Hepatocellular Carcinoma (HCC) Part for Hepatocellular Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Hepatocellular Carcinoma+4 MoreE7386 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The primary objective of this study is to assess the safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of E7386 in combination with other anticancer drug(s).

Eligible Conditions
  • Hepatocellular Carcinoma
  • Tumors
  • Liver Tumors
  • Endometrial Cancer
  • Colorectal Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

3 Primary · 22 Secondary · Reporting Duration: From first dose of study drug until death from any cause (up to approximately 60 months)

Day 28
Dose Escalation Part: Number of Participants with Dose-limiting Toxicities (DLTs)
Day 28
Number of Participants with Dose-limiting Toxicities (DLTs)
Day 28
Dose Escalation Part: AUC: Area Under the Plasma Concentration Versus Time Curve for Lenvatinib
Dose Escalation Part: CL/F: Apparent Total Body Clearance for Lenvatinib
Dose Escalation Part: Cmax: Maximum Observed Plasma Concentration for Lenvatinib
Dose Escalation Part: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Lenvatinib
Dose Escalation Part: Vz/F: Apparent Volume of Distribution for Lenvatinib
Month 60
Clinical Benefit Rate (CBR)
Disease Control Rate (DCR)
Objective Response Rate (ORR)
Month 60
Duration of Response (DOR)
Progression-free Survival (PFS)
Month 60
Overall Survival (OS)
Month 60
Percentage of Participants with Best Overall Response (BOR)
Day 28
AUC: Area Under the Plasma Concentration Versus Time Curve for E7386
CL/F: Apparent Total Body Clearance for E7386
Cmax: Maximum Observed Plasma Concentration for E7386
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E7386
Vz/F: Apparent Volume of Distribution for E7386
Day 28
Dose Escalation Part: AUC: Area Under the Plasma Concentration Versus Time Curve for E7386
Dose Escalation Part: CL/F: Apparent Total Body Clearance for E7386
Dose Escalation Part: Cmax: Maximum Observed Plasma Concentration for E7386
Dose Escalation Part: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E7386
Dose Escalation Part: Vz/F: Apparent Volume of Distribution for E7386
Month 60
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Trial Safety

Safety Progress

1 of 3

Similar Trials

Trial Design

12 Treatment Groups

HCC: E7386 QD Part
1 of 12
HCC: E7386: BID Part
1 of 12
Other ST: E7386 QD Part
1 of 12
Dose Escalation Part: Other ST: E7386 QD Subpart + Lenvatinib
1 of 12
Dose Escalation Part: Other ST: E7386 BID Subpart + Lenvatinib
1 of 12
Dose Expansion Part: HCC Subpart: Lenvatinib Only
1 of 12
Dose Escalation Part: HCC: E7386 QD Subpart + Lenvatinib
1 of 12
Dose Escalation Part: HCC: E7386 BID Subpart + Lenvatinib
1 of 12
Dose Expansion Part: EC Subpart: E7386 + Lenvatinib
1 of 12
Dose Expansion Part: CRC Subpart: E7386 + Lenvatinib
1 of 12
Dose Expansion Part: HCC Subpart: E7386 + Lenvatinib
1 of 12
Other ST: E7386 BID Part
1 of 12

Experimental Treatment

181 Total Participants · 12 Treatment Groups

Primary Treatment: Hepatocellular Carcinoma (HCC) Part · No Placebo Group · Phase 1

HCC: E7386 QD PartExperimental Group · 2 Interventions: E7386, Lenvatinib · Intervention Types: Drug, Drug
HCC: E7386: BID PartExperimental Group · 2 Interventions: E7386, Lenvatinib · Intervention Types: Drug, Drug
Other ST: E7386 QD PartExperimental Group · 2 Interventions: E7386, Lenvatinib · Intervention Types: Drug, Drug
Dose Escalation Part: Other ST: E7386 QD Subpart + LenvatinibExperimental Group · 2 Interventions: E7386, Lenvatinib · Intervention Types: Drug, Drug
Dose Escalation Part: Other ST: E7386 BID Subpart + LenvatinibExperimental Group · 2 Interventions: E7386, Lenvatinib · Intervention Types: Drug, Drug
Dose Expansion Part: HCC Subpart: Lenvatinib Only
Drug
Experimental Group · 1 Intervention: Lenvatinib · Intervention Types: Drug
Dose Escalation Part: HCC: E7386 QD Subpart + LenvatinibExperimental Group · 2 Interventions: E7386, Lenvatinib · Intervention Types: Drug, Drug
Dose Escalation Part: HCC: E7386 BID Subpart + LenvatinibExperimental Group · 2 Interventions: E7386, Lenvatinib · Intervention Types: Drug, Drug
Dose Expansion Part: EC Subpart: E7386 + LenvatinibExperimental Group · 2 Interventions: E7386, Lenvatinib · Intervention Types: Drug, Drug
Dose Expansion Part: CRC Subpart: E7386 + LenvatinibExperimental Group · 2 Interventions: E7386, Lenvatinib · Intervention Types: Drug, Drug
Dose Expansion Part: HCC Subpart: E7386 + LenvatinibExperimental Group · 2 Interventions: E7386, Lenvatinib · Intervention Types: Drug, Drug
Other ST: E7386 BID PartExperimental Group · 2 Interventions: E7386, Lenvatinib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
E7386
2019
Completed Phase 1
~20
Lenvatinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from first dose of study drug until death from any cause (up to approximately 60 months)

Who is running the clinical trial?

Eisai Inc.Lead Sponsor
506 Previous Clinical Trials
144,878 Total Patients Enrolled
4 Trials studying Hepatocellular Carcinoma
330 Patients Enrolled for Hepatocellular Carcinoma

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with a solid tumor for which no standard or effective treatment is available.
Your life expectancy is estimated to be at least 12 weeks.
You have an Eastern Cooperative Oncology Group (ECOG) Performance Status between 0 and 1.
Chemotherapy and radiotherapy should be administered within 3 weeks or 5 times the half-life, whichever is shorter.
You have received an antitumor therapy with antibody for four weeks or longer.
You have been taking an investigational drug or device for at least four weeks.
You have received a blood/platelet transfusion or G-CSF at least two weeks ago, are not using corticosteroids and have fully recovered from radiation-related toxicities including pneumonitis.
You have been identified as having Hepatocellular Carcinoma, except for fibrolamellar, sarcomatoid or mixed cholangio-HCC tumors.
You have a clinically verified diagnosis of HCC as per the American Association for the Study of Liver Diseases (AASLD) guidelines, including cirrhosis caused by any factor and/or chronic hepatitis B or C infection.
All adverse events caused by previous cancer treatment have been restored to Grade 0 or 1, with the exception of alopecia, or up to Grade 2 peripheral neuropathy (with renal/bone marrow/liver function meeting requirements for inclusion).