Spots Global Cancer Trial Database for Study of E7046 in Subjects With Selected Advanced Malignancies

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Trial Identification

Brief Title: Study of E7046 in Subjects With Selected Advanced Malignancies

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

Study ID: NCT02540291

Conditions

Tumors

Interventions

E7046

Study Description

Brief 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.