Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04008797 · ClinicalTrials.gov registry record · Phase 1
A Study of E7386 in Combination With Other Anticancer Drug(s) in Participants With Solid Tumor
A Phase 1 study of Neoplasms and Colorectal Neoplasms, sponsored by Eisai.
- Active
- Registry status
- Phase 1
- Development phase
- 301
- Enrollment target
- 20
- Study locations
NCT04008797: Active Phase 1 study of Neoplasms and Colorectal Neoplasms, sponsored by Eisai.
NCT04008797 is a Phase 1 study of Neoplasms and Colorectal Neoplasms that is active but no longer recruiting, run by Eisai. The registered enrollment target is 301 participants, below the 1,619-participant average among 158 other Neoplasms trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04008797, a Phase 1 study of Neoplasms and Colorectal Neoplasms, is active but no longer recruiting, sponsored by Eisai.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 301 participants
- Enrollment target
- 20
- Study locations
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), and to determine the optimal dose of E7386 in combination with lenvatinib in endometrial carcinoma (EC) (for EC Dose Optimization Part only).
Primary Outcome
DLTs 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).
Conditions Studied
Interventions
- DRUG Doxorubicin
- DRUG Paclitaxel
- DRUG Lenvatinib
- DRUG E7386
Study Locations (20)
California
- University of California San Diego (UCSD) - Moores Cancer Center(All) - La Jolla
- Cedars-Sinai Medical Center - Los Angeles
- Pasadena Liver Center - Pasadena
- California Pacific Medical Center - San Francisco
- UCLA University of California - Los Angeles - Santa Monica
- John Muir Clinical Research - Walnut Creek
Florida
- Uni. Of Miami- Sylvester Cancer Centre - Miami
- Florida Cancer Specialists - South - Sarasota
- Florida Cancer Specialists - East - West Palm Beach
New York
- Perlmutter Cancer Center- NYU Langone Health - New York
- Memorial Sloan Kettering Cancer Center - New York
- Montefiore Medical Center (MMC) - Jack D. Weiler Hospital - The Bronx
Ohio
- MetroHealth Medical Center - Cleveland
- ProMedica Flower Hospital - Sylvania
Arkansas
- UAMS - Little Rock
Colorado
- University of Colorado Cancer Center - Anschutz Medical Campus - Aurora
Louisiana
- Women's Cancer Care - Covington, LA - Covington
Mississippi
- University Of Mississippi Medical Center - Jackson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 301 participants |
| Start Date | 2019-07-11 |
| Est. Completion | 2027-03-31 |
| Phase | Phase 1 |
What the registry record for NCT04008797 still lists
NCT04008797 is an interventional study that assigns participants to a tested intervention. The registered 301 participants enrollment target is mid-sized for trials with a published cap, below the 1,619-participant average among 158 other Neoplasms trials with a reported enrollment target (81% lower).
The record links to 5 conditions, with Neoplasms appearing as the primary indexed condition, and to 4 interventions - of which Doxorubicin is the first listed.
NCT04008797 names 20 study sites across 10 states, led by California, Florida, New York.
Frequently Asked Questions
What is clinical trial NCT04008797 about?
NCT04008797 is a clinical study titled "A Study of E7386 in Combination With Other Anticancer Drug(s) in Participants With Solid Tumor". 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), and to determine the optimal dose of E7386 in combination with lenvatinib in endometrial carcinoma (EC) (for EC Dos...
What is the current status of trial NCT04008797?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 301 participants. The study started on 2019-07-11. Estimated completion is 2027-03-31.
What conditions does trial NCT04008797 study?
This clinical trial studies the following conditions: Neoplasms, Colorectal Neoplasms, Carcinoma, Hepatocellular, Endometrial Neoplasms, Liver Neoplasms.
What interventions are being tested in trial NCT04008797?
The interventions under investigation include: Doxorubicin (DRUG), Paclitaxel (DRUG), Lenvatinib (DRUG), E7386 (DRUG).
Who is sponsoring clinical trial NCT04008797?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04008797 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Florida, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neoplasms
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04008797's enrollment target sits among peer trials
301 32nd of 158 higher than 127 of 158 other Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Clinical Activity of RO7673396 in Participants With Advanced Solid Tumors Harboring Rat Sarcoma Viral Oncogene Homolog (RAS) Mutation(s)
RECRUITING · Phase 1
-
A Study of GSK5764227 in Participants With. Advanced Solid Tumors (EMBOLD PanTumor-101)
RECRUITING · Phase 1
-
Adoptive Cell Therapy Long-term Follow-up (LTFU) Study
RECRUITING · Phase 1
-
Two Part Study of Nenocorilant Combined With Nivolumab in Patients With Advanced Solid Malignancies
RECRUITING · Phase 1
-
EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers
RECRUITING · Phase 1
-
Open-Label Study of Pocenbrodib Alone and in Combination With Abiraterone Acetate, Olaparib, or 177Lu-PSMA-617
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05005975 · 301 participants · Phase 3
Extension Study to Evaluate Safety and Tolerability of Oral Dersimelagon (MT-7117) in Subjects With Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)
- NCT05722561 · 302 participants · Phase 2
E-Cigarettes for Harm Reduction in Smokers With Opioid Use Disorder
- NCT06015737 · 302 participants · Phase 3
A Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus
- NCT07176273 · 302 participants · NA
Adaptive Decision-making And Personalized Treatment for PTSD (ADAPT-PTSD)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI