drugset / Trial / NCT02396368
A Study of Radium-223 in Combination With Tasquinimod in Bone-only Metastatic Castration-Resistant Prostate Cancer
NaSingle-groupOpen-labelTreatment
Summary
This is a Phase I/Ib study of Radium-223 in combination with Tasquinimod for patients with bone metastases from castration-resistant prostate cancer (CRPC). The investigators propose to determine the spectrum of tolerability of the combination of tasquinimod and radium-223 and determine a dose for a subsequent randomized phase II study (first cohort) and the proportion of men with bone-specific alkaline phosphatase response (second cohort).
Timeline
- Start
- 2015-03
- Primary completion
- 2017-07
- Completion
- 2017-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Radium-223 dichloride | Other / unclassified | 0.05 mbq/kg | Intravenous |
| Subject | Tasquinimod | Small molecule | 0.25 mg | Oral |
| Subject | Tasquinimod | Small molecule | 0.5 mg | Oral |
| Subject | Tasquinimod | Small molecule | 1 mg | Oral |