Study on the Effectiveness and Safety of CAM2029 Compared to Octreotide and Lanreotide in Patients with Gastroenteropancreatic Neuroendocrine Tumors

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What is this study about?

This clinical trial is focused on studying the effectiveness and safety of a treatment for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NET). These are rare types of tumors that occur in the pancreas and gastrointestinal tract. The study will compare a new treatment called CAM2029 (octreotide subcutaneous depot) with two existing treatments: octreotide long-acting release (LAR) and lanreotide autogel (ATG). These treatments are given as injections and are designed to help manage the symptoms and progression of the disease.

The purpose of the study is to determine if CAM2029 is more effective than the other treatments in delaying the progression of the tumors. Participants in the study will receive one of these treatments and will be monitored over time to see how their condition changes. The study will involve regular check-ups and assessments to track the health and response of the participants to the treatment.

Throughout the study, participants will receive injections of the assigned treatment and may also receive a placebo. The study will last for a period of time, during which the health and quality of life of the participants will be closely observed. The goal is to gather information that could lead to better treatment options for people with GEP-NET in the future.

1 joining the trial

Upon joining the trial, the patient will be randomly assigned to one of the treatment groups. This means that the patient will receive one of the following medications: CAM2029 (octreotide subcutaneous depot), Somatuline Autogel (lanreotide), or SANDOSTATIN LAR (octreotide long-acting release).

2 treatment administration

The patient will receive the assigned medication through an injection. CAM2029 is administered as a subcutaneous injection, which means it is injected under the skin. Somatuline Autogel is also given as a subcutaneous injection. SANDOSTATIN LAR is administered as an intramuscular injection, meaning it is injected into a muscle.

The frequency and dosage of the medication will depend on the specific treatment group to which the patient is assigned. The duration of the treatment will be determined by the trial protocol and the patient’s response to the medication.

3 monitoring and assessments

Throughout the trial, the patient’s health and response to the treatment will be closely monitored. This includes regular check-ups, blood tests, and imaging tests such as CT or MRI scans to assess the progression of the disease.

The patient’s quality of life and any side effects experienced will also be evaluated using questionnaires and other assessment tools.

4 end of trial

The trial is expected to continue until December 2026. At the end of the trial, the patient’s overall health and the effectiveness of the treatment will be reviewed.

The patient may be asked to participate in follow-up assessments to gather additional information about the long-term effects of the treatment.

Who Can Join the Study?

  • Must be a male or female who is 18 years or older.
  • Must have a confirmed diagnosis of advanced gastroenteropancreatic neuroendocrine tumors (GEP-NET) that cannot be removed by surgery or have spread to other parts of the body.
  • Must have at least one tumor that can be measured and shows a higher uptake than the liver on a special scan called a somatostatin receptor imaging. This scan should be done within 12 months before joining the study.
  • If a special scan called FDG-PET CT is done for patients with a specific type of tumor (well-differentiated Grade 3 NET), it must show that areas of the disease are also visible on the somatostatin receptor imaging.
  • Must have an ECOG performance status of 0 to 2, which means the patient is fully active or has some restrictions but can still take care of themselves.

Who Cannot Join the Study?

