All studies
Active not recruitingPHASE1, PHASE2INTERVENTIONAL

A Study of E7386 in Combination With Other Anticancer Drug(s) in Participants With Solid Tumor

This research study is looking at a new drug called E7386, used with other anti-cancer medicines, to treat different types of solid tumours, including cancers of the womb (endometrial), liver, and bowel. The main goal is to find the safest and most effective dose of E7386 when combined with these other treatments. Researchers also want to understand how well these drug combinations work together. While some parts of the study are already full, they are still looking for people with endometrial cancer to help decide the best dose combination. This is an early-stage study to learn more about the drug and its effects.

At a glance

Status
Active not recruiting
Phase
PHASE1, PHASE2
Sponsor
Eisai Inc.
Enrolment target
301
Start
11 Jul 2019
Estimated completion
31 Mar 2027

What is this study about?

This study is a clinical trial, which means it's a research study that involves people. The main purpose of this particular study is to learn more about a new medicine called E7386. Researchers are giving E7386 along with other well-known cancer drugs, such as Lenvatinib, Doxorubicin, and Paclitaxel, to people who have solid tumours. Solid tumours are growths of abnormal cells found in various parts of the body, like the womb, liver, or bowel.

The main things the researchers want to find out are: 1. How safe the combination of E7386 and other cancer drugs is, and what side effects people might experience. 2. What is the best dose of E7386 to give when combined with these other drugs to treat cancer effectively, while keeping side effects manageable.

This study is in its early stages (called Phase 1 and Phase 2), so it's focused on understanding how the drug works and finding the right dose, rather than comparing it to existing standard treatments. Some parts of the study that looked at a wider range of solid tumours are now full. However, the study is currently looking for more people who have endometrial cancer (cancer of the lining of the womb) to help them decide on the very best dose of E7386 to use with Lenvatinib for this specific type of cancer.

Key takeaways

  • Tests a new cancer drug (E7386) with existing treatments.
  • Aims to find the safest and best dose combination.
  • Currently recruiting for participants with endometrial cancer.
  • Early stage study (Phase 1/2) focused on safety and initial effectiveness.
  • Includes people with various solid tumours, including liver and bowel cancer.
  • Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you would generally need to have a confirmed diagnosis of a solid tumour. For those with liver cancer (hepatocellular carcinoma, or HCC), you would need to have cancer that cannot be removed by surgery, and your diagnosis should be confirmed by a biopsy or by specific medical guidelines. If you have other types of solid tumours (not HCC), your cancer should be confirmed by a biopsy, and there should be no other standard or effective treatments available for your condition.

There are also some general health requirements. You should typically expect to live for at least 12 more weeks, and your general health and ability to do daily activities should be good (known as an ECOG Performance Status of 0 or 1). Any side effects from previous cancer treatments, like chemotherapy or radiotherapy, should have mostly cleared up – usually down to a very mild level, except for hair loss or some mild nerve problems.

Your blood pressure, kidney function, bone marrow (which makes blood cells), liver function, and levels of minerals in your blood must all be within a healthy range. You would also need to have at least one tumour that can be measured accurately by scans. There are specific waiting periods after any previous cancer treatments (like chemotherapy, radiotherapy, or antibody treatments) before you can start the study drugs.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Do you have a confirmed solid tumour diagnosis, like endometrial, liver, or bowel cancer?
  2. Is your liver cancer (if applicable) unable to be removed by surgery?
  3. Are there no other standard or effective treatments available for your cancer (for non-liver cancers)?
  4. Do you feel generally well and active in your daily life?
  5. Have any side effects from your previous cancer treatments mostly cleared up?
  6. Are your blood pressure, kidney, liver, and blood cell counts generally healthy?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the doctors and nurses will monitor you very closely. You will be given the study drug E7386 in combination with other anti-cancer medications like Lenvatinib, Doxorubicin, or Paclitaxel. The main aim is to find the best and safest dose of these drug combinations. This means that the dose you receive might be adjusted based on how you respond and any side effects you experience.

You will have regular visits to the clinic for medical check-ups, blood tests, and scans to see how the treatment is affecting your cancer and your overall health. These assessments are important to track the treatment's effectiveness and to check for any side effects. The exact number of visits, tests, and the total duration of your participation would be fully explained by the study team. While the dose-escalation and expansion parts have finished, the current part focuses on finding the best dose for endometrial cancer patients, which involves ongoing assessments. You'll be closely followed up to understand the full effects of the treatment.

Potential risks and benefits

Participating in a clinical trial like this offers potential benefits, such as gaining access to a new drug (E7386) that is not yet widely available, and helping doctors learn more about cancer treatments. This research may improve care for future patients. However, there are also potential risks involved. The new drug and its combinations may cause side effects, some of which could be serious or unexpected. The treatment might not be effective for your cancer. All potential risks and side effects would be fully explained to you before you decide to join. It is very important to remember that participating in a clinical trial is always voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (106)

  • UAMS
    Verified postcode
    Little Rock, United States
  • University of California San Diego (UCSD) - Moores Cancer Center(All)
    Verified postcode
    La Jolla, United States
  • Cedars-Sinai Medical Center
    Verified postcode
    Los Angeles, United States
  • Pasadena Liver Center
    Verified postcode
    Pasadena, United States
  • California Pacific Medical Center
    Verified postcode
    San Francisco, United States
  • UCLA University of California - Los Angeles
    Verified postcode
    Santa Monica, United States
  • John Muir Clinical Research
    Verified postcode
    Walnut Creek, United States
  • University of Colorado Cancer Center - Anschutz Medical Campus
    Verified postcode
    Aurora, United States
  • Uni. Of Miami- Sylvester Cancer Centre
    Verified postcode
    Miami, United States
  • Florida Cancer Specialists - South
    Verified postcode
    Sarasota, United States
  • Florida Cancer Specialists - East
    Verified postcode
    West Palm Beach, United States
  • Women's Cancer Care - Covington, LA
    Verified postcode
    Covington, United States

Common questions

What is E7386?

E7386 is a new experimental drug being studied as a potential cancer treatment, and its safety and effectiveness are being explored in this trial.

What types of cancer is this study looking at?

This study is for people with different types of solid tumours, including advanced liver cancer, and specific parts of the study are currently recruiting only for endometrial cancer (cancer of the womb lining).

Will I receive the new drug only, or other treatments too?

You will receive E7386 in combination with other established anti-cancer drugs like Lenvatinib, Doxorubicin, or Paclitaxel, as the study aims to find the best combination.

What phase is this study in?

This study is in Phase 1 and Phase 2, which are early stages of drug development focused on finding a safe dose and understanding how well the drug works in a small group of patients.

What if I decide I don't want to continue in the study?

You have the right to withdraw from the study at any time, for any reason, without it affecting your ongoing medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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