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Microtubule Inhibitor
E7386 + Lenvatinib for Solid Cancer
Phase 1
Recruiting
Research Sponsored by Eisai Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically confirmed diagnosis of HCC, excluding fibrolamellar, sarcomatoid or mixed cholangio-HCC tumors
Adequate washout period before study drug administration: Chemotherapy and radiotherapy: 3 weeks or 5 times the half-life, whichever is shorter; Any antitumor therapy with antibody: 4 weeks or more; Any investigational drug or device: 4 weeks or more; Blood/platelet transfusion or granulocyte colony-stimulating factor (G-CSF): 2 weeks or more
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose of study drug until death from any cause (up to approximately 60 months)
Awards & highlights
Study Summary
This trialtests a new drug to treat cancer and check if it's safe and effective.
Who is the study for?
This trial is for adults with certain solid tumors like liver cancer, colorectal cancer, or endometrial cancer. They should have a specific stage of disease and no effective standard treatments left to try. Participants need to be relatively healthy otherwise, with good organ function and performance status. Those who've had recent major surgeries or active infections (except hepatitis B/C in liver cancer patients) can't join.Check my eligibility
What is being tested?
The study is testing the safety and best dose of E7386 when combined with another anticancer drug called Lenvatinib in people with various solid tumors. The goal is to find out what amount of E7386 can be given safely without causing too many side effects.See study design
What are the potential side effects?
Possible side effects from E7386 and Lenvatinib may include fatigue, nausea, high blood pressure, reduced appetite, weight loss, diarrhea or constipation. There might also be risks related to liver function changes since these drugs affect how the body fights cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver cancer is confirmed but not fibrolamellar, sarcomatoid, or mixed with bile duct cancer.
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I have not had chemotherapy, radiotherapy, or any cancer treatment within the required waiting periods before starting the study drug.
Select...
I have been diagnosed with liver cancer following AASLD guidelines.
Select...
It's been over 3 weeks or 5 half-lives since my last chemo or radiotherapy.
Select...
I have a tumor that can be measured and has grown despite treatment.
Select...
I can carry out all my daily activities without help.
Select...
My liver cancer is at stage B or C, not suitable for local treatments or surgery.
Select...
I have a confirmed solid tumor diagnosis with no effective standard treatment available.
Select...
I haven't used any experimental drugs or devices in the last 4 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first dose of study drug until death from any cause (up to approximately 60 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of study drug until death from any cause (up to approximately 60 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose Escalation Part: Number of Participants with Dose-limiting Toxicities (DLTs)
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Secondary outcome measures
Clinical Benefit Rate (CBR)
Disease Control Rate (DCR)
Dose Escalation Part: AUC: Area Under the Plasma Concentration Versus Time Curve for E7386
+14 moreTrial Design
8Treatment groups
Experimental Treatment
Group I: Dose Expansion Part: HCC Subpart: Lenvatinib OnlyExperimental Treatment1 Intervention
Participants with HCC will receive lenvatinib 8 mg (participants with body weight of <60 kg) or 12 mg (participants with body weight >=60 kg), capsules, orally, QD in 28-day treatment cycles until PD, development of unacceptable toxicity, participant request to discontinue, withdrawal of consent, or termination of the study program.
Group II: Dose Expansion Part: HCC Subpart: E7386 + LenvatinibExperimental Treatment2 Interventions
Participants with HCC will receive lenvatinib 8 mg (participants with body weight of <60 kg) or 12 mg (participants with body weight >=60 kg), capsule, orally QD in combination with E7386 tablets, orally, BID in 28-day treatment cycles until PD, development of unacceptable toxicity, participant request to discontinue, withdrawal of consent, or termination of the study program. E7386 dose will be determined from recommended dose level of the HCC BID Subpart in Dose Escalation Part.
Group III: Dose Expansion Part: EC Subpart: E7386 + LenvatinibExperimental Treatment2 Interventions
Participants with endometrial cancer (EC) will receive E7386 tablets, orally, BID in combination with lenvatinib 14 mg, capsules, orally, QD in 28-day treatment cycles until PD, development of unacceptable toxicity, participant request to discontinue, withdrawal of consent, or termination of the study program. E7386 dose will be determined from recommended dose level of the ST BID Subpart in Dose Escalation Part.
