Last updated on July 2020

Safety Dose Tolerance Pharmacokinetics and Pharmacodynamics Study of CPX-POM in Patients With Advanced Solid Tumors

Brief description of study

This is a first-in-human, Phase I, multicenter, open label, dose escalation study to evaluate the DLTs and MTD and to determine the recommended Phase 2 dose (RP2D) of CPX-POM administered IV in patients with any histologically- or cytologically-confirmed solid tumor type.

Detailed Study Description

The study will initially employ an accelerated escalation design, with a single patient enrolled in each cohort (i.e., Single-Patient Cohorts). The initial patient will receive CPX-POM at a starting dose of 30 mg/m2. Doses will be escalated (doubling), until a Grade 2 toxicity (with the exception of alopecia), is encountered. Subsequently that and all subsequent cohorts will follow a classical "3 + 3" dose escalation design.

Clinical Study Identifier: NCT03348514

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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