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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: Clinical Trial Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The MTD of PIPAC-MMC will be determined to establish the recommended phase 2 dose (RP2D).
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 |
What is known before NCT07487168 opens enrollment
NCT07487168 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Mitomycin C (MMC) is the first listed.
NCT07487168 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07487168's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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