drugset / Trial / NCT03909724

Pulsatile High-dose Sunitinib Versus TAS-102 in Patients With Metastatic Colorectal Carcinoma (mCRC)

NCT03909724

Phase 2/3 Unknown 60 enrolled Amsterdam UMC, location VUmc
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare progression free survival rates of metastasized colorectal cancer patients refractory or intolerant to systemic therapy with fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF therapy and anti-EGFR therapy (for tumours with wild-type KRAS)); randomized for treatment with TAS-102 (standard-arm) or High Dose Intermittent Sunitinib (700 mg once every 2 weeks). The investigators hypothesis is that treatment with the experimental arm (sunitinib) will provide an improvement in progression free in this patient group.

Timeline

Start
2019-10-01
Primary completion
2021-07-01
Completion
2022-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Sunitinib Small molecule 700 mg Oral
Comparator TAS-102 Small molecule 35 mg/m2