#1 Clinical Trials Search in Europe

Vosilasarm

Vosilasarm, also known as EP0062 or RAD-140, is a new drug being studied in clinical trials for patients with advanced or metastatic breast cancer. This article explores the ongoing research on Vosilasarm, its potential benefits, and what patients should know about participating in these trials.

Table of Contents

What is VOSILASARM?

VOSILASARM, also known as EP0062 or RAD-140, is a new medication being studied for the treatment of advanced breast cancer[1]. It belongs to a class of drugs called selective androgen receptor modulators (SARMs), which are designed to target specific tissues in the body, particularly those affected by breast cancer[1].

How Does VOSILASARM Work?

VOSILASARM works by interacting with androgen receptors (AR) in the body. Androgen receptors are proteins that play a role in the development and progression of certain types of breast cancer. By targeting these receptors, VOSILASARM may help to slow down or stop the growth of cancer cells[1].

What Conditions Does VOSILASARM Treat?

VOSILASARM is being studied for the treatment of a specific type of breast cancer known as AR+/HER2-/ER+ breast cancer. This means the cancer is:[1]

  • AR+ (Androgen Receptor positive): The cancer cells have androgen receptors on their surface.
  • HER2- (Human Epidermal Growth Factor Receptor 2 negative): The cancer cells do not have high levels of a protein called HER2.
  • ER+ (Estrogen Receptor positive): The cancer cells have estrogen receptors on their surface.

Specifically, the clinical trial is focusing on patients with relapsed locally advanced or metastatic breast cancer. This means the cancer has either come back after previous treatment and spread to nearby areas (locally advanced), or it has spread to other parts of the body (metastatic)[1].

Clinical Trial Information

VOSILASARM is currently being studied in a clinical trial. This trial is a Phase 1/2 study, which means it’s designed to test the safety, effectiveness, and optimal dosage of the drug[1]. The study is divided into two main parts:

  1. Module A: This part of the study aims to:
    • Evaluate the safety and tolerability of VOSILASARM
    • Determine the best dose of VOSILASARM when given alone
    • Study how the drug is processed in the body (pharmacokinetics)
    • Look at early signs of effectiveness
  2. Module B: This part of the study will:
    • Test VOSILASARM in combination with other cancer treatments
    • Continue to evaluate safety and effectiveness

Who Can Participate in the Trial?

The trial has specific criteria for who can participate. Some key points include[1]:

  • Women aged 18 or older
  • Diagnosed with AR+/HER2-/ER+ breast cancer that has spread locally or to other parts of the body
  • Cancer that has returned after previous treatments
  • Postmenopausal status
  • Previous treatment with certain types of cancer therapies

There are also several factors that might prevent someone from participating in the trial, such as certain medical conditions or previous treatments[1].

Potential Benefits and Risks

As with any experimental treatment, there are potential benefits and risks to participating in this clinical trial:

Potential Benefits:

  • Access to a new treatment that may be effective against advanced breast cancer
  • Close monitoring by healthcare professionals
  • Contributing to medical research that could help future patients

Potential Risks:

  • Unknown side effects or complications
  • The treatment may not be effective for everyone
  • Time commitment for study visits and procedures

Conclusion

VOSILASARM represents a promising new approach in the treatment of advanced AR+/HER2-/ER+ breast cancer. While it’s still in the clinical trial phase, this medication could potentially offer new hope for patients who have not responded to other treatments. As always, patients should discuss their options with their healthcare provider to determine if participating in a clinical trial might be right for them[1].

Aspect Details
Drug Name Vosilasarm (EP0062, RAD-140)
Drug Type Oral selective androgen receptor modulator (SARM)
Target Condition Advanced or metastatic AR+/HER2-/ER+ breast cancer
Trial Phase Phase 1/2
Main Objectives Evaluate safety, tolerability, pharmacokinetics, and efficacy
Key Eligibility Criteria Women 18+, specific breast cancer type, prior treatments
Primary Endpoints Dose-limiting toxicities, adverse events, optimal dosage
Secondary Endpoints Pharmacokinetics, objective response rate, survival measures

FAQ

  • What is Vosilasarm and how does it work? Vosilasarm (EP0062) is an oral selective androgen receptor modulator (SARM) being studied for treating advanced breast cancer. It works by targeting androgen receptors in breast cancer cells, potentially slowing or stopping cancer growth.
  • Who is eligible for the Vosilasarm clinical trials? The trials are mainly for women aged 18 or older with advanced or metastatic breast cancer that is androgen receptor-positive (AR+), HER2-negative, and estrogen receptor-positive (ER+). Participants must have received prior treatments and meet specific health criteria.
  • What are the main goals of the Vosilasarm clinical trials? The trials aim to evaluate the safety, tolerability, and effectiveness of Vosilasarm alone and in combination with other treatments. They also seek to determine the optimal dosage and study how the drug behaves in the body.
  • What are some potential side effects of Vosilasarm? While specific side effects are still being studied, the trials closely monitor for any adverse events. Common side effects of cancer treatments may include fatigue, nausea, and changes in blood cell counts. The study team will provide detailed information about potential risks.
  • How long do the Vosilasarm clinical trials last? The duration of the trials can vary, but they typically involve multiple cycles of treatment. Participants are monitored closely throughout the study, which may last several months or longer, depending on how well they respond to the treatment.

Ongoing Clinical Trials on Vosilasarm

  • Study on the Safety and Effects of Vosilasarm Alone and in Combination for Patients with Relapsed Advanced or Metastatic Breast Cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • Androgen receptor (AR): A protein in cells that testosterone and other male hormones attach to. In some breast cancers, these receptors may play a role in cancer growth.
  • HER2-negative: Breast cancer cells that do not have a high amount of a protein called HER2 on their surface. This affects which treatments may work best.
  • Estrogen receptor-positive (ER+): Breast cancer cells that have a protein (receptor) that binds to the hormone estrogen. These cancers may grow in response to estrogen.
  • Metastatic: Cancer that has spread from where it started to other parts of the body.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and eliminated.
  • Dose-limiting toxicity (DLT): Side effects of a drug that are severe enough to prevent an increase in dosage or require a decrease in dosage.
  • Objective 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 with cancer without it getting worse.
  • Clinical benefit rate (CBR): The percentage of patients with advanced or metastatic cancer who have a complete response, partial response, or stable disease for a minimum time period.
  • Overall survival (OS): The length of time from the start of treatment that patients are still alive.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-effects-of-vosilasarm-alone-and-in-combination-for-patients-with-relapsed-advanced-or-metastatic-breast-cancer/