XL184: Interim Phase II data

Interim data from 273 evaluable patients in the lead-in stage of an ongoing, adaptive Phase II trial showed that once-daily oral XL184 produced 39 partial responses and 100 cases of stable disease at week 12. The 12-week disease control rate (DCR) was 49%. In the lead-in stage of the study, patients receive once-daily 100 mg XL184 for 12 weeks. Patients who achieve a partial response (PR) continue open-label treatment, patients with progressive disease discontinue treatment and patients with stable disease (SD) enter the randomized discontinuation placebo-controlled study. As of Nov. 1, the trial had enrolled 397 patients with 1 of 9 types of solid tumor, with a planned total enrollment of about 600 patients.

Additionally, interim data from 31 evaluable patients in the cohort of subjects with advanced epithelial ovarian cancer, primary peritoneal or fallopian tube carcinoma in the lead-in stage of the adaptive Phase II trial showed that XL184 produced 10 confirmed PRs, plus 15 cases of SD. The 12-week DCR was 64%. XL184 also led to tumor shrinkage in 30 of 37 evaluable patients with measurable metastatic lesions. In 17 evaluable platinum-refractory/resistant patients, XL184 produced 5 confirmed PRs, plus 7 cases of SD. ...