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GU12-160

The Borealis-2 Clinical Trial: A Randomized Phase 2 Study Comparing Docetaxel Alone to Docetaxel in Combination With OGX-427 in Patients With Relapsed or Refractory Metastatic Urothelial Carcinoma After Receiving a Platinum-containing Regimen: Hoosier Cancer Research Network GU12-160

Status: Closed to Accrual

This is a randomized, open-label Phase 2 clinical trial to evaluate whether suppression of Hsp27 (Heat shock protein 27) production using OGX-427, a second-generation antisense oligonucleotide (ASO), in combination with docetaxel can prolong survival time compared to docetaxel alone in participants with locally advanced or metastatic urothelial carcinoma (UC) that are relapsed or refractory after receiving a platinum-containing regimen.

  • Condition:
    • Bladder Cancer
    • Urothelial Carcinoma
  • Intervention:
    • Drug: OGX-427
    • Drug: Docetaxel
  • Phase: Phase 2

For full description, see www.clinicaltrials.gov.

News Releases:

Abstracts/Posters/Presentations:

  • T.K. Choueiri, N.M. Hahn, S.K. Pal, A.S. Alva, R. Dreicer, A. Starodub, G. Sonpavde, J. H. Hoffman-Censits, J. Picus, A.V. Balar, E.A. Guancial, M.M. Regan, C. Jacobs, P.S. Stewart, J.E.. Rosenberg. The Borealis-2 clinical trial: A randomized phase 2 study of OGX-427 (apatorsen) plus docetaxel versus docetaxel alone in relapsed/refractory metastatic urothelial cancer. Hoosier Oncology Group GU12-160. Accepted as a TiP poster at the genitourinary (non-prostate) cancer general poster session at the ASCO Annual Meeting, May 30 – June 3, 2014, Chicago, Ill. J Clin Oncol 32:5s, 2014 (suppl; abstr TPS4593^). See abstract.
  • Choueiri TK, Hahn NM, Alva AS, Lauer RC, Dreicer R, Picus J, Pili R, Balar AV, Sonpavde G, Hoffman-Censits JH, Guancial EA, Alter R, Regan MM, Jacobs C, Stewart PS, Pal SK, Rosenberg JE. The Borealis-2 clinical trial: A randomized phase 2 study of OGX-427 (Apatorsen) plus docetaxel versus docetaxel alone in relapsed/refractory metastatic urothelial cancer: Hoosier Cancer Research Network GU12-160. Accepted as a TiP poster at the genitourinary (non-prostate) cancer general poster session at the ASCO Annual Meeting, May 29 – June 2, 2015, Chicago, Ill. J Clin Oncol 33:5s, 2015 (suppl; abstr TPS4577). See abstract.
  • Toni K. Choueiri, Noah M. Hahn, Lillian Werner, Meredith M. Regan, Jonathan E. Rosenberg, BOREALIS-02 investigators; Dana-Farber/Harvard Cancer Center, Boston, MA; Johns Hopkins University, Baltimore, MD; Dana-Farber Cancer Institute, Boston, MA; Memorial Sloan Kettering Cancer Center, New York, NY. Borealis-2: A randomized phase II study of OGX-427 (apatorsen) plus docetaxel versus docetaxel alone in platinum-resistant metastatic urothelial cancer (mUC) (Hoosier Cancer Research Network GU12-160). Accepted to Poster Session B at the ASCO 2017 Genitourinary Cancers Symposium, February 16-18, 2017, Orlando, Fla. J Clin Oncol 35, 2017 (suppl 6S; abstract 289). See abstract.

Project Manager: Ahran Lee, alee@hoosiercancer.org; (317) 634-5842, ext. 14.