Eisai Clinical Trials
Study Overview
E7386
E7386
NCT05091346, 2023-505425-14, 2021-001568-10, jRCT2031210405
Oct 2021 - Oct 2024
Solid Tumors
1. Phase 1b Part: Number of Participants With Dose-limiting Toxicities (DLTs) [Time Frame: Cycle 1 (Cycle length is equal to [=] 21 days)]
2. Phase 1b Part: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Time Frame: From date of first dose of study drug up to 30 days after last administration of study drug (approximately up to 3 years 11 months)]
3. Phase 2 Part: Objective Response Rate (ORR) [Time Frame: From first dose of study drug until progressive disease (PD) or death, development of unacceptable toxicity, withdrawal of consent, or study termination (up to approximately 3 years 11 months)]
2. Phase 1b Part: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Time Frame: From date of first dose of study drug up to 30 days after last administration of study drug (approximately up to 3 years 11 months)]
3. Phase 2 Part: Objective Response Rate (ORR) [Time Frame: From first dose of study drug until progressive disease (PD) or death, development of unacceptable toxicity, withdrawal of consent, or study termination (up to approximately 3 years 11 months)]
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Males and females 18 Years and older (Adult, Older Adult)
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Completed -
Phase 1 / 2
Japan, Spain, United Kingdom, 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