Trials / Completed
CompletedNCT00413283
Dose/ Schedule Finding Trial of Romiplostim for Chemotherapy-Induced Thrombocytopenia (CIT) in Non-Small Cell Lung Cancer (NSCLC)
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.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 63 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
- Lung Cancer
- Chemotherapy-Induced Thrombocytopenia
- Non-Small Cell Lung Cancer
- Cancer
- Lung Neoplasms
- Oncology
- Solid Tumors
- Thrombocytopenia
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2006-12-01
- Primary completion
- 2008-12-01
- Completion
- 2009-02-01
- First posted
- 2006-12-19
- Last updated
- 2013-10-24
- Results posted
- 2010-10-21
Locations
113 sites across 8 countries: United States, Austria, Canada, Germany, Hungary, Ireland, Italy, Portugal
Source: ClinicalTrials.gov record NCT00413283. Inclusion in this directory is not an endorsement.