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A Multicenter Study With an Open-label Phase Ib Part Followed by a Randomized, Placebo-controlled, Double-blind, Phase II Part to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of the DNA-PK Inhibitor M3814 in Combination With Capecitabine and Radiotherapy in Participants With Locally Advanced Rectal Cancer

Conditions

Rectum

Phase 1B/2

What is the purpose of this trial?

The main purpose of the study is to define maximum tolerated dose (MTD), recommended Phase II dose (RP2D) of M3814 in combination with capecitabine and radiotherapy (RT) in Phase Ib and to evaluate the efficacy of M3814 in terms of Pathological Clinical Response (pCR)/Clinical Complete Response (cCR) when administered in combination with capecitabine and RT versus placebo, capecitabine, and RT in Phase II.

  • Trial with
    EMD Serono, Inc.
  • Start Date
    12/12/2019
  • End Date
    04/19/2020
Trial Image

For more information about this study, contact:

Christina Wiess

I'm interested in volunteering

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 877.978.8343

  • Last Updated
    01/20/2020
  • Study HIC
    #2000026061