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

NCT00413283 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2013-10-24

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Romiplostim

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

DRUG

Placebo

Placebo subcutaneous injection.

DRUG

Gemcitabine

Intravenous infusion

DRUG

Carboplatin

Intravenous infusion

DRUG

Cisplatin

Intravenous infusion

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2008-12-31
Completion
2009-02-28

Countries

  • United States
  • Austria
  • Canada
  • Germany
  • Hungary
  • Ireland
  • Italy
  • Portugal

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00413283 on ClinicalTrials.gov