NCT03362177

Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Gastrointestinal, Pancreatic, or Colorectal Cancer

RECITE: A Phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy- Induced Thrombocytopenia in Patients Receiving Oxaliplatin-based Chemotherapy for Treatment of Gastrointestinal, Pancreatic, or Colorectal Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

RECITE: A phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy-induced Thrombocytopenia in Patients Receiving Oxaliplatin-based Chemotherapy for Treatment of Gastrointestinal, Pancreatic, or Colorectal Cancer

Conditions

• Chemotherapy-induced Thrombocytopenia

Interventions

Type	Name	Description
BIOLOGICAL	Romiplostim	This study is designed to study Romiplostim for the treatment of chemotherapy-induced thrombocytopenia (CIT) in patients receiving chemotherapy for the treatment of gastrointestinal/colorectal/pancreatic cancer.
OTHER	Placebo	Placebo Comparator

Timeline

• Start date: 2019-09-30
• Primary completion: 2024-01-25
• Completion: 2025-01-09
• First posted: 2017-12-05
• Last updated: 2026-02-11
• Results posted: 2026-02-11

Locations

117 sites across 20 countries: United States, Argentina, Austria, Brazil, Bulgaria, Canada, Colombia, France, Greece, Hungary, Italy, Mexico, Peru, Poland, Portugal, Romania, Russia, Spain, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study