Study of Romiplostim for Chemo-induced Thrombocytopenia in Adults Subjects With Gastrointestinal or Colorectal Cancer

Official Title

RECITE: A Phase 3 Randomized Placebocontrolled Double-blind Study of Romiplostim for the Treatment of Chemotherapy-induced Thrombocytopenia in Patients Receiving FOLFOX-based Chemotherapy for Treatment of Gastrointestinal or Colorectal Cancer

Summary:

Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects with Gastrointestinal or Colorectal Cancer

Trial Description

Primary Outcome:

  • Incidence of a Thrombocytopenia-induced chemotherapy dose modification during the second or third on study chemotherapy cycles.
Secondary Outcome:
  • Depth of Platelet Count
  • First platelet response
  • Bleeding Events
  • Overall Survival
  • Subject incidence of Platelet Transfusion
  • Platelet Count
  • AEs/SAEs overall safety of romiplostim
A Phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy-induced Thrombocytopenia in Patients Receiving FOLFOX-based Chemotherapy for Treatment of Gastrointestinal or Colorectal Cancer

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society