Europas førende søgning efter kliniske forsøg

Arginine Hydrochloride

Clinical trials investigating Arginine Hydrochloride are studying how it is used in different research settings, mainly to assess safety and treatment effects. The trials in the source data focus on patients with neuroblastoma, gastroenteropancreatic neuroendocrine tumours, and extensive-stage small cell lung cancer, including both children and adults.

Table of contents

Overview of the clinical research

The source data includes four interventional studies that investigate Arginine Hydrochloride-related trial settings in cancer research, mainly with radiolabeled somatostatin analogs and related treatment combinations.[1][2][3][4]

These studies look at different goals, such as safety, dose finding, treatment effect, and comparison with standard care.[1][3][4]

Who the trials study

One study includes children with recurrent or refractory neuroblastoma, which means the cancer has come back or has not responded well to treatment.[1]

Another study includes adults with gastroenteropancreatic neuroendocrine tumours and focuses on people with dominant liver metastases, meaning the liver is the main place where the cancer has spread.[2]

A third study includes patients with advanced GEP-NET and compares treatment strategies in a larger group of participants.[3]

The fourth study includes people with extensive stage small cell lung cancer who are newly diagnosed and receive treatment in combination with chemotherapy and immunotherapy.[4]

Trial phases and what they mean

The data includes a Phase 1 study in children with neuroblastoma, where the main goal is to find the maximum tolerated dose.[1]

There is also a Phase 2 study in adults with GEP-NET and liver metastases, which looks at uptake on PET-scan after intra-hepatic injection and compares it with intravenous treatment.[2]

A Phase 3 study evaluates whether [177Lu]Lu-DOTA-TATE plus octreotide LAR works better than active comparator treatment in delaying progression or death.[3]

The small cell lung cancer study is listed as Phase 1 in the source data, with a first part that focuses on dose finding and safety, followed by a later part that measures survival.[4]

Main endpoints being measured

The neuroblastoma study measures the maximum tolerated dose, and its dose-limiting toxicity period lasts from the first injection until 6 weeks after the first injection.[1]

The liver metastasis study measures 68Ga-DOTA-peptides uptake on PET-scan, using the maximum standardized uptake value in up to five liver metastases.[2]

The Phase 3 GEP-NET study measures progression-free survival, defined as the time from randomization until the disease gets worse or the participant dies from any cause.[3]

The small cell lung cancer study measures the frequency of dose-limiting toxicities, adverse events, serious adverse events, events that lead to stopping treatment, and overall survival.[4]

Summary of the individual trials

  • NCT03966651 is a completed Phase 1 study in 18 children with recurrent or refractory neuroblastoma, and its main goal is to define the maximum tolerated dose.[1]
  • NCT04837885 is an authorised Phase 2 study in 23 adults with GEP-NET and dominant liver metastases, and it measures PET-scan uptake after intra-hepatic treatment.[2]
  • 2024-518325-15-00 is an authorised Phase 3 study in 241 patients with advanced GEP-NET, and it evaluates progression-free survival as the main endpoint.[3]
  • NCT05142696 is an authorised Phase 1 study in 138 newly diagnosed patients with extensive stage small cell lung cancer, and it measures safety and overall survival.[4]

Important patient terms

Interventional study means the researchers give a treatment and then observe what happens.[1][2][3][4]

Enrollment is the number of people planned or included in the study.[1][2][3][4]

Authorised means the study has been approved to proceed according to the source data.[2][3][4]

Completed means the study has finished collecting information.[1]

Radiolabeled somatostatin analogs are study drugs used in these trials to help target certain tumours, as described in the trial titles and summaries.[2][3]

Trial ID Phase Condition studied Status Enrollment
NCT03966651 Phase 1 Recurrent or refractory neuroblastoma Completed 18
NCT04837885 Phase 2 Gastroenteropancreatic neuroendocrine tumours with dominant liver metastases Authorised 23
2024-518325-15-00 Phase 3 Advanced GEP-NET Authorised 241
NCT05142696 Phase 1 Extensive stage small cell lung cancer Authorised 138

