ARTICLE | Clinical News

Indoximod: Phase Ib/II started

March 17, 2014 7:00 AM UTC

NewLink began an open-label, U.S. Phase Ib/II trial to evaluate oral indoximod in combination with temozolomide in about 18 temozolomide-refractory patients with advanced brain tumors. Patients in the Phase Ib portion will receive escalating doses of up to 1,200 mg indoximod twice daily, with a starting dose of 600 mg; and 150 mg/ m2 temozolomide for 5 days of each 28-day cycle.

Indoximod is in Phase II testing in combination with docetaxel to treat metastatic breast cancer and with Provenge sipuleucel-T to treat metastatic castration-resistant prostate cancer (CRPC). This year, the company also plans to begin Phase Ib/II testing of indoximod plus Yervoy ipilimumab to treat advanced melanoma and indoximod plus gemcitabine and Abraxane nab-paclitaxel to treat metastatic pancreatic cancer. ...