may be able to keep getting it for another year.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I have been diagnosed with acromegaly.I have not had major surgery in the last month.I need surgery for vision problems due to pressure on my optic nerve.I have been on a stable dose of octreotide or lanreotide for at least 3 months.Your IGF-1 levels are too high or too low.I had pituitary surgery within the last 6 months.I am 18 years old or older.I've been treated for acromegaly with specific medications recently.I have ongoing serious side effects from a previous trial (NCT04076462).My liver, kidneys, pancreas, and bone marrow are working well.I have had pituitary gland radiation within the last 3 years.Your ECG results are normal.My diabetes is not well-managed (A1c > 8.0%).I take octreotide or lanreotide less often than every 4 weeks.
- Group 1: CAM2029 (octreotide subcutaneous depot)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any other ongoing or completed research studies that have used CAM2029 (octreotide subcutaneous depot)?
"CAM2029 (octreotide subcutaneous depot) was first studied in 1997 at Vanderbilt University Autonomic Dysfunction Center. Since the initial study, 105 more have been completed with 16 presently active and recruiting patients. The majority of these studies are based out of Missouri's largest city, Saint Louis."
For what purpose is CAM2029 (octreotide subcutaneous depot) most often prescribed?
"octreotide is frequently treated with CAM2029 (octreotide subcutaneous depot). Other conditions that this medication can help manage include long-term maintenance therapy, acromegaly, and metastatic carcinoid tumors."
At how many different test sites is this research being conducted?
"There are 11 sites enrolling patients for this clinical trial, which include locations such as Saint Louis, Los Angeles and Cincinnati. To reduce the burden of travel on participants, it is best to select a location closest to you."
Has CAM2029 (octreotide subcutaneous depot) received FDA approval?
"CAM2029 (octreotide subcutaneous depot) has been given a safety rating of 3. This is based on the fact that it is currently in Phase 3 clinical trials, meaning that there is both evidence of efficacy and multiple rounds data supporting its safety."
Does this experiment still need more test subjects?
"This information can be found on clinicaltrials.gov; the study is still recruiting patients and was first posted on 10/10/2019 with a most recent edit on 9/1/2022."
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