Phase III Trial Evaluates New Irinotecan Formulation in Colorectal Cancer
Goal is progression-free survival (Feb. 28)
A pivotal phase III clinical trial is evaluating HA-Irinotecan (Alchemia Limited) for the treatment of metastatic colorectal cancer in a total of 415 patients in Europe and Australia.
HA-Irinotecan is a new formulation of irinotecan that targets the drug to the tumor, thereby enabling irinotecan to be retained at the tumor site for a longer period and allowing more of the drug to be internalized by the cancer cells. In a phase II trial of HA-Irinotecan in metastatic colorectal cancer, the new formulation achieved a statistically significant increase in progression-free survival (PFS) compared with irinotecan (5.2 months vs. 2.4 months, respectively; P = 0.017), with no increase in toxicity.
The FDA has indicated that successful completion of the new phase III trial may be sufficient for the registration of HA-Irinotecan in the U.S.
The double-blind study is being conducted in second- and third-line colorectal cancer patients. The study’s primary objective is to demonstrate an increase in PFS without increasing treatment toxicity.
Source: Alchemia Limited; February 28, 2013.