Active — Not RecruitingPhase 1

A Study of E7386 in Participants With Advanced Solid Tumor Including Colorectal Cancer (CRC)

Japan70 participantsStarted 2019-03-05

Plain-language summary

This study will be conducted to assess the safety and tolerability of E7386 in participants with solid tumor including CRC.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Participants with a histological and/or cytological diagnosis of solid tumor must have any of the following tumor types:
✓. Dose Escalation Part: Participants with advanced, unresectable, or recurrent solid tumor including CRC for which no alternative standard therapy or no effective therapy exists
✓. Expansion Part 1: Participants with advanced, unresectable, or recurrent CRC in third- or later-line, Or participants with other gastrointestinal tumors such as small bowel carcinoma and gastrointestinal neuroendocrine tumors after at least 1 prior systemic chemotherapy regimen upon discussion and agreement with the sponsor
✓. Expansion Part 2: Participants with advanced, unresectable, or recurrent solid tumors expected to be highly dependent on wingless/integrated (Wnt)/β-catenin signaling pathway as specified below, who have no standard therapy. Disease progression must be confirmed within the past 12 months.
✓. A diagnosis of HCC that is histologically or cytologically confirmed (excluding fibrolamellar, sarcomatoid or mixed cholangio-HCC tumors) or clinically confirmed according to American Association for the Study of Liver Disease criteria, including cirrhosis of any etiology and/or chronic hepatitis B or C infection.
✓. Barcelona Clinic Liver Cancer (BCLC) Stage C disease, or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy, and not amenable to a curative treatment approach
✓. Life expectancy of \>=12 weeks.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.

Exclusion criteria

✕. Known to be human immunodeficiency virus (HIV) positive.
✕. Active infection requiring systemic treatment.
✕. Antiviral therapy for Hepatitis B virus (HBV) is not ongoing
✕. HBV viral load is 2000 International units per milliliter (IU/mL) or more at the Screening Period although antiviral therapy for HBV is ongoing
✕. Has dual active HBV infection (HBsAg \[+\] and/or detectable HBV Deoxyribonucleic acid \[DNA\]) and Hepatitis C virus (HCV) infection (anti-HCV Ab \[+\] and detectable HCV Ribonucleic acid \[RNA\]) at study entry
✕. Diagnosed with meningeal carcinomatosis.
✕. 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.
✕. Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.

What they're measuring

Number of Participants with Dose-limiting Toxicities (DLTs)

Timeframe: Baseline up to Cycle 1 (Cycle length is equal to [=] 28 days)

Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: Up to 30 days after the last dose of study drug or before initiating post anti-cancer treatment (approximately 6 years)

Trial details

NCT IDNCT03833700

SponsorEisai Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03-31

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