  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who are currently pregnant or breastfeeding.
  • Patients who have had another type of cancer in the past, unless it was treated and has not come back for at least 5 years.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have allergies to the study medications or similar drugs.
  • Patients who have had major surgery within the last 4 weeks.
  • Patients who have an active infection that requires treatment.
  • Patients who have a history of drug or alcohol abuse within the last year.
  • Patients who have a mental health condition that could affect their ability to participate in the study.
  • Patients who are unable to follow the study procedures or attend the required visits.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Medisprof S.R.L. Cluj Napoca Romania
IRCCS Humanitas Research Hospital Rozzano Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Bari Italy
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
University Hospital Maastricht Maastricht The Netherlands
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Sigmedical Services S.R.L. Suceava Romania
Netherlands Cancer Institute Amsterdam The Netherlands
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Hospital Edouard Herriot Lyon France
Hospital General Universitario Morales Meseguer Murcia Spain
Az Maria Middelares Gent Gent Belgium
MD Anderson Cancer Center Madrid Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Semmelweis University Budapest Hungary
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
IRCCS Ospedale Policlinico San Martino Genoa Italy
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Centre Hospitalier Universitaire De Nantes Nantes France
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Universita Degli Studi Di Brescia Brescia Italy
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Groupement Des Hopitaux De L’Institut Catholique De Lille Lomme France
Hospital Universitario Virgen De La Victoria Malaga Spain
Fundeni Clinical Institute Bucharest Romania
Chrsvapju Uyytkgdtjmtusm Syjwzpbjf Woluwe-Saint-Lambert Belgium
Ungpflgzjtdbmfdyrjjao Eyisj Awd Essen Germany
Rquwtnccp Zcgxorvsey Seywvcsyb Arnhem The Netherlands
Hdplmzdj Uiaoufwwllrdc Mmvnevw Dj Vyoxvfnqkn Santander Spain
Ichysyrp Cilocw Disixbmciffusfeoy L'hospitalet De Llobregat Spain
Spriydr Tdmoxjcsnpjubej Szeged Hungary
Pyjf Tjtkv Hdmgsfqf Umahlsbuaxcu Sabadell Spain
Bzowhzsgtzz Vlfsraakc Ofviiiwfnerv Kecskemet Hungary
Cwvbik Hugailmtatr Ujssslbpnqmmk Dz Dnbwn Dijon France
Ivnpsywz Rlgknqyag Poh Le Svhmik Dng Tcppwa Dujo Ajvsqku Ickp Sejhfr Meldola Italy
Ezfalek Uywllzklqxev Mfgpajm Caupfch Rmrfmctci (bzmqvol Mgu Rotterdam The Netherlands
Ckxtms Hxvadglhibw Rxezseeb Ultltfmgknkqd Dc Tglwq Tours France
Gotarhxfcoevlfkbb Vouinrdzj Pcfl Aybnhk Estydxpq Ojjcle Kmofqj Gyor Hungary
Awqfdcb Ucrhy Svdhhtctc Licqla Dq Blitvcp Bologna Italy
Uvmshwebvg Oe Amvfjlg Edegem Belgium
Fvcwiabto Pmtq Lp Iriacylsygoal Bjmfvimai Dpk Hfzsteal Ugyhxjdpgtxjb Ll Pki Madrid Spain
Hpznhfjk Vozo djubkquu Barcelona Spain
Hffiidlm Uhlwlmmvwjbku db A Cpvknv A Coruna Galicia Spain
Hhnqsaqz Uivzmdghtfpdkm Srtoufbmpf &tcuyoa Hsayrry dd Havpfzkhufj STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
22.10.2021
France France
Not recruiting
22.10.2021
Germany Germany
Not recruiting
22.10.2021
Hungary Hungary
Not recruiting
22.10.2021
Italy Italy
Not recruiting
22.10.2021
Romania Romania
Not recruiting
22.10.2021
Spain Spain
Not recruiting
22.10.2021
The Netherlands The Netherlands
Not recruiting
22.10.2021

Trial locations

Octreotide is a medication used to treat certain types of tumors in the digestive system, known as gastroenteropancreatic neuroendocrine tumors. It works by mimicking a natural hormone in the body that helps to control the growth of these tumors. In this trial, octreotide is used in two forms: a long-acting release (LAR) version, which is designed to be released slowly over time, and a subcutaneous depot version called CAM2029, which is injected under the skin and also releases the medication slowly.

Lanreotide is another medication used to treat gastroenteropancreatic neuroendocrine tumors. Like octreotide, it mimics a natural hormone in the body to help control tumor growth. In this trial, lanreotide is used in a form called autogel (ATG), which is a long-acting injection that releases the medication slowly over time to help manage the condition.

Gastroenteropancreatic Neuroendocrine Tumors – These are a group of rare tumors that originate from neuroendocrine cells in the gastrointestinal tract and pancreas. They are characterized by their ability to produce hormones, which can lead to various symptoms depending on the hormones released. The progression of these tumors can vary, with some growing slowly over many years, while others may grow more rapidly. They are often well-differentiated, meaning the tumor cells look similar to normal cells under a microscope. As the disease advances, it can spread to other parts of the body, such as the liver or lymph nodes. The course of the disease can be unpredictable, with periods of stability followed by progression.

Trial ID:
2023-508723-12-00
Protocol code:
HS-19-657
NCT ID:
NCT05050942
Trial Phase:
Therapeutic confirmatory (Phase III)

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