Eisai Clinical Trials
Study Overview
E7386
N/A
NCT04008797, 2022-003300-32, 2023-510275-64
Jul 2019 -
Solid Tumors
1. Dose Escalation Part: Number of Participants with Dose-limiting Toxicities (DLTs) [Time Frame: 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) [Time Frame: 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 [Time Frame: 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)]
2. Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: 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 [Time Frame: 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)]
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Males and females 18 Years and older (Adult, Older Adult)
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Ongoing -
Phase 1 / 2
Canada, China, Denmark, France, Italy, Japan, Korea, Republic of, Spain, Taiwan, United States See moreData Sharing
ClinicalStudyDataRequest.com (CSDR) is a multi sponsor site through which qualified researchers who wish to access clinical trial data and associated information in order to conduct further research can submit their research proposal or enquiry.
CSDR Sharing is not available for this study.
CSDR Availability Clinical Trial Data Redacted documents may be available upon request for this study.
Document type Availability Protocol SAP Sample CRF Full CSR