drugset / Trial / NCT03612466
A Dose Finding Study of CycloSam® Combined With External Beam Radiotherapy
NaSingle-groupOpen-labelTreatment
Summary
This is a dose finding study of a novel radiopharmaceutical agent, 153Sm-DOTMP. It will be studied alone and then in combination with external beam radiotherapy. The study design includes six cohorts, Levels 1-6. The first three cohorts of participants will receive 153Sm-DOTMP alone, and if this is determined to be safe, subsequent cohorts will receive the radiopharmaceutical followed by external beam radiotherapy.
Timeline
- Start
- 2022-08
- Primary completion
- 2023-01
- Completion
- 2024-09
Outcome
Outcome not reported
Stopped (Enrollment): “Study withdrawn before any participants could be enrolled. Issues being able to effectively recruit participants into the study.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SAMARIUM DOTMP | Other / unclassified | 18.5 mbq/kg | — |
| Subject | SAMARIUM DOTMP | Other / unclassified | 37 mbq/kg | — |
| Subject | SAMARIUM DOTMP | Other / unclassified | 111 mbq/kg | — |
| Subject | SAMARIUM DOTMP | Other / unclassified | 222 mbq/kg | — |
| Subject | SAMARIUM DOTMP | Other / unclassified | 370 mbq/kg | — |
| Background | AMD3100 | Small molecule | — | — |
| Background | Calcium carbonate | Other / unclassified | — | — |
| Background | filgrastim | Protein / enzyme biologic | — | — |