drugset / Trial / NCT00291785

Phase I/II CT 2106 and 5-FU/FA in Colorectal Cancer

NCT00291785

Phase 1/2 Completed 48 enrolled CTI BioPharma
Non-randomizedSingle-groupOpen-labelTreatment

Summary

CT-2106, a camptothecin (CPT) conjugate, is a new generation of topoisomerase I inhibitors designed to deliver higher, more effective chemotherapy to tumor tissue with less toxicity to normal tissues. The objective of this study is to determine the dose limiting toxicities, safety profile and antitumor activity of CT-2016 in combination with 5-FU and folic acid for the treatment of colorectal cancer.

Timeline

Start
2004-01
Primary completion
2007-08
Completion
2008-09

Drugs

EvaluationDrugModalityDoseRoute
Subject CT-2106 Other / unclassified
Background Leucovorin Small molecule 200 mg Intravenous
Background fluorouracil Small molecule 400 mg/m2 Intravenous
Background fluorouracil Small molecule 600 mg/m2 Intravenous

Indications