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2019-03-05
2026-01-31
2026-01-31
70
NCT03833700
Eisai Inc.
Eisai Inc.
INTERVENTIONAL
A Study of E7386 in Participants With Advanced Solid Tumor Including Colorectal Cancer (CRC)
This study will be conducted 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 consist of Primary Assessment Phase and Continuation Phase. Primary Assessment Phase will include Pre-treatment Phase, Treatment Phase and Extension Phase (in expansion parts only). After Treatment Phase, participants will be followed in follow-up period of Extension Phase (in expansion parts only). All participants who are still on study drug at the time of data cutoff date for the planned primary analysis will enter the Continuation phase and continue to receive E7386.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2019-02-06 | N/A | 2025-01-13 |
2019-02-06 | N/A | 2025-01-15 |
2019-02-07 | N/A | 2025-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Sequential
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Dose Escalation Part: E7386 Participants will receive E7386 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. | DRUG: E7386
|
| EXPERIMENTAL: Expansion Part 1 Participants will receive E7386 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. | DRUG: E7386
|
| EXPERIMENTAL: Expansion Part 2 Participants will receive E7386 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. | DRUG: E7386
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of Participants with Dose-limiting Toxicities (DLTs) | 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). | Baseline up to Cycle 1 (Cycle length is equal to [=] 28 days) |
| Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 30 days after the last dose of study drug or before initiating post anti-cancer treatment (approximately 6 years) |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Cmax: Maximum Observed Plasma Concentration for E7386 | Dose escalation Part, Cycles 1 to 6: Up to Day 8; Dose Expansion Part 1 and 2, Cycles 1 and 2: Up to Day 8 (Cycle length=28 days) | |
| Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E7386 | Dose escalation Part, Cycles 1 to 6: Up to Day 8; Dose Expansion Part 1 and 2, Cycles 1 and 2: Up to Day 8 (Cycle length=28 days) | |
| AUC: Area Under the Plasma Concentration Versus Time Curve for E7386 | Dose escalation Part, Cycles 1 to 6: Up to Day 8; Dose Expansion Part 1 and 2, Cycles 1 and 2: Up to Day 8 (Cycle length=28 days) | |
| CL/F: Apparent Total Body Clearance for E7386 | Dose escalation Part, Cycles 1 to 6: Up to Day 8; Dose Expansion Part 1 and 2, Cycles 1 and 2: Up to Day 8 (Cycle length=28 days) | |
| Vz/F: Apparent Volume of Distribution for E7386 | Dose escalation Part, Cycles 1 to 6: Up to Day 8; Dose Expansion Part 1 and 2, Cycles 1 and 2: Up to Day 8 (Cycle length=28 days) | |
| Objective Response Rate (ORR) | The ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). The ORR will be assessed by investigator based on RECIST version 1.1. | From first dose of study drug until PD, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 6 years) |
| Disease Control Rate (DCR) | DCR is defined as the percentage of participants with a BOR of CR, PR, or stable disease (SD). The DCR will be assessed by investigator based on RECIST version 1.1. | From first dose of study drug until PD, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 6 years) |
| Clinical Benefit Rate (CBR) | The CBR is defined as the percentage of participants with a BOR of CR, PR, or durable SD. The CBR will be assessed by investigator based on RECIST version 1.1. | From first dose of study drug until PD, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 6 years) |
| Progression-free Survival (PFS) | 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. | From first dose of study drug until PD, or death from any cause, whichever occurs first (up to approximately 6 years) |
| Duration of Response (DOR) | 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. | From the date of first documented CR or PR until first documentation of PD or death (up to approximately 6 years) |
| Overall Survival (OS) | OS is defined as the time from the date of first dose to the date of death. | From first dose of study drug until date of death (up to approximately 6 years) |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
