Neoplasms

All Conditions

Digestive System Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Carcinoma

Colorectal Neoplasms

Carcinoma, Hepatocellular

Melanoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Adenocarcinoma

Liver Neoplasms

Liver Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Lenvatinib

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Participants will receive E7386 twice daily (BID) along with pembrolizumab 200 mg intravenous (IV) infusion once every 3 weeks (Q3W) in 21-day treatment cycle until RP2D is determined in Phase 1b. The recommended dose for Phase 2 part of the study will be based on Phase 1b result. Participants will continue to receive study treatment in Phase 2 part until disease progression, development of unacceptable toxicity, withdrawal of consent, or termination of the study.

Participants will be randomized to receive E7386 Dose 1 (Cohort 1) or Dose 2 (Cohort 2) tablet, BID, orally in combination with pembrolizumab 200 mg Q3W IV infusion plus lenvatinib 8 mg capsule, orally, once daily (QD) continuously in 21-days treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or termination of the study. The dose of treatment depends on tolerability data of both Cohorts.

E7386

Eisai Medical Information

The Phase 1b part of this study is conducted to assess the safety and tolerability of E7386 in combination with pembrolizumab in participants with previously treated selected solid tumors, and to determine the recommended Phase 2 dose (RP2D) of E7386 in combination with pembrolizumab.

The Phase 2 part of this study is conducted to assess the objective response rate (ORR) of E7386 in combination with pembrolizumab (melanoma, colorectal cancer \[CRC\], hepatocellular carcinoma \[HCC\]) or of E7386 in combination with pembrolizumab plus lenvatinib (HCC) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

A Study of E7386 in Combination With Pembrolizumab in Previously Treated Participants With Selected Solid Tumors

An Open-Label, Multicenter, Phase 1b/2 Study of E7386 in Combination With Pembrolizumab in Previously Treated Subjects With Selected Solid Tumors

Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

DLTs are any pre-specified toxicities occurring during Cycle 1, based on investigator assessment as related to study drug. All adverse events (AEs) of the specified grades should count as DLTs except those that are clearly and incontrovertibly due to disease progression or extraneous causes. DLTs will be assessed to determine the RP2D of E7386 in combination with pembrolizumab. All toxicity will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

ORR is defined as the percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

BOR is defined as CR, PR, stable disease (SD), PD, and not evaluable (NE), where SD has to be achieved at greater than equal to (\>=) 5 weeks after the first dose per RECIST version 1.1.

DOR is defined as the time from the first documentation of CR or PR to the first documentation of disease progression or death due to any causes, whichever occurs first in participants with confirmed CR or PR as per RECIST version 1.1.

DCR is defined as the percentage of participants with BOR of confirmed CR, PR, or SD after \>=5 weeks from first dose per RECIST version 1.1.

CBR is defined as the percentage of participants who have a BOR of confirmed CR, PR, or durable SD (duration of SD \>=23 weeks) per RECIST 1.1.

DLTs are any pre-specified toxicities occurring during Cycle 1, based on investigator assessment as related to study drug. All AEs of the specified grades should count as DLTs except those that are clearly and incontrovertibly due to disease progression or extraneous causes. All toxicity will be graded using NCI CTCAE version 5.0.

Merck Sharp & Dohme LLC

Eisai Inc.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

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.

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.

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.

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.

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.

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.

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.

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.

Eisai Inquiry Service

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).

A Study of E7386 in Combination With Other Anticancer Drug in Participants With Solid Tumor

An Open-label Phase 1b Study of E7386 in Combination With Other Anticancer Drug(s) in Subjects With Solid Tumors

DLT will be defined as any of the events that are considered by the investigator to be at least possibly related to therapy with the study medication. Toxicity will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE 5.0).

Here BID is twice daily and QD is once daily.

