#1 Clinical Trials Search in Europe

Masofaniten

A new clinical trial is investigating the use of Masofaniten (EPI-7386) in combination with enzalutamide for patients with metastatic castration-resistant prostate cancer (mCRPC). This phase 1/2 study aims to evaluate the safety, tolerability, and effectiveness of this combination therapy compared to enzalutamide alone in patients who have not previously received second-generation anti-androgens. The trial will assess various aspects, including dose-limiting toxicities, maximum tolerated dose, and anti-tumor activity.

Table of Contents

What is MASOFANITEN?

MASOFANITEN, also known as EPI-7386, is a new medication being studied for the treatment of metastatic castration-resistant prostate cancer (mCRPC)[1]. It is a small molecule drug that comes in the form of a film-coated tablet and is taken orally[1]. MASOFANITEN is being developed by ESSA Pharmaceutical, Inc. and is currently undergoing clinical trials to evaluate its effectiveness and safety[1].

Medical Condition: Metastatic Castration-Resistant Prostate Cancer

Metastatic castration-resistant prostate cancer (mCRPC) is an advanced form of prostate cancer that has spread to other parts of the body and no longer responds to hormone therapy (also known as androgen deprivation therapy or ADT)[1]. This condition occurs when prostate cancer cells continue to grow and spread despite low levels of testosterone in the body[1].

How MASOFANITEN Works

While the exact mechanism of action is not fully described in the provided information, MASOFANITEN is being studied in combination with another drug called enzalutamide[1]. Both medications are considered anti-androgens, which means they work by blocking the effects of male hormones (androgens) on prostate cancer cells[1]. This combination therapy aims to provide a more effective treatment for patients with mCRPC who have not previously been treated with second-generation anti-androgens[1].

Clinical Trial Details

The clinical trial for MASOFANITEN is a Phase 1/2 study that aims to evaluate the safety, tolerability, and effectiveness of EPI-7386 (MASOFANITEN) in combination with enzalutamide compared to enzalutamide alone[1]. The study is divided into two phases:

Phase 1 Objectives:

  • Determine the safety and tolerability of the combination therapy
  • Establish the maximum tolerated dose (MTD) and/or recommended Phase 2 combination dose (RP2CD)
  • Identify dose-limiting toxicities (DLTs)
  • Evaluate the pharmacokinetics (how the drug moves through the body) of both MASOFANITEN and enzalutamide when used in combination[1]

Phase 2 Objectives:

  • Evaluate the anti-tumor activity of MASOFANITEN in combination with enzalutamide compared to enzalutamide alone
  • Assess the safety of the combination therapy
  • Further study the pharmacokinetics of both drugs in combination[1]

Eligibility Criteria

To participate in this clinical trial, patients must meet specific criteria. Some key eligibility requirements include:

  • Male patients aged 18 years or older
  • Confirmed diagnosis of metastatic castration-resistant prostate cancer
  • No prior treatment with second-generation anti-androgens
  • Evidence of progressive disease despite ongoing androgen deprivation therapy
  • Adequate organ function and performance status[1]

There are also several exclusion criteria, such as certain cardiovascular conditions, brain metastases, or use of specific medications that may interfere with the study treatment[1].

Potential Benefits

While the effectiveness of MASOFANITEN is still being studied, the clinical trial aims to evaluate its potential benefits for patients with mCRPC. Some possible advantages of this treatment may include:

  • Improved anti-tumor activity compared to current treatments
  • A new option for patients who have not responded to other therapies
  • Potential for better outcomes when combined with enzalutamide[1]

Safety Considerations

As with any new medication, safety is a primary concern in the clinical trial of MASOFANITEN. The study will closely monitor patients for:

  • Side effects and adverse events
  • Changes in laboratory parameters, vital signs, and ECG readings
  • Impact on overall performance status[1]

It’s important to note that potential risks and side effects will be thoroughly evaluated throughout the clinical trial process.

