drugset / Trial / NCT03545711
Safety and Efficacy of Anlotinib in Combination With Irinotecan in Patients With Pretreated Advanced Colorectal Cancer
NaSingle-groupOpen-labelTreatment
Summary
Patients with pretreated advanced colorectal cancer are recruited to the phase I portion of this prospective non-randomised study in an escalated dose cohort. The primary endpoint of the dose-escalation phase is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of anlotinib when given in combination with irinotecan. The phase II (dose-expansion) portion is designed to characterize the safety and potential efficacy of the combination therapy in pretreated advanced colorectal cancer patients.
Timeline
- Start
- 2018-05-26
- Primary completion
- 2019-11-24
- Completion
- 2020-11-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Catequentinib | Small molecule | 8 mg | — |
| Background | Irinotecan | Small molecule | 180 mg/m2 | — |