NCT05159050

Intraperitoneal Paclitaxel-loaded TPM for Treatment of Peritoneal Carcinomatosis

Phase I Trial of Intraperitoneal Paclitaxel-loaded Tumor Penetrating Microparticles (TPM) for Treatment of Peritoneal Carcinomatosis

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Carlos Chan · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a first in human study of Paclitaxel-loaded TPM, suspended in 0.5 L of 0.1% polysorbate 80 in normal saline instilled into the peritoneal cavity. An enrolled patient will (a) undergo laparoscopy during which time the hydrostatic pressures at different locations within the peritoneal cavity are measured, pretreatment tumors are biopsied and peritoneal catheter is placed, (b) receive intraperitoneal TPM during index hospital stay, and (c) followed-up to evaluate treatment-related toxicity and response. The pharmacokinetics of TPM and paclitaxel in peritoneal fluid and systemic blood samples will be measured. Second dose of TPM is given in clinic if no disease progression or significant AEs. This is a dose escalation study. Dose escalation will proceed using an accelerated titration design (ATD) with intra-patient dose escalation. In the event either: * 1 patient exhibits DLT during the first course of treatment or * 2 patients exhibit grade 2 study drug-related (attribution of probable or definite) toxicity during the first course of treatment. The design switches to a standard 3+3 design at the dose that triggered the switch-two additional patients are accrued at this dose level. Decisions on when and how to escalate if the design switches to a 3+3 are described in the protocol section 6.3

Conditions

• Peritoneal Carcinomatosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-04-26
• Primary completion: 2024-03-17
• Completion: 2025-12-09
• First posted: 2021-12-15
• Last updated: 2026-02-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study