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Clinical Trial Summary

This is an open label, multicenter, Phase 1 study of E7046 to assess the safety and tolerability of E7046 and to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of E7046.


Clinical Trial Description

The study will be conducted in 2 parts: a dose escalation part to determine the MTD and/or RP2D of E7046, and a cohort expansion part with 6 to 16 participants to better characterize safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) at the RP2D. In the dose escalation part, increasing doses of E7046 will be administered to cohorts of 6 participants, at dose levels ranging from 125 mg to 750 mg. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02540291
Study type Interventional
Source Eisai Inc.
Contact
Status Terminated
Phase Phase 1
Start date July 30, 2015
Completion date February 27, 2018

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