#1 Clinical Trials Search in Europe

Study on the Safety of Lanreotide and Metformin for Patients with Advanced Gastrointestinal or Lung Carcinoids

2 1 1 1

What is this study about?

This clinical trial is focused on studying the safety of a treatment combination for patients with advanced forms of certain types of tumors known as gastrointestinal or lung carcinoids. These are rare types of tumors that develop in the digestive system or lungs. The treatment being tested includes two medications: Lanreotide, which is given as an injection, and Metformin, which is taken as a tablet. Lanreotide is a type of medication that helps to control the growth of certain tumors, while Metformin is commonly used to manage blood sugar levels in people with diabetes.

The purpose of this study is to evaluate how safe it is to use Lanreotide in combination with Metformin in patients with these specific types of tumors. Participants in the study will receive both medications and will be monitored for any side effects or changes in their condition. The study is designed to observe how the body responds to this combination of treatments over a period of time. Participants will receive regular check-ups, including physical exams and laboratory tests, to ensure their safety and to gather information about the treatment’s effects.

This study is open-label, meaning that both the participants and the researchers know which treatments are being administered. It is a pilot study, which means it is an initial, smaller-scale study to gather preliminary data. The study will help researchers understand the potential benefits and risks of using Lanreotide and Metformin together in treating advanced gastrointestinal or lung carcinoids. The information gathered from this study may contribute to future research and treatment options for these types of tumors.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.

Blood tests are performed to check various health indicators such as neutrophil counts, platelet counts, hemoglobin levels, and liver function tests.

A physical examination is conducted to assess overall health and any specific symptoms related to the condition being studied.

2 treatment initiation

The treatment phase begins with the administration of lanreotide and metformin.

Lanreotide is given as an intramuscular injection at a dose of 120 mg. This is a solution for injection provided in a pre-filled syringe.

Metformin is taken orally in the form of film-coated tablets, with a dosage of 850 mg per tablet.

3 ongoing treatment and monitoring

The treatment continues with regular administration of the medications as prescribed.

Regular monitoring is conducted to evaluate the safety and effectiveness of the treatment. This includes physical examinations, laboratory tests, and cardiologic assessments.

The study aims to assess any adverse effects (AEs) or serious adverse effects (SAEs) that may occur during the treatment period.

4 evaluation of treatment efficacy

The efficacy of the treatment is evaluated by measuring the time to progression (TTP) of the disease. This is defined as the time from the first administration of the study drugs to the first sign of disease progression or tumor-related death.

The study also evaluates the symptomatic response to the treatment, assessing any changes in symptoms experienced by the patient.

5 completion of study participation

Upon completion of the study period, a final assessment is conducted to evaluate the overall health status and any long-term effects of the treatment.

Patients are advised on any necessary follow-up care or monitoring after the study concludes.

Who Can Join the Study?

  • Adult patients, both male and female, who are older than 18 years.
  • Blood tests must show:
    • Neutrophils (a type of white blood cell) count greater than 1.5 x 103 per liter.
    • Platelet count greater than 100 x 103 per liter.
    • Hemoglobin (a protein in red blood cells) greater than 9 grams per deciliter.
    • Total Bilirubin (a substance made by the liver) less than 1.5 times the normal upper limit.
    • AST and ALT (liver enzymes) less than 2.5 times the normal upper limit.
    • Alkaline phosphatase (an enzyme related to the liver) less than 2.5 times the normal upper limit.
    • Serum creatinine (a waste product in the blood) less than 1.5 milligrams per deciliter.
    • CCr (creatinine clearance, a measure of kidney function) equal to or greater than 60 milliliters per minute.
  • ECOG performance status of 2 or less, which is a scale to assess how a patient’s disease is progressing and how the disease affects their daily living abilities.
  • Life expectancy of more than 12 months.
  • Must provide written informed consent to participate in the study.
  • Female participants who can have children must use a medically accepted method of birth control and agree to continue using it during the study and for at least 60 days after the study. Acceptable methods include:
    • Double barrier method (e.g., condom and diaphragm).
    • Spermicide.
    • Intrauterine device (IUD).
    • Steroidal contraceptive (e.g., oral, transdermal, implanted, injected) with a barrier method.
  • Male participants with female partners who can have children must use a medically accepted method of birth control and agree to continue using it during the study and for 60 days after the study.
  • Patients with advanced disease that cannot be surgically removed, as evaluated by a specialized medical team.
  • Patients with a confirmed diagnosis of advanced well-differentiated (G1 and G2) gastrointestinal or lung carcinoids, according to the latest WHO Classification criteria for neuroendocrine tumors (NET).
  • Tumor tissue must be available for analysis.
  • Measurable disease and disease progression within 6 months before joining the study, confirmed by appropriate imaging tests.
  • Patients who have previously received treatment with surgery, chemotherapy, somatostatin analogues, m-TOR inhibitors, or other systemic cancer therapies.
  • Patients with functioning or non-functioning NETs.
  • Patients with type-2 diabetes or normal blood sugar levels.
  • Documented uptake of Octreoscan/PET Ga or IHC stain of SSTR2 receptor within 6 months before joining the study.

Who Cannot Join the Study?

  • Patients with advanced progressive gastro-intestinal or lung carcinoids cannot participate. These are types of tumors that grow in the digestive system or lungs and are getting worse over time.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy

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

Trial status

Country Status Recruitment Start
Italy Italy
Recruiting
12.05.2016

Trial locations

Investigated drugs:

Lanreotide is a medication used in this trial to help manage symptoms and slow the growth of certain types of tumors, specifically well-differentiated gastro-intestinal or lung carcinoids. It works by mimicking a natural hormone in the body that can inhibit the release of other hormones and growth factors that may contribute to tumor growth.

Metformin is a medication commonly used to manage blood sugar levels in people with type 2 diabetes. In this trial, it is being used in combination with Lanreotide to explore its potential benefits in treating patients with advanced carcinoid tumors. Metformin may have effects on tumor growth and metabolism, which is why it is being studied in this context.

Investigated diseases:

Gastrointestinal Carcinoid Tumors – These are a type of neuroendocrine tumor that typically develops in the digestive tract, including the stomach, intestines, and rectum. They grow slowly and may not cause symptoms initially, but as they progress, they can lead to abdominal pain, diarrhea, and flushing. Over time, these tumors can spread to other parts of the body, such as the liver, causing more severe symptoms. The progression of the disease can vary, with some tumors remaining stable for years while others grow more rapidly.

Lung Carcinoid Tumors – These are rare, slow-growing tumors that originate in the lungs and are a type of neuroendocrine tumor. They often do not cause symptoms in the early stages, but as they grow, they can lead to coughing, wheezing, and shortness of breath. In some cases, they may produce hormones that cause symptoms like flushing or diarrhea. The progression of lung carcinoid tumors can vary, with some remaining localized while others may spread to lymph nodes or other organs.

Trial ID:
2024-513200-34-00
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • A Study of MK-1084 and Drug Combination Versus Pembrolizumab and Chemotherapy for Adults with Advanced Lung Cancer with KRAS G12C Mutation

    Recruiting

    3 1 1 1
    Investigated drugs:
    Austria Belgium France Germany Greece Hungary +5

  • A study to evaluate the effectiveness of tarlatamab in patients with extensive-stage small cell lung cancer that has progressed after prior treatment and who have limited health status

    Recruiting

    2 1 1
    Investigated drugs:
    France Greece Italy Spain