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Sodium 2-Hydroxylinoleate

This article examines the ongoing clinical trials investigating the use of Sodium 2-Hydroxylinoleate, also known as ABTL0812, in cancer treatment. These trials focus on evaluating the safety, efficacy, and potential benefits of ABTL0812 in various cancer types, including neuroblastoma, solid tumors, and metastatic pancreatic cancer. The studies aim to determine the optimal dosage, assess its effectiveness when combined with other treatments, and explore its impact on patient outcomes.

Table of Contents

What is ABTL0812?

ABTL0812 is the code name for a drug called sodium 2-hydroxylinoleate. It’s a new type of medication being developed to treat various forms of advanced cancer[1]. This drug is still in the experimental stage, which means it’s being tested in clinical trials to determine if it’s safe and effective for patients.

How Does It Work?

ABTL0812 is classified as a peroxisome proliferator-activated receptor (PPAR) alpha and gamma agonist. This means it activates certain proteins in the body that can help control cancer growth. It’s also considered an antineoplastic agent, which is a fancy term for drugs that fight cancer[2]. The exact way ABTL0812 works in the body is still being studied, but researchers believe it may help stop cancer cells from growing and spreading.

What Conditions Does It Treat?

ABTL0812 is being studied for several types of advanced cancers, including:

  • Neuroblastoma: A type of cancer that starts in early nerve cells, usually affecting children[1]
  • Other solid tumors in children: This includes various types of cancers that form solid masses in the body[1]
  • Metastatic pancreatic ductal adenocarcinoma: An advanced form of pancreatic cancer that has spread to other parts of the body[3]

It’s important to note that ABTL0812 is being tested in patients whose cancer has either come back after treatment (relapsed) or hasn’t responded well to standard treatments (refractory)[1].

Current Clinical Trials

ABTL0812 is currently being studied in several clinical trials:

  1. A phase I/II trial for children with relapsed or refractory neuroblastoma and other solid tumors[1]
  2. A phase I/II study combining ABTL0812 with a chemotherapy regimen called FOLFIRINOX for patients with metastatic pancreatic cancer[3]

These trials aim to determine the right dose of ABTL0812, assess its safety, and see how well it works in treating these cancers.

How Is It Administered?

ABTL0812 comes in the form of capsules that are taken by mouth[1]. The exact dosage and schedule depend on the specific clinical trial and the patient’s condition. In some studies, ABTL0812 is given alone, while in others, it’s combined with other cancer treatments like chemotherapy.

Potential Side Effects

As ABTL0812 is still in clinical trials, all of its potential side effects are not yet known. The trials are designed to carefully monitor patients for any adverse reactions. Common side effects of cancer treatments can include nausea, fatigue, and changes in blood cell counts, but the specific side effects of ABTL0812 will be better understood as more data is collected from the ongoing trials.

Future Prospects

While ABTL0812 shows promise, it’s important to remember that it’s still in the testing phase. The results of the current clinical trials will help determine if ABTL0812 is effective and safe enough to become an approved treatment for cancer patients. If successful, it could provide a new option for patients with hard-to-treat cancers, especially those who haven’t responded well to other treatments.

Aspect Details
Drug Name ABTL0812 (Sodium 2-Hydroxylinoleate)
Cancer Types Studied Relapsed/refractory neuroblastoma, solid tumors in children, metastatic pancreatic ductal adenocarcinoma
Administration Oral capsules
Trial Phases Phase I/II
Key Objectives Determine recommended Phase 2 dose, evaluate safety and efficacy, assess pharmacokinetics and pharmacodynamics
Combination Therapies FOLFIRINOX (for pancreatic cancer), irinotecan-temozolomide (for neuroblastoma)
Primary Endpoints Dose-limiting toxicities, progression-free survival
Secondary Endpoints Overall survival, objective response rate, quality of life, biomarker analysis
Patient Age Groups Children (1-21 years) for neuroblastoma trials, Adults (18+ years) for pancreatic cancer trial
Orphan Drug Designation Granted (EU/3/15/1485 and EU/3/17/1911)

FAQ

  • What is ABTL0812? ABTL0812 is the drug name for Sodium 2-Hydroxylinoleate, an investigational medication being studied for its potential anti-cancer properties. It is being tested in various forms of cancer, including neuroblastoma, solid tumors, and metastatic pancreatic cancer.
  • What types of cancer are being studied with ABTL0812? The clinical trials are focusing on relapsed or refractory neuroblastoma and other solid tumors in children, as well as metastatic pancreatic ductal adenocarcinoma in adults.
  • How is ABTL0812 administered? ABTL0812 is administered orally in the form of capsules. In some trials, it is given as a single agent, while in others, it is combined with chemotherapy or targeted therapies.
  • What are the main objectives of these clinical trials? The main objectives include determining the recommended Phase 2 dose (RP2D) of ABTL0812, evaluating its safety and efficacy, assessing its pharmacokinetics and pharmacodynamics, and studying its impact on progression-free survival and overall survival in cancer patients.
  • Are there any specific eligibility criteria for participating in these trials? Yes, eligibility criteria vary by trial but generally include factors such as age, cancer type and stage, previous treatments, and overall health status. Specific laboratory values and performance status scores are also considered.

Ongoing Clinical Trials on Sodium 2-Hydroxylinoleate

  • Study of ABTL0812, Irinotecan, and Temozolomide for Children with Relapsed or Refractory Neuroblastoma and Other Solid Tumors

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study of ABTL0812 with Irinotecan and Temozolomide for Children with Relapsed or Refractory Neuroblastoma and Other Solid Tumors

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on the Safety and Effectiveness of ABTL0812 with Drug Combination for Patients with Metastatic Pancreatic Cancer

    Not recruiting

    1 1 1
    Investigated drugs:
    France Spain

Glossary

  • ABTL0812: The drug name for Sodium 2-Hydroxylinoleate, an investigational anti-cancer medication being studied in clinical trials.
  • Neuroblastoma: A type of cancer that develops from immature nerve cells, most commonly occurring in children.
  • Metastatic: Cancer that has spread from its original site to other parts of the body.
  • Pancreatic ductal adenocarcinoma: The most common type of pancreatic cancer, originating in the cells lining the ducts of the pancreas.
  • FOLFIRINOX: A combination chemotherapy regimen used to treat pancreatic cancer, consisting of folinic acid, fluorouracil, irinotecan, and oxaliplatin.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives with cancer without it worsening.
  • RECIST: Response Evaluation Criteria in Solid Tumors, a set of rules used to assess how well a cancer patient responds to treatment.
  • Pharmacokinetics: The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Pharmacodynamics: The study of how a drug affects the body, including its mechanism of action and biochemical effects.
  • Dose-limiting toxicity (DLT): Side effects of a drug that are severe enough to prevent an increase in dosage or require a reduction in dosage.

References

  1. http://clinicaltrials.eu/trial/study-of-abtl0812-with-irinotecan-and-temozolomide-for-children-with-relapsed-or-refractory-neuroblastoma-and-other-solid-tumors/
  2. http://clinicaltrials.eu/trial/study-of-abtl0812-irinotecan-and-temozolomide-for-children-with-relapsed-or-refractory-neuroblastoma-and-other-solid-tumors/
  3. http://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-abtl0812-with-drug-combination-for-patients-with-metastatic-pancreatic-cancer/