A Study of E7386 in Combination With Other Anticancer Drug in Participants With Solid Tumor

• Status: Recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eisai Inc.
• Treatments: Lenvatinib

Criteria

Inclusion Criteria:

1. HCC part only:

Participants with confirmed diagnosis of unresectable HCC with any of the following criteria:

1. Histologically or cytologically confirmed diagnosis of HCC, excluding fibrolamellar, sarcomatoid or mixed cholangio-HCC tumors

2. 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 (renal/bone marrow/liver function should meet the inclusion criteria).

5. Adequate controlled blood pressure (BP), renal function, bone marrow function, liver function, and serum mineral level

6. At least one measurable lesion based on mRECIST (HCC parts) or on RECIST 1.1 (ST-parts)

7. HCC parts only: Child-Pugh score A

8. HCC parts only: Participants categorized to stage B (not applicable for trans arterial chemoembolization), or stage C based on Barcelona Clinic Liver Cancer (BCLC) staging system

Exclusion Criteria:

1. Any of cardiac conditions as follows:

1. Heart failure New York Heart Association (NYHA) Class II or above

2. Unstable ischaemic heart disease (myocardial infarction within 6 months prior to starting study drug, or angina requiring use of nitrates more than once weekly)

3. Prolongation of QT interval with Fridericias correction (QTcF) to greater than (>) 480 millisecond (msec)

4. Left ventricular ejection fraction (LVEF) less than 50 percent (%)

2. Known to be human immunodeficiency virus (HIV) positive

3. 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

4. Diagnosed with meningeal carcinomatosis

5. Participants with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (example, radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment

6. Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen

7. Bleeding or thrombotic disorders or use of anticoagulants requiring therapeutic International Normalized Ratio (INR) monitoring (example, warfarin or similar agents)

8. Gastrointestinal bleeding event or active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug