Full TitleA Double-Blind, Placebo Controlled, Randomized, Dose-Escalating, Multi-Center, Phase 1 Study to Assess the Safety and Tolerability of ART-123 in Combination with Leucovorin/5-Fluorouracil/Oxaliplatin and Bevacizumab in Metastatic Colorectal Cancer Patients
In this study, researchers are finding the highest dose of ART-123 that can be given with colorectal cancer chemotherapy. The people in this study have colorectal cancer that has spread (metastasized). The chemotherapy drugs used are FOLFOX (leucovorin, 5-fluorouracil, and oxaliplatin) and bevacizumab.
Some people who get oxaliplatin have nerve problems like numbness, tingling, and pain in the hands and/or feet. This is called peripheral neuropathy. ART-123 could help treat or prevent peripheral neuropathy by blocking a particular protein and boosting an enzyme. This protein and enzyme are involved in neuropathy symptoms.
People in this study will be randomly assigned to get FOLFOX and bevacizumab with ART-123 or a placebo. If you join this study, you have a 75% chance of getting ART-123. The medicines in this study are given intravenously (by vein).
Who Can Join
To join this study, there are a few conditions. You must:
- Have metastatic colorectal cancer.
- Have completed any prior chemotherapy 6 or more months before getting the study treatment.
- Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
- Be age 18 or older.
For more information and to see if you can join this study, please contact Dr. Xi Chen’s office at 212-639-7507.