drugset / Trial / NCT02640365
A Dose Escalation Study of MM-398 Plus Irinotecan in Patients With Unresectable Advanced Cancer
Phase 1
Completed
10 enrolled
GERCOR - Multidisciplinary Oncology Cooperative Group
Merrimack Pharmaceuticals · collab
NaSingle-groupOpen-labelTreatment
Summary
MM-398 (also known as PEP02) is nanoliposomal encapsulated irinotecan: the liposomal formulation is designed to extend plasma circulation and to increase accumulation in the tumor through the enhanced permeability and retention (EPR) effect. This study introduces a new concept of combining free and nanoliposomal drugs.
Timeline
- Start
- 2015-11-18
- Primary completion
- 2016-12-07
- Completion
- 2016-12-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan | Small molecule | 90 mg/m2 | — |
| Subject | Irinotecan | Small molecule | 120 mg/m2 | — |
| Subject | Irinotecan Sucrosofate | Other / unclassified | 60 mg/m2 | — |
| Subject | Irinotecan Sucrosofate | Other / unclassified | 80 mg/m2 | — |
| Background | Bevacizumab | Monoclonal antibody | 5 mg/kg | — |
| Background | Leucovorin | Small molecule | 400 mg/m2 | — |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | — |
Indications
No indication recorded.