In conclusion, MASOFANITEN (EPI-7386) represents a promising new treatment option for patients with metastatic castration-resistant prostate cancer. As research continues, more information about its effectiveness and safety profile will become available, potentially offering hope to those affected by this challenging form of cancer.

Aspect Details
Study Type Phase 1/2 clinical trial
Drugs Studied Masofaniten (EPI-7386) in combination with enzalutamide
Condition Metastatic castration-resistant prostate cancer (mCRPC)
Primary Objectives Evaluate safety, tolerability, and anti-tumor activity of the combination therapy
Key Inclusion Criteria Males ≥18 years, confirmed mCRPC, naïve to second-generation anti-androgens
Key Exclusion Criteria Significant cardiovascular disease, history of seizures, brain metastases
Primary Endpoint (Phase 2) Proportion of subjects with PSA decline >90% (PSA90)
Administration Oral use (film-coated tablet)

FAQ

  • What is Masofaniten (EPI-7386)? Masofaniten, also known as EPI-7386, is a new drug being studied for the treatment of metastatic castration-resistant prostate cancer. It is a small molecule that is taken orally as a film-coated tablet.
  • What is the main goal of this clinical trial? The main goal of this trial is to evaluate the safety and effectiveness of combining Masofaniten (EPI-7386) with enzalutamide compared to using enzalutamide alone in patients with metastatic castration-resistant prostate cancer who haven't received second-generation anti-androgens before.
  • Who can participate in this clinical trial? The trial is open to men aged 18 or older with confirmed metastatic castration-resistant prostate cancer. Participants must not have received second-generation anti-androgens before and must meet specific criteria regarding their cancer progression, overall health, and previous treatments.
  • What are some of the key exclusion criteria for this trial? Some key exclusion criteria include having certain cardiovascular conditions, a history of seizures, brain metastases, or using specific medications that may interfere with the study drugs. Patients who have participated in another clinical trial within 28 days of starting this study are also excluded.
  • How will the effectiveness of the treatment be measured? In Phase 2 of the study, the main measure of effectiveness will be the proportion of patients whose prostate-specific antigen (PSA) levels decrease by more than 90% (PSA90). The study will also look at other factors such as how the cancer responds to treatment and how long the treatment effects last.

Ongoing Clinical Trials on Masofaniten

  • Study of EPI-7386 and Enzalutamide for Patients with Metastatic Castration-Resistant Prostate Cancer

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Belgium France Spain

Glossary

  • Metastatic castration-resistant prostate cancer (mCRPC): A type of prostate cancer that has spread beyond the prostate to other parts of the body and continues to grow despite treatments that lower testosterone levels.
  • Enzalutamide: A medication used to treat prostate cancer by blocking the effects of androgens (male hormones) in the body.
  • Second-generation anti-androgens: Newer drugs designed to block the effects of androgens more effectively than older treatments for prostate cancer.
  • Maximum tolerated dose (MTD): The highest dose of a drug that can be given without causing unacceptable side effects.
  • Dose-limiting toxicity (DLT): Side effects that are severe enough to prevent increasing the dose of a drug in a clinical trial.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and eliminated.
  • Prostate-specific antigen (PSA): A protein produced by the prostate gland. High levels in the blood can indicate prostate cancer or other prostate conditions.
  • ECOG performance status: A scale used to assess how a patient's disease is progressing and how it affects their daily living abilities.
  • Androgen deprivation therapy (ADT): Treatment that reduces levels of male hormones (androgens) in the body to slow the growth of prostate cancer.
  • RECIST 1.1: Response Evaluation Criteria in Solid Tumors – a set of rules used to measure if tumors are responding to treatment in cancer clinical trials.

References

  1. http://clinicaltrials.eu/trial/study-of-epi-7386-and-enzalutamide-for-patients-with-metastatic-castration-resistant-prostate-cancer/