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NCT02118285 · ClinicalTrials.gov registry record · Phase 1

Intraperitoneal Natural Killer Cells and INCB024360 for Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

A Phase 1 study, sponsored by Masonic Cancer Center, University of Minnesota.

Completed
Registry status
Phase 1
Development phase
2
Enrollment target

NCT02118285: Completed Phase 1 study, sponsored by Masonic Cancer Center, University of Minnesota.

NCT02118285 is a Phase 1 study that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02118285, a Phase 1 study, has completed, sponsored by Masonic Cancer Center, University of Minnesota.

COMPLETED
Registry status
Phase 1
Development phase
2 participants
Enrollment target

Study Summary

This is a single center phase I trial designed to determine the maximum tolerated dose (MTD) of the oral IDO inhibitor INCB024360 when administered as part of a larger regimen of intraperitoneal (IP) delivery of haploidentical donor NK cells and IL-2 after a non-myeloablative cyclophosphamide/fludarabine (Cy/Flu) preparative regimen for the treatment of recurrent ovarian, fallopian tube, and primary peritoneal cancer.

Primary Outcome

To determine the maximum tolerated dose (MTD) of INCB024360 when administered with intraperitoneal haploidentical donor NK cells/IL-2 after a nonmyeloablative cyclophosphamide/fludarabine (Cy/Flu) preparative regimen in patients with recurrent ovarian, fallopian tube, and primary peritoneal cancer

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • BIOLOGICAL NK cells
  • BIOLOGICAL IL-2
  • DRUG INCB024360

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2014-07-28
Est. Completion 2015-11-12
Phase Phase 1

What the finished NCT02118285 record still lists

NCT02118285 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT02118285 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02118285 about?

NCT02118285 is a clinical study titled "Intraperitoneal Natural Killer Cells and INCB024360 for Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer". This is a single center phase I trial designed to determine the maximum tolerated dose (MTD) of the oral IDO inhibitor INCB024360 when administered as part of a larger regimen of intraperitoneal (IP) delivery of haploidentical donor NK cells and IL-2 after a non-myeloablative cyclophosphamide/fludar...

What is the current status of trial NCT02118285?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2014-07-28. Estimated completion is 2015-11-12.

What interventions are being tested in trial NCT02118285?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), NK cells (BIOLOGICAL), IL-2 (BIOLOGICAL), INCB024360 (DRUG).

Who is sponsoring clinical trial NCT02118285?

This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02118285's enrollment target sits among peer trials

2 2000th of 2000 the lowest 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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Source: ClinicalTrials.gov NCT02118285, the US trial registry maintained by the National Library of Medicine. NCT02118285 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.