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GU09-145

Phase I/II Study of BNC105P in Combination With Everolimus or Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma Following Prior Tyrosine Kinase Inhibitors

Status: Closed to Accrual

The purpose of this study is to determine whether BNC105P in combination with/following everolimus is effective in the treatment of progressive metastatic clear cell renal cell carcinoma following prior tyrosine kinase inhibitors.

  • Condition: Renal Cell Carcinoma
  • Intervention:
    • Drug: Everolimus
    • Drug: BNC105P
  • Phase: Phase 2

For full description, see www.clinicaltrials.gov.

Abstracts/Posters/Presentations:

  • T.E. Hutson, J. Sarantopoulos, T. Logan, G. Sonpavde, M.D. Galsky, C. Sweeney D.C. Bibby, G. Kremmidiotis , E.E. Doolin, N.M. Hahn. Phase I/II study of BNC105P in combination with everolimus or following everolimus for progressive metastatic renal cell carcinoma following prior tyrosine kinase inhibitors.:Hoosier Oncology Group GU09-145. Accepted to the Trial in Progress Poster Session at the ASCO Annual Meeting, June 4-8 2011, Chicago, IL. J Clin Oncol 29: 2011 (suppl; abstr TPS194)
  • TE Hutson, LH Dang, RC Lauer, A Starodub, RJ Hauke, MD Galsky, KA Bylow, T Logan, CL Cowey, DC Bibby, G Kremmidiotis, EE Doolin, TC Lavranos, G Sonpavde, NM Hahn, C Sweeney, J Sarantopoulos. Phase I results of a phase I/II trial of BNC105P with everolimus in metastatic renal cell carcinoma (mRCC) patients previously treated with VEGFR tyrosine kinase inhibitors: Hoosier Oncology Group GU09-145. Accepted to the General Poster Session at the ASCO Annual Meeting, June 1-5, 2012, Chicago IL. J Clin Oncol 30, 2012 (suppl; abstr 4603)
  • TE Hutson, LH Dang, RC Lauer, A Starodub, RJ Hauke, T Logan, KA Bylow, MD Galsky, DC Bibby, G Kremmidiotis, EE Doolin, TC Lavranos, AF Leske, NM Hahn, G Sonpavde, C Sweeney, J Sarantopoulos. Phase I/II study of a BNC105P/everolimus regimen for progressive metastatic renal cell carcinoma (mRCC) following prior tyrosine kinase inhibitors: Hoosier Oncology Group GU09-145. Accepted to the General Poster Session E at the ASCO 2012 Genitourinary Cancers Symposium, February 2-4, 2012, San Francisco, CA. J Clin Oncol 30, 2012 (suppl 5; abstr 373)

Manuscripts/Articles:

  • Pal SK, Azad AA, Bhatia S, Drabkin HA, Costello B, Sarantopoulos J, Kanesvaran R, Lauer R, Starodub AN, Hauke RJ, Sweeney CJ, Hahn NM, Sonpavde G, Richey S, Breen T, Kremmidiotis G, Leske AF, Doolin E, Bibby DC, Simpson J, Iglesias J, Hutson TE. A phase I/II trial of BNC105P with everolimus in metastatic renal cell carcinoma (mRCC) GU09-145. Clin Cancer Res. 2015 Mar 18. pii: clincanres.3370.2014. [Epub ahead of print] PMID: 25788492

Project Manager: Donna LaPlaca Sullivan, dsullivan@hoosiercancer.org; (317) 634-5842, ext. 40.