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(6S,9As)-8-((6-(3-(4-Ethyl-1-Piperazinyl)-1-Azetidinyl)-2-Pyridinyl)Methyl)-6-((2-Fluoro-4-Hydroxyphenyl)Methyl)Hexahydro-4,7-Dioxo-N-(Phenylmethyl)-2-(2-Propen-1-Yl)-2H-Pyrazino(2,1-C)(1,2,4)Triazine-1(6H)-Carboxamide

E7386 is an innovative drug currently being studied in clinical trials for the treatment of various solid tumors, including colorectal cancer, hepatocellular carcinoma, and endometrial cancer. These trials aim to assess the safety, tolerability, and efficacy of E7386 when used alone or in combination with other anticancer drugs. The studies focus on patients who have previously received treatment for their cancer and are looking for new therapeutic options.

Table of Contents

What is E7386?

E7386 is an investigational drug being developed by Eisai Ltd. for the treatment of various solid tumors[1]. It is a new type of medication that is taken orally as a tablet[1]. The full chemical name of E7386 is quite complex: (6S,9AS)-8-((6-(3-(4-ETHYL-1-PIPERAZINYL)-1-AZETIDINYL)-2-PYRIDINYL)METHYL)-6-((2-FLUORO-4-HYDROXYPHENYL)METHYL)HEXAHYDRO-4,7-DIOXO-N-(PHENYLMETHYL)-2-(2-PROPEN-1-YL)-2H-PYRAZINO(2,1-C)(1,2,4)TRIAZINE-1(6H)-CARBOXAMIDE[1]. For simplicity, researchers refer to it as E7386.

How Does E7386 Work?

E7386 is believed to work by modulating the immune system within the tumor environment[2]. While the exact mechanism is still being studied, researchers think it may help activate the body’s immune response against cancer cells. This type of treatment that harnesses the power of the immune system is known as immunotherapy.

What Conditions Does E7386 Treat?

E7386 is being investigated for the treatment of several types of solid tumors, including:

  • Colorectal cancer (cancer of the colon or rectum)[1]
  • Hepatocellular carcinoma (the most common type of liver cancer)[1]
  • Melanoma (a type of skin cancer)[1]
  • Endometrial cancer (cancer of the lining of the uterus)[2]
  • Other solid tumors[2]

It’s important to note that E7386 is still in the experimental stage and is not yet approved for general use. It is being studied in patients who have already tried other treatments that didn’t work or stopped working[1][2].

Clinical Trials

E7386 is currently being studied in clinical trials. These are research studies that help determine if a new drug is safe and effective. There are two main trials currently underway:

  1. A study combining E7386 with a drug called pembrolizumab in patients with colorectal cancer, melanoma, or liver cancer[1].
  2. A study combining E7386 with other anticancer drugs in patients with liver cancer, colorectal cancer, endometrial cancer, or other solid tumors[2].

These trials are looking at how well E7386 works when combined with other cancer treatments. They are also studying the safety of E7386 and how patients’ bodies process the drug (known as pharmacokinetics)[1][2].

Potential Benefits

While it’s too early to know for sure, researchers hope that E7386 might offer several potential benefits:

  • It may help shrink tumors or slow their growth[1][2].
  • It could potentially work in cancers that haven’t responded to other treatments[1][2].
  • As an oral medication, it might be more convenient for patients than treatments that require infusions or injections[1][2].

Side Effects and Safety

As E7386 is still in clinical trials, all of its potential side effects are not yet known. The ongoing studies are closely monitoring patients for any adverse effects[1][2]. Some general side effects that are often associated with cancer treatments may include fatigue, nausea, and changes in appetite, but the specific side effects of E7386 are still being determined.

Patients in the clinical trials are carefully selected based on specific criteria to ensure their safety. For example, patients must have adequate liver and kidney function, and certain medical conditions may exclude someone from participating in the trial[1][2].

Future Outlook

E7386 is still in the early stages of research, but it represents an exciting new approach to cancer treatment. If the clinical trials show positive results, it could potentially become a new option for patients with certain types of solid tumors, especially those who have not responded to other treatments[1][2].