BOR is defined as confirmed complete response (CR), confirmed partial response (PR), stable disease (SD), PD, and not evaluable (NE), where SD has to be achieved at greater than or equal to (\>=) 7 weeks after the first dose. The BOR will be assessed by investigator based on Modified Response Evaluation Criteria in Solid Tumors (mRECIST) for HCC subparts in dose escalation part and based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for ST subparts in dose escalation part, and for HCC subpart, CRC subpart, EC subpart in dose expansion part.

The ORR is defined as the percentage of participants with a BOR of CR or PR. The ORR will be assessed by investigator based on mRECIST for HCC subparts in dose escalation part and based on RECIST version 1.1 for ST-subparts in dose escalation part, and for HCC subpart, CRC subpart, EC subpart in dose expansion part.

DCR is defined as the percentage of participants with a BOR of CR, PR, or SD after \>=7 weeks from the first dose. The DCR will be assessed by investigator based on mRECIST for HCC subparts in dose escalation part and based on RECIST version 1.1 for ST-subparts in dose escalation part, and for HCC subpart, CRC subpart, EC subpart in dose expansion part.

The CBR is defined as the percentage of participants with a BOR of CR, PR, or durable SD (duration of SD \>=23 weeks). The CBR will be assessed by investigator based on mRECIST for HCC subparts in dose escalation part and based on RECIST version 1.1 for ST-subparts in dose escalation part, and for HCC subpart, CRC subpart, EC subpart in dose expansion part.

PFS is defined as the time from the date of the first dose to the date of the first documentation of confirmed PD or death, whichever occurs first.

OS is defined as the time from the first dose of study drug to death due to any cause. OS will be calculated for all subparts in dose expansion part and HCC subparts in dose escalation part only.

DOR is defined as the time from the first documentation of PR or CR to the first documentation of disease progression or death due to any cause (whichever occurs first).

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Fibromatosis, Aggressive

Adrenocortical Carcinoma

Pancreatic Cancer

Gastro-enteropancreatic Neuroendocrine Tumor

Desmoid Tumor

Small Intestine Cancer

Gastrointestinal Agents

Pancrelipase

Pancreatin

Participants will receive E7386 10, 15, 20 mg (milligram) or more, tablets, orally, twice daily, in 28-days treatment cycle until disease progression (PD), development of unacceptable toxicity, participant's 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.

Participants will receive E7386, tablets, orally, twice daily in 28-days treatment cycle until PD, development of unacceptable toxicity, participant's request to discontinue, withdrawal of consent, or termination of the study program. The highest dose of E7386 which is deemed tolerable, or the optimal dose based on PK or PD analysis in dose escalation part will be used for Expansion Part 1.

Participants will receive E7386, tablets, orally, twice daily in 28-days treatment cycle until PD, development of unacceptable toxicity, participant's request to discontinue, withdrawal of consent, or termination of the study program. The dose of Expansion Part 2 will be based on the available safety data from Dose Escalation and Expansion Part 1 of the study.

The primary objective of this study is to assess the safety and tolerability of E7386 in participants with solid tumor including CRC.

The study will be conducted in 3 parts: dose escalation part, expansion part 1 and expansion part 2. The study will include Pre-treatment Phase, Treatment Phase, and Extension Phase (in expansion parts only).

Eligible participants from Pre-Treatment Phase (screening period) will enter into the Treatment Phase to receive E7386. After Treatment Phase, participants will be followed in follow-up period of Extension Phase (in expansion parts only).

A Study of E7386 in Participants With Advanced Solid Tumor Including Colorectal Cancer (CRC)

An Open-label Phase 1 Study of E7386 in Subjects With Advanced Solid Tumor Including Colorectal Cancer

BOR is defined as complete response (CR), partial response (PR), stable disease (SD), PD, and not evaluable (NE), where SD has to be achieved at greater than or equal to (\>=) 7 weeks after the first dose. The BOR will be assessed by investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

The ORR is defined as the percentage of participants with a BOR of CR or PR. The ORR will be assessed by investigator based on RECIST version 1.1.

