drugset / Trial / NCT03152370
Preoperative Radiotherapy and E7046 in Rectum Cancer
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a multicenter, open-label, Phase 1b study in participants with locally advanced rectum cancer where primary resection without chemoradiotherapy is unlikely to achieve clear margins as defined by magnetic resonance imaging (MRI). It is conducted to assess the safety, to assess the tolerability, and to determine the recommended Phase 2 dose (RP2D) of E7046 in combination with pre-operative chemoradiotherapy. The study will also assess the efficacy of the combination in the expansion part at RP2D.
Timeline
- Start
- 2017-05-17
- Primary completion
- 2021-08-31
- Completion
- 2021-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 825 mg/m2 | — |
| Subject | Leucovorin | Small molecule | — | — |
| Subject | Oxaliplatin | Small molecule | — | — |
| Subject | PALUPIPRANT | Small molecule | — | Oral |
| Subject | fluorouracil | Small molecule | — | — |
Indications
No indication recorded.