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Microtubule Inhibitor

E7386 + Lenvatinib for Solid Cancer

Phase 1 & 2

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

Must not have

Evidence of current COVID-19 infection or ongoing unrecovered active sequelae of COVID-19 infection

Participants with proteinuria >1 positive on urine dipstick testing will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein >=1 gram per 24 hour will be ineligible

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

No Placebo-Only Group

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.

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.

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 below

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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.

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I have been diagnosed with liver cancer following AASLD guidelines.

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It's been over 3 weeks or 5 half-lives since my last chemo or radiotherapy.

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I have a tumor that can be measured and has grown despite treatment.

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I can carry out all my daily activities without help.

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My liver cancer is at stage B or C, not suitable for local treatments or surgery.

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I have a confirmed solid tumor diagnosis with no effective standard treatment available.

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I haven't used any experimental drugs or devices in the last 4 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently infected with COVID-19 or still recovering from its effects.

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My urine protein levels are below 1 gram per 24 hours.

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I have been diagnosed with cancer that has spread to the lining of my brain and spinal cord.

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I am HIV positive.

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I am scheduled for a major surgery during the study period.

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I have a severe fistula.

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I have had episodes of confusion due to liver disease in the last 6 months.

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I have heart issues like heart failure, recent heart attack, or weak heart pumping.

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I need treatment for lung problems caused by cancer, including oxygen.

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I had major surgery more than 21 days ago or minor surgery more than 7 days ago and have recovered.

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I haven't had significant bleeding or coughed up blood in the last 3 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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study drug until death from any cause (up to approximately 60 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose Escalation Part: Number of Participants with Dose-limiting Toxicities (DLTs)

Dose Optimization Part: Objective Response Rate (ORR) per RECIST 1.1 by Investigator Assessment at Week 24

Secondary study objectives

Clinical Benefit Rate (CBR)

Disease Control Rate (DCR)

Duration of Response (DOR)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

9Treatment groups

Experimental Treatment

Group I: Dose Optimization Part: EC ParticipantsExperimental Treatment4 Interventions

Participants with EC will be randomized to receive 2 different doses of E7386 in combination with lenvatinib capsule or lenvatinib capsule monotherapy in 28-days cycles, or treatment of physician's choice (TPC; doxorubicin in 21-day cycles or paclitaxel in 28-day cycles \[3 weeks on/1 week off\]), 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: 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 III: 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 y, 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.

Group IV: Dose Expansion Part: EC Subpart: E7386 + LenvatinibExperimental Treatment2 Interventions

Participants with endometrial cancer (EC) will receive E7386, 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.

Group V: Dose Expansion Part: CRC Subpart: E7386 + LenvatinibExperimental Treatment2 Interventions

Participants with colorectal cancer (CRC) will receive E7386, 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.

Group VI: Dose Escalation Part: Other ST: E7386 QD Subpart + LenvatinibExperimental Treatment2 Interventions

Participants with solid tumor (ST) (except for HCC) will receive E7386, QD for 5 or 6 consecutive days followed by a period of time without treatment in Cycle 0 (6 or 7 days). Participants with ST (except for HCC) will receive E7386, 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.

Group VII: Dose Escalation Part: Other ST: E7386 BID Subpart + LenvatinibExperimental Treatment2 Interventions

Participants with ST (except for HCC) will receive E7386, BID for 5 or 6 consecutive days in Cycle 0 (6 or 7 days). Participants with ST (except for HCC) will receive E7386, 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.

Group VIII: Dose Escalation Part: HCC: E7386 QD Subpart + LenvatinibExperimental Treatment2 Interventions

Participants with hepatocellular carcinoma (HCC) will receive E7386, once daily (QD) for 5 or 6 consecutive days followed by a period of time without treatment in Cycle 0 (6 or 7 days). Participants with HCC will receive E7386, QD in combination with lenvatinib 8 milligram (mg) (participants with body weight of less than \[\<\] 60 kilograms \[kg\]) 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 IX: Dose Escalation Part: HCC: E7386 BID Subpart + LenvatinibExperimental Treatment2 Interventions

Participants with HCC will receive E7386, twice daily (BID) for 5 or 6 consecutive days in Cycle 0 (6 or 7 days). Participants with HCC will receive E7386, 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Doxorubicin

2012

Completed Phase 3

~8030

Paclitaxel

2011

Completed Phase 4

~5370