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Intraperitoneal Paclitaxel-loaded TPM for Treatment of Peritoneal Carcinomatosis

NCT05159050 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2026-02-25

No results posted yet for this study

Summary

A first-in-human, unblinded, phase I trial of Paclitaxel-loaded tumor penetrating microparticles (TPM) in peritoneal carcinomatosis patients who are not eligible for standard-of-care therapeutic interventions.

Conditions

  • Peritoneal Carcinomatosis

Interventions

DRUG

Paclitaxel-loaded tumor penetrating microparticles

Paclitaxel-loaded TPM, suspended in 0.5 L of 0.1% (w/v) polysorbate 80 in 0.9% sodium chloride is instilled into the peritoneal cavity over 3 to 5 minutes. Mixing of TPM is achieved by putting patient in 5 different positions for about 80 minutes. Dose escalation, the starting dose of TPM is 50 mg/m\^2 paclitaxel-equivalents. Dose escalation will follow the Accelerated Titration Design. The dose levels to which patients will be assigned in sequential cohorts are listed below. Dose escalation schedule of TPM, Dose Level 1\*: 50 mg/m\^2; Dose Level 2: 100 mg/m\^2; Dose Level 3: 135 mg/m\^2; Dose Level 4: 175 mg/m\^2; Dose Level 5: 200 mg/m\^2 \*Starting Dose

Sponsors & Collaborators

  • Institute of Quantitative Systems Pharmacology (IQSP)

    collaborator UNKNOWN

  • Carlos Chan

    lead OTHER

Principal Investigators

  • Carlos Chan, MD, PhD · University of Iowa

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-26
Primary Completion
2024-03-17
Completion
2025-12-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT05159050 on ClinicalTrials.gov