drugset / Trial / NCT01256762
Imetelstat in Combination With Paclitaxel (With or Without Bevacizumab) in Patients With Locally Recurrent or Metastatic Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of treatment with imetelstat + paclitaxel (with or without bevacizumab) versus paclitaxel (with or without bevacizumab) alone for patients with locally recurrent or metastatic breast cancer who have not received chemotherapy or have received one non-taxane based chemotherapy for metastatic breast cancer.
Timeline
- Start
- 2010-11
- Primary completion
- 2012-10
- Completion
- 2012-12
Publications
- Background Hochreiter AE, Xiao H, Goldblatt EM, Gryaznov SM, Miller KD, Badve S, Sledge GW, Herbert BS. Telomerase template antagonist GRN163L disrupts telomere maintenance, tumor growth, and metastasis of breast cancer. Clin Cancer Res. 2006 May 15;12(10):3184-92. doi: 10.1158/1078-0432.CCR-05-2760.
- Background Goldblatt EM, Gentry ER, Fox MJ, Gryaznov SM, Shen C, Herbert BS. The telomerase template antagonist GRN163L alters MDA-MB-231 breast cancer cell morphology, inhibits growth, and augments the effects of paclitaxel. Mol Cancer Ther. 2009 Jul;8(7):2027-35. doi: 10.1158/1535-7163.MCT-08-1188. Epub 2009 Jun 9.
- Background Herbert BS, Wright WE, Shay JW. Telomerase and breast cancer. Breast Cancer Res. 2001;3(3):146-9. doi: 10.1186/bcr288. Epub 2001 Feb 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Imetelstat | Oligonucleotide (other) | 300 mg/m2 | — |
| Background | Bevacizumab | Monoclonal antibody | 15 mg/kg | — |
| Background | Paclitaxel | Small molecule | 90 mg/m2 | — |