Eisai Clinical Trials
Study Overview
E7080
lenvatinib
NCT01136733, 2010-019484-10
Aug 2010 - Feb 2018
Renal Cell Carcinoma
1. Phase 1b: Number of Participants With Dose-limiting Toxicity (DLT) [Time Frame: First dose of study drug (Cycle 1 Day 1) to end of first 4 weeks of therapy (Cycle 1)]
2. Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 (RP2) Dose [Time Frame: First dose of study drug (Cycle 1 Day 1) to end of Cycle 2 (1 cycle = 28 days/4 weeks)]
3. Phase 2: Progression-Free Survival (PFS) [Time Frame: Date of randomization into Phase 2 (Cycle 1 Day 1) to the date of first documentation of disease progression or death (whichever occurred first), assessed up to data cutoff date (13 Jun 2014), up to approximately 2 years and 3 months]
2. Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 (RP2) Dose [Time Frame: First dose of study drug (Cycle 1 Day 1) to end of Cycle 2 (1 cycle = 28 days/4 weeks)]
3. Phase 2: Progression-Free Survival (PFS) [Time Frame: Date of randomization into Phase 2 (Cycle 1 Day 1) to the date of first documentation of disease progression or death (whichever occurred first), assessed up to data cutoff date (13 Jun 2014), up to approximately 2 years and 3 months]
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Males and females 18 Years to 99 Years (Adult, Older Adult)
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Completed -
Phase 1 / 2
Czechia, Poland, 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 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