#1 Clinical Trials Search in Europe

Peg-7-Ethyl-10-Hydroxycamptothecin

This article discusses the ongoing clinical trials of PLX038, also known as Peg-7-Ethyl-10-Hydroxycamptothecin, a novel drug being investigated for the treatment of advanced or metastatic triple-negative breast cancer. The TOPOLOGY study, a phase II clinical trial, aims to evaluate the efficacy and safety of PLX038 in patients who have limited treatment options for this aggressive form of breast cancer.

Table of Contents

What is PLX038?

PLX038, also known as PEG-7-ETHYL-10-HYDROXYCAMPTOTHECIN or DFP-13318, is a new drug being studied for the treatment of advanced or metastatic triple-negative breast cancer[1]. It is a chemical compound that comes in the form of a solution for intravenous infusion, which means it is given directly into the bloodstream through a vein[1].

Target Condition: Advanced or Metastatic Triple-Negative Breast Cancer

Triple-negative breast cancer is a type of breast cancer that tests negative for estrogen receptors, progesterone receptors, and HER2 protein. This makes it more difficult to treat because common treatments that target these receptors are not effective. When this cancer is advanced or metastatic, it means it has spread beyond the breast to other parts of the body[1].

How PLX038 Works

While the exact mechanism of action is not fully described in the provided information, PLX038 is being studied for its potential to effectively treat triple-negative breast cancer. It belongs to a class of drugs called camptothecin derivatives, which are known to interfere with the DNA replication process in cancer cells, potentially stopping their growth and spread[1].

Clinical Trial Details

The clinical trial for PLX038, named “TOPOLOGY,” is a Phase II study designed to evaluate the efficacy and safety of the drug in patients with locally advanced or metastatic triple-negative breast cancer[1]. The main objectives of the trial include:

  • Assessing the response rate to PLX038
  • Evaluating time to response, duration of response, progression-free survival, and overall survival
  • Studying the tolerability and safety of PLX038
  • Investigating the efficacy of PLX038 in specific biomarker subgroups
  • Analyzing the pharmacokinetics and pharmacodynamics of PLX038

Eligibility Criteria

To participate in the clinical trial, patients must meet certain criteria[1]. Some key inclusion criteria are:

  • Confirmed diagnosis of locally advanced or metastatic triple-negative breast cancer
  • Have received at least two prior chemotherapy regimens for advanced or metastatic breast cancer
  • Have measurable disease according to specific criteria (RECIST version 1.1)
  • Be in generally good health with adequate organ function

There are also several exclusion criteria, such as recent major surgery, certain other medical conditions, or pregnancy[1].

Potential Benefits

The potential benefits of PLX038 are being investigated in the clinical trial. Researchers hope to see[1]:

  • Tumor response (reduction in tumor size)
  • Increased time before the cancer progresses
  • Longer overall survival
  • Effectiveness in patients with specific biomarkers

Safety and Side Effects

As with any new medication, the safety and side effects of PLX038 are being closely monitored in the clinical trial. The study will record all adverse events (side effects) and serious adverse events that occur during treatment[1]. It’s important to note that as this is an investigational drug, not all potential side effects may be known at this time.

Administration

PLX038 is administered intravenously (through a vein) in a healthcare setting. The maximum daily dose being studied is 1730 mg/m² (milligrams per square meter of body surface area), with a maximum total dose of 27680 mg/m² over a treatment period of up to 12 months[1].

Aspect Details
Drug Name PLX038 (Peg-7-Ethyl-10-Hydroxycamptothecin)
Trial Name TOPOLOGY
Trial Phase Phase II
Target Condition Advanced or metastatic triple-negative breast cancer
Primary Objective Evaluate efficacy of PLX038 on response rate
Key Secondary Objectives Assess time to response, duration of response, progression-free survival, overall survival, and safety
Administration Intravenous infusion
Key Eligibility Criteria At least two prior chemotherapy regimens, measurable disease, adequate organ function
Key Exclusion Criteria Recent major surgery, active brain metastases, certain severe illnesses

FAQ

  • What is PLX038 and how does it work? PLX038 is a new drug being tested for advanced triple-negative breast cancer. It contains a substance called Peg-7-Ethyl-10-Hydroxycamptothecin, which is designed to target and kill cancer cells. The exact mechanism is still being studied, but it's believed to interfere with cancer cell growth and survival.
  • Who is eligible to participate in the PLX038 clinical trial? The trial is for patients with locally advanced or metastatic triple-negative breast cancer who have received at least two prior chemotherapy treatments. Participants must have measurable disease and meet specific health criteria. Some patients, like those with certain brain metastases or other severe illnesses, may not be eligible.
  • What are the main goals of the TOPOLOGY study? The primary goal is to assess how well PLX038 works in shrinking tumors. Secondary goals include measuring how long the drug's effects last, how it affects survival, and evaluating its safety. The study also aims to explore potential biomarkers that might predict which patients will respond best to the treatment.
  • How is PLX038 administered to patients in the trial? PLX038 is given as an intravenous (IV) infusion. The exact dosing schedule and amount will be determined by the study protocol, but the maximum daily dose is listed as 1730 mg/m², with a maximum total dose of 27680 mg/m² over a treatment period of up to 12 months.
  • What kind of side effects might occur with PLX038? As with any new drug, the full range of side effects is not yet known. The study will carefully monitor all adverse events (AEs) and serious adverse events (SAEs) experienced by participants. These will be graded according to standardized criteria to assess their severity and potential relationship to the drug.

Ongoing Clinical Trials on Peg-7-Ethyl-10-Hydroxycamptothecin

  • Study on the Effects and Safety of PLX038 for Patients with Advanced or Metastatic Triple-Negative Breast Cancer

    Not recruiting

    2 1 1
    Investigated drugs:
    France

Glossary

  • Triple-negative breast cancer: A type of breast cancer that tests negative for estrogen receptors, progesterone receptors, and excess HER2 protein. It is typically more aggressive and has fewer treatment options than other types of breast cancer.
  • Metastatic: Cancer that has spread from its original site to other parts of the body.
  • RECIST: Response Evaluation Criteria in Solid Tumors, a set of rules used to measure how well a cancer patient responds to treatment.
  • Biomarker: A measurable indicator in the body that can predict how well a patient might respond to a particular treatment.
  • Pharmacokinetics: The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and excreted.
  • Pharmacodynamics: The study of how a drug affects the body, including its mechanism of action and the relationship between drug concentration and effect.
  • ECOG performance status: A scale used to assess how a patient's disease is progressing and how it affects daily living abilities.
  • NCI-CTCAE: National Cancer Institute Common Terminology Criteria for Adverse Events, a set of criteria for the standardized classification of adverse effects of drugs used in cancer therapy.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effects-and-safety-of-plx038-for-patients-with-advanced-or-metastatic-triple-negative-breast-cancer/