drugset / Trial / NCT00413283

Dose/ Schedule Finding Trial of Romiplostim for Chemotherapy-Induced Thrombocytopenia (CIT) in Non-Small Cell Lung Cancer (NSCLC)

NCT00413283

Phase 2 Completed 63 enrolled Amgen
RandomizedParallel-groupDouble-blindSupportive care

Summary

The purpose of this study is to identify an effective, well tolerated dose and schedule of romiplostim that is appropriate for the treatment of chemotherapy induced thrombocytopenia (CIT) in patients with non-small cell lung cancer receiving gemcitabine and platinum.

Timeline

Start
2006-12
Primary completion
2008-12
Completion
2009-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Romiplostim Peptide 250 ug Subcutaneous
Subject Romiplostim Peptide 500 ug Subcutaneous
Subject Romiplostim Peptide 750 ug Subcutaneous
Background Carboplatin Small molecule Intravenous
Background Cisplatin Other / unclassified Intravenous
Background Gemcitabine Small molecule Intravenous