drugset / Trial / NCT04942626
Capecitabine-based Chemoradiotherapy in Combination With the IL-1 Receptor Antagonist Anakinra for Rectal Cancer Patients
NaSingle-groupOpen-labelTreatment
Summary
The ACO/ARO/AIO-21 investigator-driven, open-labeled, phase I drug re-purposing trial will assess whether the IL-1 receptor antagonist Anakinra can be safely combined with fluoropyrimidine-based chemoradiotherapy (CRT) in patients with rectal cancer.
Timeline
- Start
- 2021-08-20
- Primary completion
- 2024-12-31
- Completion
- 2024-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Anakinra | Protein / enzyme biologic | 100 mg | Subcutaneous |
| Subject | Capecitabine | Small molecule | 500 mg/m2 | Oral |
| Subject | Capecitabine | Small molecule | 650 mg/m2 | Oral |
| Subject | Capecitabine | Small molecule | 825 mg/m2 | Oral |