FAQ

  • What are the clinical trials with Arginine Hydrochloride trying to find out? The trials are mainly looking at safety and treatment results. They measure outcomes such as the highest tolerated dose, progression-free survival, overall survival, and how often side effects happen.
  • Who can take part in these trials? The target groups include children with recurrent or refractory neuroblastoma and adults with gastroenteropancreatic neuroendocrine tumours or extensive-stage small cell lung cancer. Each study has its own eligibility rules.
  • What trial phases are included? The source data includes Phase 1, Phase 2, and Phase 3 studies. Early-phase trials focus more on safety and dose finding, while later phases look more closely at how well the treatment works.
  • Which conditions are being studied? The studies involve recurrent or refractory neuroblastoma, gastroenteropancreatic neuroendocrine tumours, and extensive-stage small cell lung cancer. One study also focuses on patients with dominant liver metastases.
  • Are all the trials in the same stage? No. Some trials are completed and others are authorised. They also differ in size, from small studies with 18 or 23 participants to larger studies with more than 100 participants.

Igangværende kliniske forsøg for Arginine Hydrochloride

  • Et fase III-studie der undersøger effekten og sikkerheden af [177Lu]Lu-DOTA-TATE kombineret med octreotid LAR hos nydiagnosticerede patienter med grad 1 og 2 fremskreden GEP-NET

    Rekrutterer

    1 1 1 1
    Undersøgte lægemidler:
    Frankrig Tyskland Ungarn Italien Holland Polen +1

  • Behandling af kræftsvulster i mave-tarm-systemet med radioaktivt mærket hormonmedicin via leverens blodkar

    Rekrutterer

    1 1 1
    Undersøgte lægemidler:
    Frankrig

  • Studie af lutetium (177Lu) oxodotreotide, carboplatin, etoposid og atezolizumab hos nydiagnosticerede patienter med udbredt småcellet lungekræft

    Rekrutterer ikke

    1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Østrig Belgien Tjekkiet Frankrig Tyskland Italien +2

  • Test af 177Lu-DOTATATE behandling hos børn med neuroblastom kræft, der ikke reagerer på almindelig behandling

    Rekrutterer ikke

    1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Frankrig

Ordliste

  • Clinical trial: A planned research study in people that tests a treatment, a strategy, or a medical approach.
  • Phase 1: An early study phase that mainly checks safety and helps find a suitable dose.
  • Phase 2: A study phase that looks more closely at whether a treatment seems to work and continues safety checks.
  • Phase 3: A later study phase that compares a new treatment with standard care in a larger group of people.
  • Refractory: A disease that does not respond well to treatment.
  • Recurrent: A disease that has come back after treatment.
  • Progression-free survival: The length of time during and after treatment that the disease does not get worse.
  • Overall survival: The length of time from the start of a study until death from any cause.
  • Maximum tolerated dose: The highest dose that most people can take without unacceptable side effects.
  • Dose-limiting toxicities: Side effects that are severe enough to limit how much treatment can be given.
  • PET-scan: A scan that helps show how active a tumour is in the body.
  • Randomization: A method where participants are placed into study groups by chance.

Referencer

  1. https://kliniske-forsoeg.dk/forsog/test-af-177lu-dotatate-behandling-hos-born-med-neuroblastom-kraeft-der-ikke-reagerer-pa-almindelig-behandling/
  2. https://kliniske-forsoeg.dk/forsog/behandling-af-kraeftsvulster-i-mave-tarm-systemet-med-radioaktivt-maerket-hormonmedicin-via-leverens-blodkar/
  3. https://clinicaltrials.gov/study/2024-518325-15-00
  4. https://kliniske-forsoeg.dk/forsog/undersogelse-af-luteum-177lu-oxodotreotide-sammen-med-en-laegemiddelkombination-til-patienter-med-nydiagnosticeret-udbredt-smacellet-lungekraeft/