Group IV: Dose Expansion Part: CRC Subpart: E7386 + LenvatinibExperimental Treatment2 Interventions
Participants with colorectal cancer (CRC) will receive E7386 tablets, orally, BID in combination with lenvatinib 20 mg, capsules, orally, QD in 28-day treatment cycles until PD, development of unacceptable toxicity, participant request to discontinue, withdrawal of consent, or termination of the study program. E7386 dose will be determined from recommended dose level of the ST BID Subpart in Dose Escalation Part.
Group V: Dose Escalation Part: Other ST: E7386 QD Subpart + LenvatinibExperimental Treatment2 Interventions
Participants with solid tumor (ST) (except for HCC) will receive E7386 tablets, alone orally, QD for 5 or 6 consecutive days followed by 48 hours of without treatment in Cycle 0 (6 or 7 days). Participants with ST (except for HCC) will receive E7386 tablets, orally, QD in combination with lenvatinib 20 mg, capsules, orally, QD in 28-day treatment cycles until PD, development of unacceptable toxicity, participant request to discontinue, withdrawal of consent, or termination of the study program. Dose escalation of E7386 will be based on the available safety data from the previous cohorts.
Group VI: Dose Escalation Part: Other ST: E7386 BID Subpart + LenvatinibExperimental Treatment2 Interventions
Participants with ST (except for HCC) will receive E7386 tablets, alone orally, BID for 5 or 6 consecutive days in Cycle 0 (6 or 7 days). Participants with ST (except for HCC) will receive E7386 tablets, orally, BID in combination with lenvatinib 20 mg, capsules, orally, QD in 28-day treatment cycles until PD, development of unacceptable toxicity, participant request to discontinue, withdrawal of consent, or termination of the study program. Dose escalation of E7386 will be based on the available safety data from the previous cohorts.
Group VII: Dose Escalation Part: HCC: E7386 QD Subpart + LenvatinibExperimental Treatment2 Interventions
Participants with hepatocellular carcinoma (HCC) will receive E7386 tablets, orally, QD for 5 or 6 consecutive days followed by 48 hours of without treatment in Cycle 0 (6 or 7 days). Participants with HCC will receive E7386 tablets, orally, QD in combination with lenvatinib 8 milligram (mg) (participants with body weight of less than [<] 60 kg) or 12 mg (participants with body weight >=60 kg), capsules, orally, QD in 28-day treatment cycles until PD, development of unacceptable toxicity, participant request to discontinue, withdrawal of consent, or termination of the study program. Dose escalation of E7386 will be based on the available safety data from the previous cohorts.
Group VIII: Dose Escalation Part: HCC: E7386 BID Subpart + LenvatinibExperimental Treatment2 Interventions
Participants with HCC will receive E7386 tablets, orally, BID for 5 or 6 consecutive days in Cycle 0 (6 or 7 days). Participants with HCC will receive E7386 tablets, orally, BID in combination with lenvatinib 8 mg (participants with body weight of < 60 kg) or 12 mg (participants with body weight >=60 kg) capsules, orally, QD in 28-day treatment cycles until PD, development of unacceptable toxicity, participant request to discontinue, withdrawal of consent, or termination of the study program. Dose escalation of E7386 will be based on the available safety data from the previous cohorts.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
E7386
2019
Completed Phase 1
~20
Lenvatinib
2005
Completed Phase 4
~2690
Find a Location
Who is running the clinical trial?
