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

NCT03348514 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2021-12-03

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Cmed Clinical Services

    collaborator OTHER

  • CicloMed LLC

    lead INDUSTRY

Principal Investigators

  • John A Taylor III, MD, MSc · University of Kansas Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-15
Primary Completion
2020-05-31
Completion
2020-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03348514 on ClinicalTrials.gov