| General information |
| Database: | DB00802 |
| Objective: | Clusterin is an antiapoptotic protein activated in response to cellular stress. OGX011 is a secondgeneration antisense oligonucleotide that inhibits clusterin expression. The primary objective of thisphase II trial was to assess the safety and efficacy of the combination of OGX011 and docetaxel for metastatic breast cancer. |
| Authors: | Chia S, et al |
| Title: | Phase II trial of OGX011 in combination with docetaxel in metastatic breast cancer. |
| Journal: | Clin Cancer Res. |
| Year: | 2009 |
| PMID: | 19147778 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | OGX011
|
| Target: | mRNA of Clusterin
|
| Cancer Type: | breast cancer |
| Cancer Subtype: | advanced breast cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | OGX011 + docetaxel |
| Study Type: | phase II trial |
| Key Patients Feature: | Women with measurable metastatic breast cancer and |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Three loading doses of OGX011 640 mg i.v. followed by weekly OGX011 and docetaxel 75 mg/m(2) (every 3 weeks) were given. A twostage design was used with a hypothesis of H(0) or=55%. Objective response in >or=6 of the first 14 patients was required for the trial to continue to the second stage. |
| Primary End Point: | safety and efficacy of the combination of OGX011 and docetaxel |
| Secondary End Point: | NA |
| Patients Number: | 15 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 0.33 |
| Disease Control Rate: | 60% |
| Median Time to Progression: | 8 months (95% confidence interval, 5.629.43 months) |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | The median overall survival was not reached at the time of data analysis; however, the 75 percentile for overall survival was 11.1 months. |
| Adverse Event(agent arm): | The duration of response ranged from 2.7 to 7.3 months with a median of 4.9 months. An additional 9 (60%) patients showed stable disease with a median duration of stable disease of 9.3 months (range, 1.69.3 months). |
| Conclusions: | The combination of OGX011 and docetaxel at 75 mg/m(2) is well tolerated and clinical activity was seen in these patients with metastatic breast cancer, but there was an insufficient number of responses to meet the criteria for proceeding to the second stage of accrual. |