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

Phase 3 Completed 165 enrolled Amgen

RandomizedParallel-groupDouble-blindTreatment

Summary

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

Timeline

Start: 2019-09-30
Primary completion: 2024-01-25
Completion: 2025-01-09

Outcome

Met primary endpoint

registry NUMBER Romiplostim: 84.4 (76.21 to 90.64) percentage of participants NUMBER Placebo: 35.7 (23.36 to 49.64) percentage of participants analysis (superiority test); Romiplostim vs Placebo; p < 0.001 NCT03362177 ↗

paper which corresponded to an odds ratio of 10.16 (95% confidence interval [CI], 4.44 to 23.72; P<0.001) PMID 41812193 ↗

Publications

Al-Samkari H, Munoz C, Geredeli C, Korantzis I, Gonzalez Astorga B, Arslan C, Cordeiro Camargo JF, Scotte F, Borges G, Wang K, Eisen M, Kuter DJ, Soff GA. Romiplostim versus Placebo for Chemotherapy-Induced Thrombocytopenia. N Engl J Med. 2026 Mar 12;394(11):1061-1073. doi: 10.1056/NEJMoa2511882.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Romiplostim	Peptide	—	Subcutaneous