#1 Clinical Trials Search in Europe

Rgx-202

A new clinical trial is exploring the potential of ompenaclid (RGX-202), a novel drug, in combination with standard treatments for patients with advanced or metastatic colorectal cancer. This study aims to evaluate the effectiveness and safety of ompenaclid when used alongside FOLFIRI (a chemotherapy regimen) and bevacizumab in patients who have previously received treatment for their cancer.

Table of Contents

What is Ompenaclid?

Ompenaclid, also known as RGX-202, is a new medication being studied for the treatment of advanced or metastatic colorectal cancer[1]. It is a small molecule inhibitor that targets a specific protein in the body called the creatine transporter, SLC6a8[1]. This means that ompenaclid works by blocking the action of this protein, which may help to slow down or stop the growth of cancer cells.

Target Condition: Advanced or Metastatic Colorectal Cancer

Ompenaclid is being developed to treat advanced or metastatic colorectal cancer that has become resistant to current treatments[1]. Colorectal cancer is a type of cancer that starts in the colon or rectum. When it’s described as “advanced” or “metastatic,” it means the cancer has spread beyond its original location to other parts of the body.

This type of cancer, especially when it’s resistant to existing treatments, is a serious health concern worldwide. Researchers are particularly interested in developing new treatments for colorectal cancers with RAS mutations, which are genetic changes that can make the cancer more aggressive and harder to treat[1].

How Ompenaclid Works

Ompenaclid is designed to work differently from existing cancer treatments. By inhibiting the creatine transporter (SLC6a8), it may interfere with the energy metabolism of cancer cells. This could potentially slow down or stop the growth of tumors, especially in cancers that have become resistant to other treatments[1].

Clinical Trial Details

A clinical trial is currently underway to test the effectiveness and safety of ompenaclid[1]. Here are some key details about the trial:

  • It’s a Phase 2 study, which means it’s testing how well the drug works and looking more closely at its side effects.
  • The study is randomized, meaning participants are randomly assigned to either receive ompenaclid or a placebo (a substance that looks like the drug but has no active ingredients).
  • It’s also double-blind, which means neither the patients nor the doctors know who is receiving ompenaclid and who is receiving the placebo. This helps ensure the results are not biased.
  • All participants will receive a combination of treatments including:
    • FOLFIRI: A combination of cancer drugs (folinic acid, fluorouracil, and irinotecan)
    • Bevacizumab: A targeted therapy that helps stop the growth of blood vessels that feed tumors
    • Either ompenaclid or a placebo

Eligibility Criteria

To participate in this study, patients must meet certain criteria[1]. Some key eligibility factors include:

  • Having advanced colorectal cancer that has spread or cannot be removed surgically
  • Having a specific genetic mutation called RAS in their cancer cells
  • Having received only one previous treatment for advanced colorectal cancer
  • Being at least 18 years old
  • Having adequate organ function and overall health status

There are also several factors that would exclude a person from participating, such as certain other medical conditions or treatments that could interfere with the study results or pose additional risks.

Potential Benefits

The main goal of this study is to see if adding ompenaclid to the standard treatment (FOLFIRI plus bevacizumab) can improve outcomes for patients with advanced colorectal cancer[1]. Researchers will be looking at several factors, including:

  • Overall response rate (ORR): How many patients see their tumors shrink or disappear
  • Progression-free survival (PFS): How long patients live without their cancer getting worse
  • Overall survival (OS): How long patients live overall
  • Duration of response (DoR): How long any improvements last
  • Disease control rate (DCR): How many patients have their disease stabilize or improve

Safety Considerations

As with any new treatment, safety is a crucial concern. The study will closely monitor patients for any side effects or adverse events[1]. This will include regular check-ups, blood tests, and other assessments to ensure patient safety throughout the trial.

It’s important to note that because ompenaclid is still in the testing phase, not all of its potential side effects may be known. Patients considering participating in this or any clinical trial should discuss the potential risks and benefits thoroughly with their healthcare provider.

Aspect Details
Study Type Randomized Phase 2 clinical trial
Main Treatment Ompenaclid (RGX-202) or placebo + FOLFIRI + Bevacizumab
Patient Population Adults with advanced or metastatic colorectal cancer, RAS mutation, previously treated
Primary Goal Compare overall response rate (ORR) between ompenaclid and placebo groups
Secondary Goals Assess progression-free survival, overall survival, duration of response, and safety
Treatment Schedule 28-day cycles, with oral ompenaclid or placebo twice daily, and FOLFIRI + bevacizumab on days 1 and 15
Follow-up Safety follow-up 30 days after last dose, extended follow-up for disease status and survival

FAQ

  • What is ompenaclid and how does it work? Ompenaclid (RGX-202) is a new drug that works as a small molecule inhibitor of the creatine transporter, SLC6a8. It is being studied to see if it can improve the effectiveness of standard treatments for advanced colorectal cancer.
  • Who is eligible for this clinical trial? The trial is for patients with advanced or metastatic colorectal cancer who have a RAS mutation and have previously received one standard treatment. Patients must be at least 18 years old and meet specific health criteria.
  • What treatments will patients receive in this study? Patients will be randomly assigned to receive either ompenaclid or a placebo, along with FOLFIRI chemotherapy and bevacizumab. FOLFIRI includes irinotecan, folinic acid, and 5-FU, while bevacizumab is a targeted therapy.
  • How long does the treatment last? The treatment is given in 28-day cycles. Patients will continue treatment until their disease progresses, they experience unacceptable side effects, or they decide to stop participating in the study.
  • What are the main goals of this clinical trial? The primary goal is to compare the overall response rate between ompenaclid and placebo groups. Secondary goals include assessing progression-free survival, overall survival, duration of response, and safety of the treatment combination.

Ongoing Clinical Trials on Rgx-202

  • Study on the Effectiveness of Ompenaclid with FOLFIRI and Bevacizumab for Patients with Advanced or Metastatic Colorectal Cancer

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Spain

Glossary

  • Metastatic colorectal cancer: Cancer that has spread from the colon or rectum to other parts of the body.
  • RAS mutation: A change in the RAS gene that can affect how cancer cells grow and respond to treatment.
  • FOLFIRI: A chemotherapy combination that includes irinotecan, folinic acid, and 5-fluorouracil (5-FU).
  • Bevacizumab: A targeted therapy drug that helps prevent the growth of blood vessels that feed tumors.
  • Ompenaclid (RGX-202): An investigational drug that inhibits the creatine transporter SLC6a8, being studied for its potential to improve cancer treatment.
  • Overall response rate (ORR): The percentage of patients whose cancer shrinks or disappears after treatment.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives without their cancer getting worse.
  • Overall survival (OS): The length of time from the start of treatment that patients are still alive.
  • Randomized study: A type of clinical trial where patients are randomly assigned to different treatment groups to compare outcomes.
  • Placebo: An inactive substance that looks like the drug being tested but has no medical effect.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-of-ompenaclid-with-folfiri-and-bevacizumab-for-patients-with-advanced-or-metastatic-colorectal-cancer/