A Study of E7386 in Combination With Other Anticancer Drug(s) in Participants With Solid Tumor (NCT04008797) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Study of E7386 in Combination With Other Anticancer Drug(s) in Participants With Solid Tumor
United States301 participantsStarted 2019-07-11
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. HCC part only:
✓. Histologically or cytologically confirmed diagnosis of HCC, excluding fibrolamellar, sarcomatoid or mixed cholangio-HCC tumors
✓. 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
✓. Life expectancy of \>=12 weeks
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
✓. 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)
✓. Adequate washout period before study drug administration:
✓. Chemotherapy and radiotherapy: 3 weeks or 5 times the half-life, whichever is shorter
Exclusion criteria
✕. Any of cardiac conditions as follows:
✕. 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
✕. 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
What they're measuring
1
Dose Escalation Part: Number of Participants with Dose-limiting Toxicities (DLTs)
Timeframe: Cycle 0 (Cycle 0 length=6 or 7 days) up to Cycle 1 (Cycle 1 length=28 days)
2
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 (up to approximately 90 months)
3
Dose Optimization Part: Objective Response Rate (ORR) per RECIST 1.1 by Investigator Assessment
Timeframe: From first dose of study drug until PD, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 90 months)
✕. Participants with proteinuria 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
✕. Active infection requiring systemic treatment (Except for Hepatitis B and/or C \[HBV/HCV\] infection in HCC participants)
✕. Diagnosed with meningeal carcinomatosis
✕. Participants with central nervous system metastases are only eligible if they have been previously treated and are radiologically stable, (that is, without evidence of progression for at least 4 weeks prior to first dose of study treatment by repeat imaging), clinically stable, and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment
✕. Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen