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

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for people with different types of solid tumors, which are abnormal masses of tissue that can occur in various parts of the body. The specific types of cancer being studied include hepatocellular carcinoma (a type of liver cancer), colorectal cancer (cancer of the colon or rectum), and endometrial cancer (cancer of the lining of the uterus), among others. The treatment being tested involves a combination of a new drug called E7386 and another anticancer medication known as Lenvima (lenvatinib). E7386 is taken in the form of a tablet, while Lenvima is provided as hard capsules.

The purpose of this study is to evaluate the safety and tolerability of E7386 when used with other anticancer drugs and to determine the best dose for future studies. Participants in the trial will receive the study medications over a period of up to 26 weeks. The study will monitor how the body responds to the treatment and any side effects that may occur. Participants will take the medications orally, meaning they will swallow them, and will be regularly checked by the study team to ensure their safety and to track the progress of their treatment.

Throughout the study, researchers will collect information on how well the treatment works in controlling the cancer, including measuring the size of the tumors and checking for any signs of cancer progression. The study will also look at how long participants live after starting the treatment and how long any positive effects of the treatment last. This information will help determine if the combination of E7386 and Lenvima is a promising option for treating solid tumors in future clinical trials.

1 joining the study

Upon joining the study, the participant will be informed about the trial’s purpose, which is to assess the safety and tolerability of the drug E7386 in combination with other anticancer drugs.

The participant will be required to provide informed consent, acknowledging understanding of the study’s procedures and potential risks.

2 initial assessment

An initial assessment will be conducted to confirm eligibility, including a review of medical history and current health status.

The participant must have a confirmed diagnosis of a solid tumor, such as hepatocellular carcinoma, colorectal cancer, or endometrial cancer, and meet specific health criteria.

3 treatment phase

The participant will begin treatment with E7386 and Lenvima (lenvatinib).

The dosage for Lenvima will be either 10 mg or 4 mg, administered orally in the form of hard capsules.

The treatment will continue as prescribed by the study protocol, with regular monitoring to assess the participant’s response and any side effects.

4 monitoring and follow-up

Throughout the study, the participant will undergo regular check-ups to monitor health status and the effectiveness of the treatment.

These check-ups will include physical examinations, imaging tests, and laboratory tests to evaluate the progression of the disease and any adverse effects.

5 completion of the study

Upon completion of the study, the participant will have a final assessment to determine the overall impact of the treatment.

The study aims to conclude by January 31, 2025, with results contributing to the understanding of the drug’s safety and effectiveness.

Who Can Join the Study?

Patients must have a confirmed diagnosis of one of the following: hepatocellular carcinoma (HCC), colorectal cancer (CRC), endometrial cancer (EC), or another solid tumor.
For HCC patients: The cancer must be unresectable (cannot be removed by surgery) and confirmed by tests or clinical criteria.
For other solid tumor patients: The cancer must be confirmed by tests, and there should be no other standard or effective treatment options available.
Patients must have adequate liver function, meaning the liver is working well enough.
Patients must have adequate serum mineral levels, which means the minerals in the blood are at healthy levels.
Patients must have at least one measurable lesion (an area of cancer that can be measured) that meets specific size criteria.
For HCC patients: Must have a Child-Pugh score A, which is a way to assess liver function.
For HCC patients: Must be in stage B or C according to a specific liver cancer staging system.
For HCC patients in the expansion part: Must have had prior systemic therapy for advanced disease, with specific conditions on previous treatments.
For CRC patients in the expansion part: Must have had at least 2 prior treatment regimens and specific prior therapies if available.
For EC patients in the expansion part: Must show disease progression after prior systemic therapy and have received specific treatments.
Patients must have a life expectancy of at least 12 weeks.
Patients must have an ECOG performance status of 0-1, which measures daily living abilities.
All side effects from previous cancer treatments must have improved to a certain level, except for hair loss or mild nerve damage.
There must be an adequate washout period (time without treatment) before starting the study drug, depending on the type of previous treatment.
Patients must have adequately controlled blood pressure.
Patients must have adequate renal function, meaning the kidneys are working well enough.
Patients must have adequate bone marrow function, meaning the bone marrow is producing enough blood cells.
Both male and female patients are eligible.
Patients must be within the specified age range for the study.

