CTI further refines Xyotax population in new Phase III
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
A confirmatory Phase III trial of Cell Therapeutics' polymer-linked paclitaxel Xyotax is recruiting women with advanced non-small cell lung cancer who have premenopausal estrogen levels (>30 pg/mL). The PGT307 trial, designed under a special protocol assessment with FDA, will enroll 450 women with NSCLC performance status 0, 1, or 2, who will be randomized to Xyotax (paclitaxel poliglumex) plus carboplatin or paclitaxel/carboplatin. CTI has been highlighting its plans for a normal estrogen level protocol to support a "gender medicine" NDA (1Pharmaceutical Approvals Monthly, December 2006, p. 11). An earlier gender-specific trial, the PIONEER study, enrolled women with both normal and abnormal estrogen levels, but was terminated late last year due to early cycle deaths in both arms. CTI has been trying to isolate the effect observed in women in its STELLAR pivotal program. The traditional gender-neutral program failed to meet endpoints in the total NSCLC population, but showed a benefit in women...