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Pemetrexed Disodium Hemipentahydrate

This article explores the use of Pemetrexed Disodium Hemipentahydrate in clinical trials for the treatment of non-small cell lung cancer (NSCLC). Pemetrexed is being studied as part of a combination therapy with other drugs to evaluate its safety and effectiveness in patients with NSCLC. The trials aim to provide valuable insights into potential new treatment options for this challenging form of cancer.

Table of Contents

What is Pemetrexed Disodium Hemipentahydrate?

Pemetrexed Disodium Hemipentahydrate is a medication used in cancer treatment. It’s also known by its shorter name, Pemetrexed. This drug is classified as an antineoplastic agent, which means it’s designed to fight cancer cells[1]. The specific product mentioned in the clinical trial is called “Pemetrexed STADA® 25 mg/ml Konzentrat zur Herstellung einer Infusionslösung,” which translates to “Pemetrexed STADA® 25 mg/ml Concentrate for Solution for Infusion.”

What Medical Conditions Does It Treat?

Pemetrexed is primarily used to treat two types of cancer:

  • Non-small cell lung cancer (NSCLC): Specifically, it’s used for a type called non-squamous non-small cell lung cancer[1]. This is the most common form of lung cancer.
  • Malignant melanoma: This is a type of skin cancer. The clinical trial mentions its use in stage II and stage III melanoma[1].

These conditions are serious and can be life-threatening, which is why medications like Pemetrexed are crucial in their treatment.

How is Pemetrexed Administered?

Pemetrexed is given through intravenous (IV) use[1]. This means it’s administered directly into your vein. The medication comes as a concentrate that is diluted to create a solution for infusion. This method allows the drug to enter your bloodstream quickly and reach cancer cells throughout your body.

Dosage Information

The dosage of Pemetrexed can vary depending on your specific condition, body size, and how you respond to treatment. However, from the clinical trial information, we can see some general guidelines:

  • The maximum daily dose is typically 500 mg per square meter of body surface area (written as mg/m²)[1].
  • The maximum total dose over the course of treatment could be up to 17,000 mg/m²[1].
  • Treatment may last up to 24 months, depending on how you respond and any side effects you may experience[1].

It’s important to note that your doctor will determine the right dosage for you based on your individual needs and how you respond to the treatment.

Current Clinical Trials

Pemetrexed is being used in ongoing clinical trials. One such trial is studying the safety of continued treatment with a drug called GME751 (a proposed biosimilar to pembrolizumab) in patients with melanoma or non-small cell lung cancer who have previously participated in other studies[1]. In this trial, Pemetrexed is considered an “auxiliary” medication, which means it’s used alongside the main treatment being studied.

Potential Side Effects

While the clinical trial information doesn’t provide a comprehensive list of side effects, it’s important to be aware that all medications can cause side effects. In cancer treatments, these can sometimes be significant. The trial mentions monitoring for Serious Adverse Events (SAEs)[1], which are any medical occurrences that:

  • Result in death
  • Are life-threatening
  • Require hospitalization or extend an existing hospital stay
  • Result in persistent or significant disability/incapacity
  • Cause a congenital anomaly/birth defect

Always discuss potential side effects with your healthcare provider before starting any new treatment.

Aspect Details
Drug Name Pemetrexed Disodium Hemipentahydrate
Brand Name Pemetrexed STADA® 25 mg/ml
Formulation Concentrate for solution for infusion
Route of Administration Intravenous use
Maximum Daily Dose 500 mg/m²
Maximum Total Dose 17,000 mg/m²
Maximum Treatment Period 24 months
Indication Non-small cell lung cancer
Study Type Open-label, multi-center, single arm, rollover study
Primary Endpoint Safety assessment through monitoring of Serious Adverse Events (SAEs)

FAQ

  • What is Pemetrexed Disodium Hemipentahydrate? Pemetrexed Disodium Hemipentahydrate is a chemotherapy drug used in the treatment of non-small cell lung cancer. It is administered intravenously as a solution for infusion.
  • How is Pemetrexed being used in the clinical trial? In this trial, Pemetrexed is being used as part of a combination therapy with other drugs, including a proposed pembrolizumab biosimilar called GME751, for patients with non-small cell lung cancer.
  • What is the main objective of the clinical trial? The main objective of the trial is to assess the safety of continued treatment with GME751 (the proposed pembrolizumab biosimilar) by monitoring the occurrence of serious adverse events (SAEs).
  • Who is eligible to participate in this clinical trial? Eligible participants are those who have previously participated in related studies (CGME751A12101 or CGME751A12301), are at least 18 years old, and are judged to benefit from continued pembrolizumab treatment by their investigator.
  • What is the maximum treatment period for Pemetrexed in this trial? The maximum treatment period for Pemetrexed in this trial is 24 months, with a maximum total dose amount of 17,000 mg/m² (milligrams per square meter of body surface area).

Ongoing Clinical Trials on Pemetrexed Disodium Hemipentahydrate

  • Study on the Safety of Continued Treatment with GME751 (Pembrolizumab Biosimilar) for Patients with Melanoma or Non-Small Cell Lung Cancer

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Lithuania Romania Spain

Glossary

  • Pemetrexed Disodium Hemipentahydrate: A chemotherapy drug used to treat non-small cell lung cancer. It is given as an intravenous infusion and works by interfering with the growth of cancer cells.
  • Non-small cell lung cancer (NSCLC): A type of lung cancer that is the most common form of the disease. It grows and spreads more slowly than small cell lung cancer.
  • Biosimilar: A biological product that is highly similar to and has no clinically meaningful differences from an existing approved reference product.
  • Pembrolizumab: An immunotherapy drug used to treat various types of cancer, including non-small cell lung cancer. It works by helping the immune system recognize and fight cancer cells.
  • Serious Adverse Events (SAEs): Any untoward medical occurrence that results in death, is life-threatening, requires hospitalization, causes persistent or significant disability, or is otherwise considered medically important.
  • Intravenous use: A method of administering medication directly into a vein using a needle or tube.
  • mg/m²: Milligrams per square meter of body surface area, a unit used to calculate drug dosages based on a patient's size.
  • Open-label study: A type of clinical trial where both the researchers and participants know which treatment is being administered.
  • Multi-center study: A clinical trial conducted at more than one medical center or clinic.
  • Single arm study: A type of clinical trial where all participants receive the same treatment, without a control or comparison group.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-of-continued-treatment-with-gme751-pembrolizumab-biosimilar-for-patients-with-melanoma-or-non-small-cell-lung-cancer/