CAM2029 phase 3 clinical trials
Why should I participate in a CAM2029 clinical trial?
Clinical trial HS-18-633
Clinical trial HS-18-633 (ClinicalTrials.gov Identifier: NCT04076462) is a placebo-controlled, double-blind trial in patients with acromegaly who have been receiving regular treatment with long-acting octreotide or lanreotide.
Patients are eligible for this trial if they have been on a stable dose of octreotide or lanreotide for at least 3 months and have well-controlled levels of insulin-like growth factor 1 (IGF-1).
The aim of this trial is to evaluate how effective CAM2029, a new long-acting investigational formulation of octreotide, is in controlling IGF-1 and growth hormone levels in patients with acromegaly. The trial will also evaluate the safety and tolerability of CAM2029 . This will be done by collecting information on any side effects patients may experience while receiving treatment with CAM2029.
CAM2029 will be given once monthly as an injection in the fatty tissue under the skin (subcutaneous injection). Patients in this trial will have the possibility to perform the injection themselves under supervision after being trained by trial personnel. Alternatively, the patient’s partner can also perform the injection. A total of 6 monthly doses will be given.
Other important aims of the trial are to determine how satisfied patients are when they or their partner administer CAM2029, and to collect information about Quality of Life.
In this trial, approximately two thirds of the patients will receive CAM2029 while one third will receive placebo (the same injection as CAM2029 but without the active ingredient octreotide). This will enable the two patient groups to be compared and to determine the effects of CAM2029.
The trial will last for approximately 6 months, after which all patients who have completed the trial will be offered the opportunity to participate in a follow-up trial (HS-19-647) and receive CAM2029 for another 6 months.
If a patient should experience worsening of their acromegaly during the clinical trial, it is possible for them to change to the medication (rescue therapy) they were receiving prior to participating in the trial. In this case, the patient will still remain in the trial so the data that has been collected can contribute to the results obtained to evaluate CAM2029. The patient will also be able to continue in the follow-up trial.
Clinical trial HS-19-647
Clinical trial HS-19-647 (ClinicalTrials.gov Identifier: NCT04125836) is an open-label, phase 3 trial in patients with acromegaly who either have been receiving regular treatment with octreotide or lanreotide or has received CAM2029 in clinical trial HS-18-633.
Two groups of patients are eligible for this trial.
- Group 1. Patients who have been on a stable dose of long-acting octreotide or lanreotide for at least 3 months before participating in the trial. Patients can also have been previously received radiotherapy (irradiation) treatment. Levels of insulin-like growth factor 1 (IGF-1) do not need to be well-controlled.
- Group 2. Patients who previously received treatment with CAM2029 or placebo for 6 months in clinical trial HS-18-633.
CAM2029 will be given once monthly as an injection in the fatty tissue under the skin (subcutaneous injection). Patients in this trial will have the possibility to perform the injection themselves under supervision by trial personnel and also at home for 4 of the doses after being trained. Alternatively, the patient’s partner can also perform the injection. A total of 13 monthly doses will be given.
The trial will evaluate the safety and tolerability of CAM2029, a new long-acting investigational formulation of octreotide. This will be done by collecting information on any side effects patients may experience while receiving treatment with CAM2029.
In addition to safety, the trial will also evaluate how effective CAM2029 is in controlling IGF-1 and growth hormone levels in patients with acromegaly and it effects on the patients quality of life.
In this trial, all patients will receive CAM2029. The trial will last for approximately 12 months.