NCT03348514

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

A Phase 1, First-in-Human, Safety, Dose Tolerance, Pharmacokinetics, and Pharmacodynamics Study of CPX-POM in Patients With Advanced Solid Tumors.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: CicloMed LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 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. Note: Fosciclopirox is the generic name for CPX-POM.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	CPX-POM - 30 mg/m^2	CPX-POM
DRUG	CPX-POM - 60 mg/m^2	CPX-POM
DRUG	CPX-POM - 120 mg/m^2	CPX-POM
DRUG	CPX-POM - 240 mg/m^2	CPX-POM
DRUG	CPX-POM - 360 mg/m^2	CPX-POM
DRUG	CPX-POM - 600 mg/m^2	CPX-POM
DRUG	CPX-POM - 900 mg/m^2	CPX-POM
DRUG	CPX-POM - 1200 mg/m^2	CPX-POM

Timeline

• Start date: 2018-01-15
• Primary completion: 2020-05-31
• Completion: 2020-05-31
• First posted: 2017-11-21
• Last updated: 2021-12-03
• Results posted: 2021-11-17

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study