Who Cannot Join the Study?

Patients with certain types of cancer, such as hepatocellular carcinoma (a type of liver cancer), colorectal cancer (cancer of the colon or rectum), endometrial cancer (cancer of the lining of the uterus), or other solid tumors, may not be eligible.
Patients who are not within the specified age range for the study may be excluded.
Patients who are part of a vulnerable population, which means they might need special protection or care, may not be eligible.
Patients who do not meet the safety and tolerability requirements for the study may be excluded.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Centr Georges Francois Leclerc	Dijon	France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Centre Jean Perrin	Clermont Ferrand	France
Hospital Clinico San Carlos	Madrid	Spain
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
CHU Grenoble Alpes	La Tronche	France
Comite Entreprise Paul Papin	Angers	France

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Universitario De Jaen	Jaen	Spain
Odense University Hospital	Odense	Denmark
Universita’ Politecnica Delle Marche	Ancona	Italy
Groupe Hospitalier Diaconesses Croix Saint Simon	Paris	France
Rigshospitalet	Copenhagen	Denmark
Hopital Beaujon	Clichy	France
Institut Curie – Site Saint-Cloud	Saint-Cloud	France
Centre Francois Baclesse	Caen	France
Hrzaggzvh Mrxddamd Sbfocn	Milan	Italy
Ctqltm Lcng Bxfvov	Lyon	France
Cwz Ckenn Rbifxjbblgh	Lyon	France
Hqmlzztg Ugmuhbwfhbicfn Ssjusnbnqr &zgdfzo Hzloneu dh Hkbpprizdcz	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.05.2023
France	Not recruiting	01.05.2023
Italy	Not recruiting	01.05.2023
Spain	Not recruiting	01.05.2023

Trial locations

Investigated drugs:

E7386 is an investigational medication being studied for its potential use in treating solid tumors. It is part of a clinical trial to evaluate its safety and how well it is tolerated when used in combination with other cancer treatments. The goal is to find the best dose to use in future studies.

Investigated diseases:

Hepatocellular carcinoma – This is the most common type of primary liver cancer, originating in the liver cells known as hepatocytes. It often develops in the context of chronic liver disease, such as cirrhosis or hepatitis. The disease may initially present with symptoms like abdominal pain, weight loss, or jaundice. As it progresses, the tumor can grow and spread to other parts of the body, potentially affecting liver function and overall health.

Colorectal cancer – This cancer begins in the colon or rectum, parts of the large intestine, and is often grouped together due to their similarities. It typically starts as a growth called a polyp on the inner lining of the colon or rectum, which can become cancerous over time. Symptoms may include changes in bowel habits, blood in the stool, and abdominal discomfort. As the cancer advances, it can invade deeper layers of the colon or rectum and spread to other organs.

Endometrial cancer – This type of cancer originates in the lining of the uterus, known as the endometrium. It is most commonly diagnosed in postmenopausal women and often presents with abnormal uterine bleeding. The cancer can grow and invade the muscular layer of the uterus and beyond. If not detected early, it may spread to other parts of the body, affecting overall health.

Other solid tumors – This term refers to a diverse group of cancers that form solid masses in various organs or tissues, excluding blood cancers. These tumors can arise in different parts of the body, such as the lungs, pancreas, or kidneys. The progression of solid tumors varies widely depending on their location, type, and growth rate. Symptoms and effects on the body depend on the tumor’s size, location, and whether it has spread to other areas.

Trial ID:

2023-510275-64-00

Protocol code:

E7386-J081-102

NCT ID:

NCT04008797

Trial Phase:

Human Pharmacology (Phase I) – Other

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?