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 |