drugset / Trial / NCT01770353
MM-398 (Nanoliposomal Irinotecan, Nal-IRI) to Determine Tumor Drug Levels and to Evaluate the Feasibility of Ferumoxytol Magnetic Resonance Imaging to Measure Tumor Associated Macrophages and to Predict Patient Response to Treatment
Non-randomizedSingle-groupOpen-labelOther
Summary
This is a Phase I study to understand the biodistribution of MM-398 and to determine the feasibility of using Ferumoxytol as a tumor imaging agent.
Timeline
- Start
- 2012-11
- Primary completion
- 2018-10-02
- Completion
- 2018-10-02
Publications
- Ravi H, Arias-Lorza AM, Costello JR, Han HS, Jeong DK, Klinz SG, Sachdev JC, Korn RL, Raghunand N. Pretherapy Ferumoxytol-enhanced MRI to Predict Response to Liposomal Irinotecan in Metastatic Breast Cancer. Radiol Imaging Cancer. 2023 Mar;5(2):e220022. doi: 10.1148/rycan.220022.
- Sachdev JC, Munster P, Northfelt DW, Han HS, Ma C, Maxwell F, Wang T, Belanger B, Zhang B, Moore Y, Thiagalingam A, Anders C. Phase I study of liposomal irinotecan in patients with metastatic breast cancer: findings from the expansion phase. Breast Cancer Res Treat. 2021 Feb;185(3):759-771. doi: 10.1007/s10549-020-05995-7. Epub 2020 Nov 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ferumoxytol | Diagnostic / imaging agent | 5 mg/kg | Intravenous |
| Subject | Irinotecan Sucrosofate | Other / unclassified | 50 mg/m2 | Intravenous |
| Subject | Irinotecan Sucrosofate | Other / unclassified | 70 mg/m2 | Intravenous |