NCT02540291

Study of E7046 in Subjects With Selected Advanced Malignancies

An Open-Label Multicenter Phase 1 Study of E7046 in Subjects With Selected Advanced Malignancies

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Tumors

Interventions

Type	Name	Description
DRUG	E7046	E7046 will be administered as a single agent orally once daily (QD) continuously in 21-day cycles. In the dose escalation part, increasing doses of E7046 ranging from 125 mg to 750 mg will be administered to cohorts of 6 participants. In the cohort expansion part, participants will be treated at the RP2D.

Timeline

• Start date: 2015-07-30
• Primary completion: 2018-02-27
• Completion: 2018-02-27
• First posted: 2015-09-03
• Last updated: 2020-02-17
• Results posted: 2020-02-17

Locations

3 sites across 2 countries: United States, France