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

Table 2 Summary of the phase II clinical trials of custirsen

Clinical trial	Notes	Drugs	Patients, n
OGX-011-3[26] Docetaxel and prednisone with or without OGX-011 in treating patients with recurrent or metastatic prostate cancer that did not respond to previous hormone therapy (NCT00258388)	Randomized, two-arm, open label, multi-center study in patients who received docetaxel/prednisone with/without custirsen	Custirsen sodium: 640 mg iv for 2 h-Cycle 1: days 7, 5, 3, 1, 8, 15 (4 wk cycle) Docetaxel: 75 mg/m2 iv for 1 h-day 1 every 3 wk (3 wk cycles) Prednisone: 5 mg PO bid	82
0GX-011-04 Hormone ablation therapy in patients with localized prostate cancer	A single-arm, open-label, single center study to assess the effects of combined hormone ablation therapy and weekly treatment with custirsen prior to surgical removal of the prostate gland	LHRH agonist (hormone ablation) was given with weekly custirsen treatment for 12 wk and prostatectomy performed within 14 d of the last dose of custirsen	24
OGX-011-05[28] A study of OGX-011/Gemcitabine/Platinum-based regimen in stage IIIB/IV non-small cell lung cancer (NCT00138658)	An open-label trial to assess the safety and anti-tumor effect of OGX-011 when given to patients in combination with GEM and CIS/CARB	Custirsen sodium: 640 mg iv for 2 h Cycle 1: days 7, 5, 3 and days 1, 8, 15 of every 21-d cycle GEM: days 1 and 8 Cisplatin/Carboplatin: day 1 6 cycle 2	81
OGX-011-06[29] OGX-011 and docetaxel in treating women with locally advanced or metastatic breast cancer (NCT00258375)	To study how well giving OGX-011 together with docetaxel works in treating women with locally advanced or metastatic breast cancer	Custirsen sodium: 640 mg iv for 2 h on days 7, 5, 3, 1, 8 and 15 of cycle 1 and on days 1, 8, 15 on the other cycle Docetaxel: 75 mg/m2 iv for 1 h on days 1 and 8	15
OGX-011-07[27] Evaluation of safety and feasibility of OGX-011 in combination with second line chemotherapy in patients with HRPC (NCT00327340)	A multicenter, open-label, randomized study evaluating the safety and feasibility of custirsen in combination with second line chemotherapy in patients with HRPC	Prednisone: 5 mg twice daily through completion of the final treatment cycle. Custirsen: 640 mg iv for 2 h on days 9 to 1 of every cycle Mitoxantrone: 12 mg/m2, iv on day 1. Docetaxel: 75 mg/m2, iv on day 1	42
Assessing the effects of combined therapy with androgen ablation and OGX-011 given prior to radical prostatectomy on pathologic complete response rates in men with localized prostate cancer and high risk features (NCT00138918)	An open-label, non-blinded, phase II clinical, tissue pharmacokinetic and pharmacodynamics study of weekly OGX-011 and neoadjuvant hormone therapy prior to radical prostatectomy in patients with localized prostate carcinoma and high risk features	Neoadjuvant hormone therapy: buserelin 9.9 mg subcutaneously × 1 injection with flutamide 250 mg orally tid for the first 4 wk OGX-011: 640 mg by intravenous infusion over 2 h on days 1, 3, and 5	45