Active not recruitingPHASE3INTERVENTIONAL

A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET

This research is looking into a new treatment called CAM2029 for people with a type of cancer known as gastro-enteropancreatic neuroendocrine tumour (GEP-NET). This is a cancer that affects the gut or pancreas. The main goal is to see how well CAM2029 works and how safe it is, compared to two other medicines already used for GEP-NET, called octreotide LAR and lanreotide ATG. The study is for patients with advanced GEP-NET, meaning it has spread or can't be removed by surgery. If the cancer starts to grow again during the first part of the study, patients might be able to receive an increased dose of CAM2029 in a later part of the study. This helps researchers understand the new medicine better.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Camurus AB

Enrolment target

332

Start

22 Oct 2021

Estimated completion

01 Jul 2028

Gastro-enteropancreatic Neuroendocrine Tumor

What is this study about?

This study is a clinical trial, which means it's a carefully planned research study to find out more about a new medicine. In this trial, researchers are investigating a drug called CAM2029. They want to see if it's a good and safe option for people who have a condition called gastro-enteropancreatic neuroendocrine tumour (GEP-NET). This type of cancer usually starts in the gut or pancreas and can sometimes spread to other parts of the body.

The main purpose of this study is to compare CAM2029 with treatments that are already available, specifically octreotide LAR and lanreotide ATG. The researchers are looking at two key things: how effective CAM2029 is at treating the cancer, and how safe it is for patients to take. They are particularly interested in patients whose GEP-NET is advanced, meaning it has spread or can't be removed by surgery, and is considered 'well-differentiated', which describes how the cancer cells look under a microscope.

If a patient's cancer gets worse during the first part of the study, they might have the option to continue in a second part. In this second part, they would receive a higher or more frequent dose of CAM2029. This helps the researchers gather more information about how different doses of the new medicine might work. Overall, this study aims to find better ways to treat GEP-NET and improve the lives of people living with this condition.

Key takeaways

This study is testing a new drug for advanced GEP-NET.
It compares the new drug (CAM2029) to current standard treatments.
Participation involves regular clinic visits, injections, and scans.
You might get the new drug or an existing one, assigned randomly.
There's an option for intensified treatment if the cancer progresses.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a confirmed diagnosis of advanced GEP-NET that has either spread or can't be surgically removed. Your cancer should also be 'well-differentiated', which means the cells look more like normal cells. Importantly, scans like an MRI or CT scan must show that there's at least one part of the cancer that can be measured, and that it reacts to a specific type of scan called a somatostatin receptor scan. You also need to be generally well enough to take part, with an ECOG performance status of 0 to 2, which your doctor can explain.

There are also reasons why you might not be able to join. For instance, if your cancer has recently gotten worse while you were on other treatments, including similar medicines. You also can't have known cancer in your brain or spinal cord. If you've been taking long-acting medicines similar to those being studied for more than six months in a row, or if your hormone-related symptoms from the cancer can't be controlled with standard doses of existing treatments, you might not be suitable.

Other reasons include if you've had certain types of cancer treatment recently, such as more than one round of certain targeted therapies or chemotherapy, or certain procedures to block blood flow to the tumour within the last year. Also, if you've ever had a specific type of radiation treatment called radioligand therapy, you won't be able to join. Your study doctor will carefully go through all these details with you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have advanced GEP-NET that has spread or can't be removed by surgery?
Do scanning results show at least one measurable tumour spot that is somatostatin receptor-positive?
Have you not had recent progression on similar treatments?
Do you not have cancer that has spread to your brain or spinal cord?
Have you not received radioligand therapy before?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to receive either the new medicine, CAM2029, or one of the existing treatments (octreotide LAR or lanreotide ATG). This means you wouldn't get to choose which medicine you receive, similar to flipping a coin. You would receive the study medication as injections. You'll have regular visits to the clinic for assessments, which will include blood tests, physical examinations, and imaging scans (like CT or MRI) to check how the treatment is working and monitor your health. These visits will continue throughout the study. The total duration of your participation in the study will depend on how your cancer responds to the treatment and for how long you can safely continue. If your cancer grows during the first part of the study, you might have the option to continue with higher doses of CAM2029.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as gaining access to a new treatment like CAM2029 before it's widely available, which might be more effective for your condition. You'll also receive close medical attention and monitoring from a dedicated team. However, there are potential risks, too. The new medicine might have side effects that are not yet fully known, or it might not work as well as expected. There's also the chance that you could receive an existing treatment rather than the new one. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (98)

Mayo Clinic Cancer Center (MCCC) - Phoenix
Verified postcode
Phoenix, United States
UCLA Ahmanson Biological Imaging Center
Verified postcode
Santa Monica, United States
Rocky Mountain Cancer Centers - Denver - Midtown
Verified postcode
Denver, United States
Mayo Clinic Hospital - Florida
Verified postcode
Jacksonville, United States
Anderson Family Cancer Institute
Verified postcode
Jupiter, United States
University of Kentucky (UK) - Markey Cancer Center
Verified postcode
Lexington, United States
East Jefferson General Hospital
Verified postcode
Metairie, United States
Dana-Farber Cancer Institute
Verified postcode
Boston, United States
Mayo Clinic Rochester
Verified postcode
Rochester, United States
Memorial Sloan-Kettering Cancer Center
Verified postcode
New York, United States
The Mount Sinai Hospital
Verified postcode
The Bronx, United States
White Plains Hospital - Center for Cancer Care
Verified postcode
White Plains, United States

Common questions

What is GEP-NET?

GEP-NET stands for gastro-enteropancreatic neuroendocrine tumour. It's a type of cancer that can develop in the cells of your gut or pancreas.

What does 'advanced' cancer mean in this study?

In this study, 'advanced' means the cancer has spread from where it started (metastatic) or cannot be removed by surgery (unresectable).

Will I know which treatment I'm getting?

In the first part of the study, you will be randomly assigned to receive either CAM2029 or one of the existing treatments, and you might not know which one you are taking until later.

What if my cancer gets worse during the study?

If your cancer starts to grow during the first part of the study, you might have the option to join another part where you would receive increased doses of CAM2029.

What is a 'Phase 3' study?

A Phase 3 study is a large study that compares a new treatment to existing ones to see if it's better and safer before it can be approved for general use.