#1 Clinical Trials Search in Europe

Octreotide Hydrochloride

Octreotide Hydrochloride, a medication used in the form of a subcutaneous depot injection called CAM2029, is currently being studied in clinical trials for various medical conditions. These trials aim to assess the safety and effectiveness of CAM2029 in treating polycystic liver disease, gastroenteropancreatic neuroendocrine tumors, and acromegaly. The studies explore different aspects of the drug’s performance, including its ability to reduce liver volume, slow tumor progression, and manage hormone levels in patients with these conditions.

Table of Contents

What is Octreotide Hydrochloride?

Octreotide Hydrochloride, also known as CAM2029 or octreotide subcutaneous depot, is a medication used to treat various medical conditions[1]. It belongs to a class of drugs called somatostatin analogs, which are synthetic versions of a naturally occurring hormone in the body[2].

Medical Conditions Treated

Octreotide Hydrochloride is used to treat several medical conditions, including:

  • Polycystic Liver Disease (PLD): A condition where multiple cysts develop in the liver[1].
  • Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET): A type of cancer that affects the digestive system and pancreas[2].
  • Acromegaly: A hormonal disorder that results from excess growth hormone production[3].

How It Works

Octreotide Hydrochloride works by mimicking the effects of somatostatin, a natural hormone in the body. It helps to:

  • Reduce the production of certain hormones, including growth hormone and insulin-like growth factor 1 (IGF-1)[3].
  • Slow down the growth of tumors in conditions like GEP-NET[2].
  • Potentially reduce the size and symptoms of liver cysts in PLD[1].

Administration

Octreotide Hydrochloride is administered as a subcutaneous injection, which means it’s injected under the skin[1][2][3]. The medication is designed as a long-acting depot formulation, which allows for less frequent dosing compared to other forms of octreotide.

In some cases, patients or their partners may be trained to administer the medication at home[3]. This can provide more convenience and flexibility in treatment.

Efficacy

The effectiveness of Octreotide Hydrochloride varies depending on the condition being treated:

  • For PLD, it may help reduce liver volume and improve symptoms related to the disease[1].
  • In GEP-NET, it aims to slow tumor growth and improve progression-free survival[2].
  • For acromegaly, it helps control hormone levels, particularly IGF-1 and growth hormone[3].

Side Effects and Safety

As with any medication, Octreotide Hydrochloride can cause side effects. Common side effects may include:

  • Injection site reactions
  • Gastrointestinal symptoms (e.g., nausea, diarrhea)
  • Changes in blood sugar levels
  • Gallbladder-related issues

It’s important to discuss potential side effects and safety concerns with your healthcare provider[1][2][3].

Ongoing Research

Several clinical trials are currently underway to further evaluate the efficacy and safety of Octreotide Hydrochloride in various conditions:

  • A study is assessing its use in symptomatic polycystic liver disease[1].
  • Another trial is comparing it to existing treatments for gastroenteropancreatic neuroendocrine tumors[2].
  • A long-term safety study is being conducted for patients with acromegaly[3].

These ongoing studies aim to provide more information about the medication’s effectiveness, optimal dosing, and long-term safety profile.

Aspect Details
Drug Name Octreotide Hydrochloride (CAM2029)
Administration Method Subcutaneous depot injection
Conditions Studied Polycystic Liver Disease, Gastroenteropancreatic Neuroendocrine Tumors, Acromegaly
Main Objectives Assess safety and efficacy in reducing liver volume, slowing tumor progression, managing hormone levels
Key Measurements Liver volume, tumor progression, hormone levels (IGF-1, GH), quality of life, adverse events
Trial Durations Varying from several months to over 2 years
Unique Features Self-administration possibility, long-acting formulation, comparison with existing treatments

FAQ

  • What is Octreotide Hydrochloride and how is it administered in these clinical trials? Octreotide Hydrochloride is the active ingredient in CAM2029, a medication administered as a subcutaneous depot injection. In the clinical trials, it is being tested as a long-acting formulation that can be self-administered or given by a healthcare professional.
  • What medical conditions are being studied in these Octreotide Hydrochloride clinical trials? The clinical trials are studying the use of Octreotide Hydrochloride (CAM2029) in treating polycystic liver disease, gastroenteropancreatic neuroendocrine tumors (GEP-NET), and acromegaly.
  • What are the main goals of these clinical trials? The main goals of these trials include assessing the safety and effectiveness of CAM2029 in reducing liver volume in polycystic liver disease, evaluating its ability to slow disease progression in GEP-NET, and determining its long-term safety and efficacy in managing acromegaly symptoms.
  • How long do these clinical trials typically last? The duration of these trials varies, but they can last from several months to over two years. For example, the acromegaly trial includes a main part and an extension part, potentially lasting up to 104 weeks (2 years).
  • What are some of the key measurements being taken in these trials? Key measurements include changes in liver volume, tumor progression, hormone levels (such as IGF-1 and GH in acromegaly), quality of life assessments, and safety evaluations including adverse events, laboratory values, and ECG readings.

Ongoing Clinical Trials on Octreotide Hydrochloride

  • Study of long-term safety of octreotide subcutaneous depot (CAM2029) in patients with acromegaly

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Hungary Italy Poland Spain

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

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Hungary Italy The Netherlands +2

  • Study on Octreotide for Patients with Symptomatic Polycystic Liver Disease

    Not recruiting

    4 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Germany The Netherlands

Glossary

  • Polycystic Liver Disease (PLD): A condition where multiple cysts develop throughout the liver, potentially causing the liver to enlarge and affect its function.
  • Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET): Rare tumors that form in the digestive system, including the pancreas, and can produce excess hormones.
  • Acromegaly: A hormonal disorder that results from too much growth hormone (GH) in the body, typically causing enlarged hands, feet, and facial features.
  • Subcutaneous Depot: A method of drug administration where the medication is injected under the skin and slowly released over time.
  • IGF-1 (Insulin-like Growth Factor 1): A hormone similar to insulin that plays an important role in growth and is often elevated in acromegaly.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with the disease but it does not get worse.
  • RECIST 1.1: Response Evaluation Criteria in Solid Tumors, a set of rules used to assess how well a cancer patient responds to treatment.
  • Quality of Life (QoL): A measure of an individual's well-being and ability to perform daily activities, often assessed in clinical trials to determine the impact of treatment on patients' lives.
  • Adverse Events (AEs): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.

References

  1. http://clinicaltrials.eu/trial/study-on-octreotide-for-patients-with-symptomatic-polycystic-liver-disease/
  2. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-cam2029-compared-to-octreotide-and-lanreotide-in-patients-with-gastroenteropancreatic-neuroendocrine-tumors/
  3. http://clinicaltrials.eu/trial/study-on-the-long-term-safety-of-octreotide-hydrochloride-for-patients-with-acromegaly/