Your session is about to expire
← Back to Search
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age greater than or equal to 18 years
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 6 years and 10 months
Awards & highlights
Study Summary
This trial is testing a drug to treat advanced/recurrent cancer to find the safest/tolerable dose.
Who is the study for?
Adults with a life expectancy of at least 12 weeks and certain advanced tumors who've recovered from previous cancer treatments can join. They must have an ECOG Performance Status of 0 or 1, indicating they are fully active or restricted in physically strenuous activity but ambulatory. Specific tumor types for different trial parts are required, along with measurable disease, normal organ function, and agreement to vitamin D supplements.Check my eligibility
What is being tested?
The trial is testing the safety and tolerability of E7386, an oral medication for various advanced cancers. It aims to find the highest dose patients can take without serious side effects (MTD) and suggest a Phase 2 dose (RP2D). Participants will be selected based on their type of cancer and health status.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants will be monitored for any adverse reactions to determine the drug's safety profile. Common side effects in trials like this may include nausea, fatigue, diarrhea, risk of infection due to lowered immune response, liver issues, skin reactions among others.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am fully active or can carry out light work.
Select...
My advanced cancer cannot be surgically removed and needs treatment, but there are no standard options left.
Select...
My tumor can be easily reached for a biopsy.
Select...
My cancer can be measured by tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 6 years and 10 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 6 years and 10 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Dose-limiting Toxicities (DLTs)
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Recommended Phase 2 Dose (RP2D)
Secondary outcome measures
Accumulation Ratio (R) of E7386
Apparent Total Body Clearance (CL/F) of E7386
Area Under the Concentration Versus Time Curve (AUC) of E7386
+8 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: E7386 BIDExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
E7386
2019
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Eisai Inc.Lead Sponsor
516 Previous Clinical Trials
158,976 Total Patients Enrolled
22 Trials studying Neoplasms
2,765 Patients Enrolled for Neoplasms
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had any cancer except for certain types in the last 2 years.I have recently undergone treatment for cancer.I am taking medication that affects CYP3A4 enzymes.I have been diagnosed with HIV.I do not have any infections that need treatment.I have had surgery recently.I am not taking any immunosuppressive medications.I am 18 years old or older.I am fully active or can carry out light work.I agree to take vitamin D supplements if needed.I have not used any experimental drugs or live vaccines recently.I have a heart condition that affects my heart's electrical activity.I do not have hepatocellular carcinoma (HCC).My advanced cancer cannot be surgically removed and needs treatment, but there are no standard options left.I cannot take pills or have a stomach condition affecting medication absorption.My tumor can be easily reached for a biopsy.My brain cancer has not caused symptoms and is not getting worse.I have recovered from side effects of my previous cancer treatments.My kidney, liver, bone marrow functions, blood clotting, and electrolyte levels are all within normal ranges.My cancer can be measured by tests.I have specific bone health issues or recent fractures.I have recently undergone radiation therapy.
Research Study Groups:
This trial has the following groups:- Group 1: E7386 BID
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Food & Drug Administration authorized E7386 BID for public use?
"As this is only a Phase 1 trial, with limited evidence for safety and effectiveness, we have estimated the level of security provided by E7386 BID at just 1."
Answered by AI
To what degree is enrollment progressing for this medical study?
"This clinical trial requires 60 eligible participants from two distinct medical centres: USC Norris Comprehensive Cancer Center in Los Angeles, CA and Royal Free London NHS Foundation Trust's Royal Free Hospital located in Rochester, MN."
Answered by AI
In what areas is this investigation available?
"This trial is active in 7 different medical sites located around the world, including USC Norris Comprehensive Cancer Center in Los Angeles, Royal Free London NHS Foundation Trust, Royal Free Hospital in Rochester and The Beatson West of Scotland Cancer Centre."
Answered by AI
Is this research effort accepting new participants?
"Affirmative. The clinical trials page declares that this study is in its active recruitment phase, which began on July 27th 2017 and was recently updated on May 31st 2023. This research seeks 60 participants from 7 distinct medical facilities."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger