Clusterin: Review of research progress and looking ahead to direction in hepatocellular carcinoma

Table 3 Summary of the phase III clinical trials of custirsen

Phase III trial	Treatment and Arms	Patients, n	Completion Date
ENSPIRIT A multinational, randomized, open-label study of custirsen in patients with advanced or metastatic non-small cell lung cancer (NCT01630733)	Arm A: Custirsen Docetaxel Custirsen: Three loading doses of custirsen 640 mg iv over 2 h administered in 5 to 9 d prior to day 1 of cycle 1, then custirsen 640 mg iv weekly every 21-d cycle Docetaxel: 75 mg/m2 iv over 1 h on day 1 of every 21-d cycle Arm B: Docetaxel Docetaxel: 75 mg/m2 iv over 1 h on day 1 of every 21-d cycle until disease progression, unacceptable toxicity, withdrawal of consent or protocol specified parameters to stop treatment	1100	July, 2017
AFFINITY	Drugs: cabazitaxel, prednisone, custirsen sodium	630	December, 2015
Comparison of cabazitaxel/prednisone alone or in combination with custirsen for second line chemotherapy in prostate cancer (NCT01578655)	Following 2 loading doses of custirsen (640 mg iv), cabazitaxel (25 mg/2 iv) is administered on a 3-wk cycle with weekly custirsen (640 mg iv) and daily prednisone (10 mg PO) until disease progression, unacceptable toxicity, or completion of 10 cycles Drugs: cabazitaxel, prednisone Cabazitaxel (25 mg/m2 iv) is administered on a 3-wk cycle with daily prednisone (10 mg PO) until disease progression, unacceptable toxicity, or completion of 10 cycles
SYNERGY Comparison of docetaxel/prednisone to docetaxel/prednisone in combination with OGX-011 in men with prostate cancer (NCT01188187)	Drugs: custirsen sodium, docetaxel, prednisone Docetaxel/prednisone on a 3-wk cycle with weekly OGX-011 640 mg infusions until disease progression, unacceptable toxicity, or completion of 10 cycles. Drugs: docetaxel, prednisone Docetaxel/prednisone on a 3-wk cycle until disease progression, unacceptable toxicity, or completion of 10 cycles	1023	April, 2014