Phase 2a Study of BAX69 and 5-FU/Leucovorin or Panitumumab Versus Standard of Care in Subjects With Metastatic Colorectal Cancer

Clinical Trial Details

BAX69391401

Phase 2a Study of BAX69 and 5-FU/Leucovorin or Panitumumab Versus Standard of Care in Subjects With Metastatic Colorectal Cancer

Purpose/Objective

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Full Trial Details: ClinicalTrials.gov

Condition: Colon Cancer
Study Type: Interventional
Phase: Phase II
Study Start Date: 05/15/2015
Study Completion Date: TBD

The purpose of this study is to evaluate the safety and tolerability of BAX69 in combination with 5-fluorouracil (5-FU)/leucovorin (LV) or panitumumab to determine the recommended phase II dose (RP2D) of each combination; and to compare the efficacy between BAX69 in combination with 5-FU/LV for subjects with KRAS or NRAS mutated tumor (mt) or panitumumab, for subjects with KRAS and NRAS wild type tumor (wt) and standard of care (SoC) per investigator choice as third or fourth treatment line in subjects with progressive measurable metastatic colorectal cancer (mCRC).

NCT Number
NCT02448810
Principal Investigator(s)
Paul Thambi, MD
Sponsor(s)
Baxalta US, Inc
Participant Eligibility
  • Age: 18 - No Maximum
  • Gender: Male, Female

Location

  • Shady Grove Adventist Aquilino Cancer Center
    9905 Medical Center Drive
    Rockville, MD 20850
    Main: 240-826-6297

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