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NCT07487168 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of PIPAC Using Single Agent Mitomycin in Solid Tumors
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Not yet
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT07487168 is a Phase 1 study that has not yet begun recruiting, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 24 participants.
The verdict
NCT07487168, a Phase 1 study, has not yet begun recruiting, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This single-center, Phase 1 dose-escalation study will evaluate the safety, tolerability, and recommended Phase 2 dose (RP2D) of pressurized intraperitoneal aerosol chemotherapy with mitomycin C (PIPAC-MMC) for patients with unresectable peritoneal carcinomatosis from gastrointestinal primaries (colorectal, high-grade appendiceal, or small bowel). Up to three PIPAC procedures are planned at 8-week intervals while patients continue 5-fluorouracil/leucovorin (5-FU/LV) between procedures. The trial uses a Bayesian optimal interval (BOIN) design to determine dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD). Pharmacokinetics (PK), pharmacodynamics (PD), and quality of life (QoL) will be assessed.
Interventions
- DRUG Mitomycin C (MMC)
- DEVICE Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2026-08 |
| Est. Completion | 2028-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07487168
The ClinicalTrials.gov registry entry for NCT07487168 describes a study currently listed as not yet recruiting, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Mitomycin C (MMC) is the first listed.
NCT07487168 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07487168 about?
NCT07487168 is a clinical study titled "Safety and Efficacy of PIPAC Using Single Agent Mitomycin in Solid Tumors". This single-center, Phase 1 dose-escalation study will evaluate the safety, tolerability, and recommended Phase 2 dose (RP2D) of pressurized intraperitoneal aerosol chemotherapy with mitomycin C (PIPAC-MMC) for patients with unresectable peritoneal carcinomatosis from gastrointestinal primaries (col...
What is the current status of trial NCT07487168?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2026-08. Estimated completion is 2028-03.
What interventions are being tested in trial NCT07487168?
The interventions under investigation include: Mitomycin C (MMC) (DRUG), Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) (DEVICE).
Who is sponsoring clinical trial NCT07487168?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
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