Clinical Trials
Multiple Phase 1, Phase 1/2, and Phase 2 clinical trials, primarily sponsored by industry entities including Eisai and Merck Sharp & Dohme, evaluate the therapeutic profile, pharmacokinetics, and clinical utility of E7386. These investigations focus on advanced solid neoplasms—such as colorectal cancer, hepatocellular carcinoma, melanoma, and endometrial neoplasms—alongside pharmacokinetic studies in healthy volunteers. Protocol statuses across these monotherapy and combination therapy evaluations range from active and completed to withdrawn.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT03264664 | ACTIVE_NOT_RECRUITING | Advanced Neoplasms |
Eisai Inc. |
2017-07-27 | PHASE1 |
| NCT04008797 | ACTIVE_NOT_RECRUITING | Endometrial Neoplasms; Neoplasms; Carcinoma, Hepatocellular; Liver Neoplasms; Colorectal Neoplasms |
Eisai Inc. |
2019-07-11 | PHASE1; PHASE2 |
| NCT03833700 | ACTIVE_NOT_RECRUITING | Solid Neoplasms; Colorectal Neoplasms; Gastrointestinal Tumors |
Eisai Co., Ltd. |
2019-03-05 | PHASE1 |
| NCT05091346 | COMPLETED | Melanoma; Carcinoma, Hepatocellular; Colorectal Neoplasms |
Eisai Inc. |
2021-10-27 | PHASE1; PHASE2 |
| NCT05607537 | COMPLETED | Healthy Volunteers |
Eisai Limited |
2022-10-17 | PHASE1 |
| NCT04840927 | WITHDRAWN | Healthy Volunteers |
Eisai Limited |
2021-04-09 | PHASE1 |
| NCT05607537 | Completed | Healthy Volunteers |
Eisai Limited|Eisai Inc. |
2022-10-17 | Phase 1 |
| NCT05091346 | Recruiting | Melanoma|Carcinoma Hepatocellular|Colorectal Neoplasms |
Eisai Inc.|Merck Sharp & Dohme LLC |
2021-10-27 | Phase 1|Phase 2 |
| NCT04840927 | Withdrawn | Healthy Volunteers |
Eisai Limited|Eisai Inc. |
2021-04-09 | Phase 1 |
| NCT03996226 | COMPLETED | Food Effect in Healthy Participants |
Eisai Inc. |
2019-06-07 | PHASE1 |
| NCT04008797 | Recruiting | Neoplasms|Carcinoma Hepatocellular|Liver Neoplasms|Colorectal Neoplasms|Endometrial Neoplasms |
Eisai Inc. |
2019-07-11 | Phase 1 |
| NCT03996226 | Completed | Food Effect in Healthy Participants |
Eisai Inc. |
2019-06-07 | Phase 1 |
| NCT03833700 | Active not recruiting | Solid Neoplasms|Colorectal Neoplasms|Gastrointestinal Tumors |
Eisai Co. Ltd.|Eisai Inc. |
2019-03-05 | Phase 1 |
(data from https://clinicaltrials.gov, updated on 2026-06-08)
Compliance for Clinical Use
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).