However, it’s important to remember that drug development is a long and complex process. Even if E7386 continues to show promise, it will likely be several years before it could potentially become available as an approved treatment. In the meantime, researchers will continue to study its effects and safety profile to determine its potential role in cancer treatment[1][2].

Aspect Details
Drug Name E7386
Drug Type Oral tablet
Cancer Types Studied Colorectal cancer, Hepatocellular carcinoma, Melanoma, Endometrial cancer, Other solid tumors
Study Phases Phase 1b/2
Combination Therapies Pembrolizumab, Lenvatinib
Primary Objectives Safety, Tolerability, Determining Recommended Phase 2 Dose
Secondary Objectives Efficacy (ORR, PFS, OS), Pharmacokinetics
Key Eligibility Criteria Advanced solid tumors, Prior treatment history, Adequate organ function
Study Duration Up to 26 weeks or longer

FAQ

  • What is E7386? E7386 is a new drug being tested for the treatment of solid tumors. It is a tablet taken orally and is being studied both alone and in combination with other cancer treatments.
  • What types of cancer is E7386 being tested for? E7386 is being studied for various solid tumors, including colorectal cancer, hepatocellular carcinoma (liver cancer), melanoma, and endometrial cancer.
  • Who is eligible to participate in these clinical trials? Eligibility varies by trial, but generally includes adult patients with advanced solid tumors who have received prior treatment. Specific criteria may include adequate organ function, measurable disease, and particular previous treatment histories.
  • What are the main goals of these clinical trials? The primary goals are to assess the safety and tolerability of E7386, determine the recommended dose for future studies, and evaluate its effectiveness in treating various solid tumors.
  • How long do these clinical trials last? The duration of the trials can vary, but some may last up to 26 weeks or longer, depending on how well the patient responds to treatment and tolerates the medication.

Ongoing Clinical Trials on (6S,9As)-8-((6-(3-(4-Ethyl-1-Piperazinyl)-1-Azetidinyl)-2-Pyridinyl)Methyl)-6-((2-Fluoro-4-Hydroxyphenyl)Methyl)Hexahydro-4,7-Dioxo-N-(Phenylmethyl)-2-(2-Propen-1-Yl)-2H-Pyrazino(2,1-C)(1,2,4)Triazine-1(6H)-Carboxamide

  • Study of E7386 and Lenvatinib for Patients with Liver, Colon, Endometrial, or Other Solid Tumors

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark France Italy Spain

  • Study of E7386 and Pembrolizumab for Patients with Previously Treated Colorectal Cancer, Melanoma, or Hepatocellular Carcinoma

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • Solid tumor: A mass of abnormal cells that does not contain cysts or liquid areas. Solid tumors may be benign or malignant. Examples include carcinomas and sarcomas.
  • Hepatocellular carcinoma (HCC): The most common type of primary liver cancer, which begins in the main type of liver cell (hepatocyte).
  • Colorectal cancer (CRC): Cancer that starts in the colon or rectum, which are parts of the large intestine.
  • Endometrial cancer (EC): Cancer that begins in the lining of the uterus (endometrium).
  • RECIST 1.1: Response Evaluation Criteria in Solid Tumors, version 1.1. A standard way to measure how well a cancer patient responds to treatment.
  • Objective response rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Disease control rate (DCR): The percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response, and stable disease to a therapeutic intervention.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives with cancer without it worsening.
  • Overall survival (OS): The length of time from the start of treatment or diagnosis that patients are still alive.
  • Dose-limiting toxicity (DLT): Side effects of a drug that are severe enough to prevent an increase in dose or level of treatment.
  • Recommended Phase 2 dose (RP2D): The dose of a drug determined in Phase 1 trials to be appropriate for further testing in Phase 2 trials.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.

References

  1. http://clinicaltrials.eu/trial/study-of-e7386-and-pembrolizumab-for-patients-with-previously-treated-colorectal-cancer-melanoma-or-hepatocellular-carcinoma/
  2. http://clinicaltrials.eu/trial/study-of-e7386-and-lenvatinib-for-patients-with-liver-colon-endometrial-or-other-solid-tumors/