CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 63 enrolled
Drug / intervention
Romiplostim +4 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00413283
NCT00413283Phase 2Completed

Phase 2, Randomized, Double Blind, Placebo-Controlled Dose and Schedule Finding Trial to Evaluate the Safety and Efficacy of AMG 531 For Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Advanced Non-Small Cell Lung Cancer Already Receiving Gemcitabine and Platinum.

Amgen·interventional·Posted Dec 19, 2006·Updated Oct 24, 2013

In Brief

A Phase 2 clinical trial evaluating Romiplostim, Placebo, and 3 other interventions for Lung Cancer and 7 related conditions. Completed, enrolled 63 participants across 113 sites in 8 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Canada, Germany, Hungary, Ireland, Italy, Portugal, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 19, 2006
Enrollment StartDec 1, 2006
Primary CompletionDec 1, 2008
Study CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 19.5 years ago

Interventions

Romiplostimbiological

Romiplostim is a thrombopoiesis recombinant protein that targets the thrombopoietin (TPO) receptor which results in increased platelet production.

Placebodrug

Placebo subcutaneous injection.

Gemcitabinedrug

Intravenous infusion

Carboplatindrug

Intravenous infusion

Cisplatindrug

Intravenous infusion