drugset / Trial / NCT02413853

Combination Chemotherapy and Bevacizumab With or Without PRI-724 in Treating Patients With Newly Diagnosed Metastatic Colorectal Cancer

NCT02413853 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized phase II trial studies how well combination chemotherapy and bevacizumab with or without CBP/beta-catenin antagonist PRI-724 (PRI-724) works in treating patients with newly diagnosed colorectal cancer that has spread to other places in the body. Drugs used in chemotherapy, such as leucovorin calcium, oxaliplatin, and fluorouracil, 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. Monoclonal antibodies, such as bevacizumab, may block tumor growth in different ways by targeting certain cells. PRI-724 may help stop the growth of cancer cells by blocking the specific signaling pathway that cancer cells need to grow and spread. It is not yet known whether combination chemotherapy and bevacizumab works better with or without PRI-724 in treating patients with metastatic colorectal cancer.

Timeline

Start
2015-11
Primary completion
2017-11
Completion
2018-11

Outcome

Outcome not reported

Stopped: “Study drug supply issues”

Drugs

EvaluationDrugModalityDoseRoute
Subject PRI-724 Small molecule — Intravenous
Background Bevacizumab Monoclonal antibody — Intravenous
Background Leucovorin Small molecule — Intravenous
Background Oxaliplatin Small molecule — Intravenous
Background fluorouracil Small molecule — Intravenous