drugset / Trial / NCT02880943
Dose-finding, Safety and Efficacy Study of Radium-223 Dichloride (XOFIGO) in RCC Patients With Bone Metastases. (EIFFEL)
Phase 1/2
Unknown
42 enrolled
Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a prospective, multicentre, open-label, phase I/II study to evaluate the maximum tolerated dose (MTD), and the most successful dose (MSD) of XOFIGO®, in renal cancer patients with metastases to bone, without (Group A) or with (Group B) visceral metastases.
Timeline
- Start
- 2016-10
- Primary completion
- 2020-10
- Completion
- 2021-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Radium-223 dichloride | Other / unclassified | 0.0275 mbq/kg | Intravenous |
| Subject | Radium-223 dichloride | Other / unclassified | 0.055 mbq/kg | Intravenous |
| Subject | Radium-223 dichloride | Other / unclassified | 0.088 mbq/kg | Intravenous |
| Subject | Radium-223 dichloride | Other / unclassified | 0.11 mbq/kg | Intravenous |