JPRN-jRCT2080224780
Recruiting
Phase 1
An Open-Label Phase 1b Study of E7386 in CombinationWith Other Anticancer Drug(s) in Subjects With SolidTumors
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Hepatocellular carcinoma (HCC), Solid tumor (ST), Colorectal cancer (CRC), Endometrial cancer(EC)
- Sponsor
- Eisai Co., Ltd.
- Enrollment
- 181
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. HCC part only:
- •Participants with confirmed diagnosis of unresectable HCC with any of the following criteria:
- •a. Histologically or cytologically confirmed diagnosis of HCC, excluding fibrolamellar, sarcomatoid or mixed cholangio\-HCC tumors
- •b. Clinically confirmed diagnosis of HCC according to American Association for the Study of Liver Diseases (AASLD) criteria, including cirrhosis of any etiology and/or chronic hepatitis B or C infection
- •ST part only (except for HCC):Participants with histologically or cytologically confirmed diagnosis of solid tumor for which no alternative standard therapy or no effective therapy exists
- •2\. Life expectancy of \>\=12 weeks
- •3\. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
- •4\. All AEs due to previous anti\-cancer therapy have either returned to Grade 0 to 1 except for alopecia or up to Grade 2 peripheral neuropathy (renal/bone marrow/liver function should meet the inclusion criteria)
- •5\. Adequate washout period before study drug administration:
- •a. Chemotherapy and radiotherapy: 3 weeks or 5 times the half\-life, whichever is shorter
Exclusion Criteria
- •1\. Any of cardiac conditions as follows:
- •a. Heart failure New York Heart Association (NYHA) Class II or above
- •b. Unstable ischaemic heart disease (myocardial infarction within 6 months prior to starting study drug, or angina requiring use of nitrates more than once weekly)
- •c. Prolongation of QT interval with Fridericias correction (QTcF) to greater than (\>) 480 millisecond (msec)
- •d. Left ventricular ejection fraction (LVEF) less than 50 percent (%)
- •2\. Major surgery within 21 days or minor surgery (that is, simple excision) within 7 days prior to starting study drug. Participant must have recovered from the surgery related toxicities to less than Grade 2\.
- •Note: Adequate wound healing after major surgery must be assessed clinically, independent of time elapsed for eligibility
- •3\. Known to be human immunodeficiency virus (HIV) positive Note: the sponsor has evaluated whether to include participant with HIV. Given that this is the first combination study of E7386 with lenvatinib and that the main mechanism of action of E7386 is immunomodulation of the tumor microenvironment along with the fact that several anti\-retroviral therapies have drug\-drug interaction with cytochrome P450 3A (CYP3A) substrates, the sponsor has decided not to include these participants at the current time. However, further considerations will be made moving forward based on new emerging data Note: HIV testing is required at screening only when mandated by local health authority
- •4\. Participants with proteinuria \>1 positive on urine dipstick testing will undergo 24\-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein \>\=1 gram per 24 hour will be ineligible
- •5\. Active infection requiring systemic treatment (Except for Hepatitis B and/or C \[HBV/HCV] infection in HCC participants)
Outcomes
Primary Outcomes
Not specified
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