drugset / Trial / NCT04164069

Dasatinib for the Prevention of Oxaliplatin-Induced Neuropathy in Patients With Metastatic Gastrointestinal Cancer Receiving FOLFOX Chemotherapy With or Without Bevacizumab

NCT04164069

Phase 1 Completed 9 enrolled Anne Noonan
NaSingle-groupOpen-labelPrevention

Summary

This phase Ib trial studies side effects and best dose of dasatinib in preventing oxaliplatin-induced peripheral neuropathy in patients with gastrointestinal cancers who are receiving FOLFOX regimen with or without bevacizumab. Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin (FOLFOX regimen), work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. However, the buildup of oxaliplatin in the cranial nerves can result in damage or the nerves. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Blocking these enzymes may reduce oxaliplatin-induced peripheral neuropathy.

Timeline

Start
2020-09-02
Primary completion
2023-06-22
Completion
2023-06-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Oxaliplatin Small molecule Intravenous
Subject dasatinib anhydrous Small molecule Oral
Background Bevacizumab Monoclonal antibody Intravenous
Background Leucovorin Small molecule Intravenous
Background fluorouracil Small molecule Intravenous