drugset / Trial / NCT02118285
Intraperitoneal Natural Killer Cells and INCB024360 for Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
Phase 1
Completed
2 enrolled
Masonic Cancer Center, University of Minnesota
Incyte Corporation · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2014-07-28
- Primary completion
- 2015-11-12
- Completion
- 2015-11-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Epacadostat | Small molecule | 25 mg | Oral |
| Subject | Epacadostat | Small molecule | 50 mg | Oral |
| Subject | Epacadostat | Small molecule | 100 mg | Oral |
| Subject | Epacadostat | Small molecule | 200 mg | Oral |
| Subject | Epacadostat | Small molecule | 300 mg | Oral |
| Background | Cyclophosphamide | Other / unclassified | 30 mg/kg | Intravenous |
| Background | Fludarabine | Small molecule | 25 mg/m2 | Intravenous |
| Background | TROCULEUCEL | Cell therapy | — | Other |
| Background | aldesleukin | Protein / enzyme biologic | 6e+06 iu | Other |