drugset / Trial / NCT00283439

A Dose and Schedule Finding Trial With AMG 531 for Chemotherapy Induced Thrombocytopenia (CIT) in Adults With Lymphoma

NCT00283439 ↗

Phase 1/2 Completed 39 enrolled Amgen
Parallel-groupOpen-labelSupportive care

Summary

The purpose of this study is to identify a well-tolerated, effective dose and schedule of AMG 531 for the treatment of Chemotherapy Induced Thrombocytopenia (CIT) in subjects with lymphoma receiving multi-cycle chemotherapy.

Timeline

Start
2005-10
Primary completion
2008-05
Completion
2008-09

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Romiplostim 100 µg vs Romiplostim 1000 µg; p = 0.9654; Satterhwaite t-test; note: One-sided test NCT00283439 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Romiplostim Peptide 100 ug —
Subject Romiplostim Peptide 300 ug —
Subject Romiplostim Peptide 700 ug —
Subject Romiplostim Peptide 1000 ug —