TerminatedPhase 1

Intraperitoneal Paclitaxel-loaded TPM for Treatment of Peritoneal Carcinomatosis

Stopped: Drug supply issues

United States4 participantsStarted 2022-04-26

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 10 months beyond the last dose of TPM. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
✓. A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

What they're measuring

Assess safety of intraperitoneal Paclitaxel-loaded Tumor Penetrating Microparticles (TPM)

Timeframe: 12 Weeks

Determine the maximum tolerated dose (MTD) of intraperitoneal Paclitaxel-loaded Tumor Penetrating Microparticles (TPM)

Timeframe: 4 Weeks

Trial details

NCT IDNCT05159050

SponsorCarlos Chan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-17

View on ClinicalTrials.gov More Peritoneal Carcinomatosis trials