BioCentury
ARTICLE | Clinical News

GDC-0973: Interim Phase Ib data

October 15, 2012 7:00 AM UTC

Interim data from 70 patients with locally advanced or unresectable metastatic melanoma and a BRAF V600 mutation in the dose-escalation Phase Ib BRIM7 trial showed that 2 cohorts evaluating 60 mg oral GDC-0973 plus 720 or 960 mg oral Zelboraf vemurafenib met the protocol-defined criteria for safety and were expanded to include up to 20 BRAF inhibitor-naïve patients who progressed on Zelboraf. There was 1 DLT of grade 3 QT interval prolongation reported at the MTD of 960 mg Zelboraf plus 60 mg GDC-0973. The most common adverse events were non-acneiform rash, diarrhea, photosensitivity, fatigue and nausea. The trial enrolled 10 cohorts of 3-6 patients each to receive twice-daily 720 or 960 mg Zelboraf plus once-daily 60, 80 or 100 mg GDC-0973. Data were presented at the European Society for Medical Oncology meeting in Vienna. ...