Eisai Inc.Lead Sponsor
515 Previous Clinical Trials
158,790 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had blood transfusions or G-CSF treatments in the last 2 weeks and have recovered from any radiation side effects without needing steroids.I am currently infected with COVID-19 or still recovering from its effects.My blood pressure, kidney, liver, bone marrow functions, and mineral levels are all within normal ranges.My liver cancer is confirmed but not fibrolamellar, sarcomatoid, or mixed with bile duct cancer.My side effects from previous cancer treatments are mild, except for hair loss or some nerve pain.I have not had chemotherapy, radiotherapy, or any cancer treatment within the required waiting periods before starting the study drug.I have been diagnosed with liver cancer following AASLD guidelines.It's been over 3 weeks or 5 half-lives since my last chemo or radiotherapy.I have colorectal cancer, tried 2-4 treatments, and received specific therapies if available.I have recovered from all side effects of radiation and don't need steroids.I have HCC and have only had one prior IO treatment or none if I'm IO ineligible, but haven't had lenvatinib.I do not have an active infection needing treatment, except for HBV/HCV if I have liver cancer.My urine protein levels are below 1 gram per 24 hours.I have hepatitis B or C and my treatment isn't controlling it well.I can carry out all my daily activities without help.I have a confirmed diagnosis of a specific type of liver cancer that cannot be surgically removed.I have EC and my disease progressed after treatment, including platinum and/or IO therapies.I have a tumor that can be measured and has grown despite treatment.I have been diagnosed with cancer that has spread to the lining of my brain and spinal cord.I stopped lenvatinib or had to lower its dose due to side effects.I am HIV positive.I am scheduled for a major surgery during the study period.I have a severe fistula.I have had episodes of confusion due to liver disease in the last 6 months.You have a mental health or drug addiction issue that could make it difficult for you to follow the study's instructions.I have a serious health condition that could affect my safety or interfere with the study.I have heart issues like heart failure, recent heart attack, or weak heart pumping.I haven't had any cancer except for my current one or certain skin cancers in the last 2 years.I need treatment for lung problems caused by cancer, including oxygen.I am a male without a successful vasectomy and my partner can still have children.My brain metastases are stable, treated, and I haven't needed steroids for 2 weeks.It has been over 4 weeks since my last antibody cancer treatment.I had major surgery more than 21 days ago or minor surgery more than 7 days ago and have recovered.I have a bleeding disorder or I'm on blood thinners that need INR monitoring.My liver cancer is at stage B or C, not suitable for local treatments or surgery.My cancer is one of the following types: carcinosarcoma, endometrial leiomyosarcoma, or endometrial stromal sarcoma.I have a confirmed solid tumor diagnosis with no effective standard treatment available.I have a solid tumor with no standard or effective treatment options left.You are expected to live for at least 12 more weeks.I haven't had significant bleeding or coughed up blood in the last 3 weeks.I haven't used any experimental drugs or devices in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Expansion Part: HCC Subpart: Lenvatinib Only
- Group 2: Dose Expansion Part: HCC Subpart: E7386 + Lenvatinib
- Group 3: Dose Expansion Part: EC Subpart: E7386 + Lenvatinib
- Group 4: Dose Escalation Part: HCC: E7386 BID Subpart + Lenvatinib
- Group 5: Dose Escalation Part: HCC: E7386 QD Subpart + Lenvatinib
- Group 6: Dose Escalation Part: Other ST: E7386 QD Subpart + Lenvatinib
- Group 7: Dose Escalation Part: Other ST: E7386 BID Subpart + Lenvatinib
- Group 8: Dose Expansion Part: CRC Subpart: E7386 + Lenvatinib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA given its seal of approval to any treatments for Hepatocellular Carcinoma (HCC)?
"Considering the limited data that exists for Hepatocellular carcinoma Part's efficacy and safety, our team at Power assigned it a score of 1."
Answered by AI
How many individuals are partaking in this medical survey?
"Indeed, according to information found on clinicaltrials.gov, this research study has opened up recruitment opportunities since 11/7/2019 and was last updated on 9/11/2022. The aim is to select 181 patients from 5 distinct medical institutions."
Answered by AI
Where can people access this clinical trial?
"This research is being conducted at 5 distinct medical institutions, such as the Medical University of South carolina in Charleston and Mary Crowley Cancer Research in Dallas. Additionally, there are a trio of other locations that are involved with this trial including Kansas City Research Institute in Kansas City."
Answered by AI
Are additional participants being welcomed into this research endeavor?
"According to clinicaltrials.gov, this investigation is currently open for enrolment. Originally posted on July 11th 2019 and last updated November 9th 2022, the trial offers potential participants a chance to participate in research."
Answered by AI
Has research been conducted on the potential benefits of Hepatocellular Carcinoma (HCC) Treatment?
"Currently, 148 clinical trials dedicated to the research of Hepatocellular carcinoma (HCC) Part are ongoing. Of those trials, 32 have progressed to Phase 3 testing. Despite being primarily based in Iowa City, Iowa, there are 4997 medical centres running these experiments across America."
Answered by AI
Is this the maiden exploration into this particular research area?
"Presently, 148 ongoing trials for Hepatocellular carcinoma (HCC) are being carried out in 1017 cities and 53 countries. The initial investigation of HCC, sponsored by Merck Sharp & Dohme Corp., began in 2016 and involved 576 participants who finished Phase 1 drug approval testing. Since then, an additional 55 clinical studies have been undertaken on the matter."
Answered by AI
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