Study on E7386 Combined with Other Cancer Drugs for Patients with Solid Tumors
Sponsor: Eisai Inc.
ClinicalTrials ID:NCT04008797
This clinical trial is testing the safety and best dose of a new drug, E7386, when used with other cancer treatments. The study focuses on patients with solid tumors, including those with endometrial cancer, to find the most effective dose combination.
Patient Parameters
| Parameter | Options |
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Program Overview
The main goal of this study is to determine how safe and tolerable the drug E7386 is when combined with other cancer drugs. Researchers are also looking to find the best dose of E7386 when used with the drug lenvatinib specifically for endometrial cancer. This study involves patients with various solid tumors, including those with liver cancer (HCC) and endometrial cancer (EC), to see how well the drug combinations work.
Eligibility Criteria
Inclusion Criteria
- For liver cancer (HCC) patients: Must have a confirmed diagnosis of liver cancer that cannot be removed by surgery.
- For other solid tumors: Must have a confirmed diagnosis of a solid tumor with no other effective treatment options.
- Must have a life expectancy of at least 12 weeks.
- Must be in good general health, with an ECOG performance status of 0 or 1.
- Must have recovered from any side effects of previous cancer treatments.
- Must have normal blood pressure, kidney, liver, and bone marrow function.
- Must have at least one measurable tumor that can be tracked using scans.
- For liver cancer patients: Must have a Child-Pugh score of A.
- For liver cancer patients: Must be at stage B or C according to the BCLC staging system.
- For endometrial cancer patients: Must have cancer that has progressed after previous treatments, including platinum-based chemotherapy and anti-PD-1 therapy.
Exclusion Criteria
- Have certain heart conditions, such as heart failure or abnormal heart rhythms.
- Have had major surgery within the last 21 days or minor surgery within the last 7 days.
- Are HIV positive.
- Have significant protein in the urine.
- Have an active infection requiring treatment.
- Have cancer that has spread to the brain unless it has been treated and is stable.
- Have certain bone diseases or conditions.
- Have had another type of cancer within the last 24 months.
- For liver cancer patients: Have had issues with lenvatinib treatment in the past.
- Have bleeding or clotting disorders.
- Have had recent gastrointestinal bleeding or coughing up blood.
- For liver cancer patients: Have had hepatic encephalopathy in the last 6 months.
- For endometrial cancer patients: Have certain types of endometrial cancer.
- Have a severe gastrointestinal or non-gastrointestinal fistula.
- Have an active COVID-19 infection.
- Are male and have not had a vasectomy, and their female partners are of childbearing potential and not using effective contraception.
- Have a psychiatric or substance abuse disorder that would interfere with the study.
- Have any other significant medical conditions that could affect safety or study results.
- Are scheduled for major surgery during the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California San Diego (UCSD) - Moores Cancer Center(All) | 92037 | La Jolla | California |
| Cedars-Sinai Medical Center | 90048 | Los Angeles | California |
| Pasadena Liver Center | 91105 | Pasadena | California |
| UCLA University of California - Los Angeles | 90404 | Santa Monica | California |
| University of Colorado Cancer Center - Anschutz Medical Campus | 80045 | Aurora | Colorado |
| Florida Cancer Specialists - South | 34236 | Sarasota | Florida |
| Florida Cancer Specialists - East | 33401 | West Palm Beach | Florida |
| Kansas City Research Institute | 64131 | Kansas City | Missouri |
| Perlmutter Cancer Center- NYU Langone Health | 10016 | New York | New York |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
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