DCR is defined as the percentage of participants with a BOR of CR, PR, or SD. The DCR will be assessed by investigator based on RECIST version 1.1.

The CBR is defined as the percentage of participants with a BOR of CR, PR, or durable SD (duration of SD \>=23 weeks). The CBR will be assessed by investigator based on RECIST version 1.1.

DOR is defined as the time from the first date of documented CR or PR to the date of PD or death, whichever occurs first. It will be calculated for participants whose BOR is CR or PR. DOR will be assessed according to RECIST version 1.1.

OS is defined as the time from the date of first dose to the date of death.

Eisai Co., Ltd.

Symptoms and General Pathology

Recurrence

E7386 will be administered as a single agent orally, initially twice daily (BID) continuously in 28 days treatment cycle. The dose will be escalated in cohorts of participants subject to safety data and the absence of DLTs. Based on the emerging data after completion of Dose Escalation Part, identifying MTD or RP2D, or after a decision is made to evaluate more than one potential RP2D level, a Dose Expansion Part will be initiated. Participants will continue to receive study treatment in extension phase until disease progression, development of unacceptable toxicity, withdrawal of consent, or termination of the study program.

This study will be conducted to assess the safety/tolerability profile of E7386 as a single agent administered orally in participants with selected advanced or recurrent neoplasms and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of E7386.

Study of E7386 in Participants With Selected Advanced Neoplasms

An Open-Label, Multicenter, Phase 1 Study of E7386 in Subjects With Selected Advanced Neoplasms

DLTs are any of the pre-specified drug-related toxicities (any toxicities considered related to E7386) occurring during Cycle 1 as assessed by the investigator. DLTs will be assessed to determine the maximum tolerated dose.

RP2D will be selected based on an integrated evaluation of safety, tolerability, efficacy, pharmacokinetic (PK) data, and any available pharmacodynamic (PD) data for all dose levels or all available data according to pre-specified guidelines.

ORR is defined as the proportion of participants achieving a best overall response of confirmed partial responses (PR) or complete response (CR), per Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to less than (\<) 10 millimeters (mm). PR is defined as at least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

PFS is defined as the time from the date of the first dose to the date of the first documentation of confirmed disease progression or death, whichever occurs first. Disease progression, per RECIST 1.1, is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Cmax is the maximum plasma concentration of a drug after administration.

tmax is the time to reach maximum concentration following drug administration.

AUC is a measure of actual body exposure to drug after administration of the drug.

t1/2 is the time required for the concentration of the drug to reach half of its original value.

CL/F is the volume of plasma cleared of drug per unit time.

Vd is the apparent volume in which a drug is distributed.

R indicates the extent to which drug accumulates.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of E7386 in Combination With Pembrolizumab in Previously Treated Participants With Selected Solid Tumors	NCT05091346	Melanoma Carcinoma, Hepa... Colorectal Neop...	E7386 Pembrolizumab Lenvatinib	18 Years -	Eisai Inc.
A Study of E7386 in Combination With Other Anticancer Drug in Participants With Solid Tumor	NCT04008797	Neoplasms Carcinoma, Hepa... Liver Neoplasms Colorectal Neop... Endometrial Neo...	E7386 Lenvatinib	18 Years -	Eisai Inc.
A Study of E7386 in Participants With Advanced Solid Tumor Including Colorectal Cancer (CRC)	NCT03833700	Solid Neoplasms Colorectal Neop... Gastrointestina...	E7386	18 Years -	Eisai Inc.
Study of E7386 in Participants With Selected Advanced Neoplasms	NCT03264664	Advanced Neopla...	E7386	18 Years -	Eisai Inc.

Spots Global Cancer Trial Database for e7386

Every month we try and update this database with for e7386 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for e7386

Every month we try and update this database with for e7386 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for e7386 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.