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COMPLETED Phase 2

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

NCT00413283 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Carboplatin
  • DRUG Placebo
  • DRUG Cisplatin
  • DRUG Gemcitabine
  • BIOLOGICAL Romiplostim

Study Locations (20)

California

  • Research Site — Anaheim
  • Research Site — Anaheim
  • Research Site — Los Angeles
  • Research Site — Los Angeles
  • Research Site — Rancho Mirage
  • Research Site — Rancho Mirage

Florida

  • Research Site — Boynton Beach
  • Research Site — Boynton Beach
  • Research Site — Vero Beach
  • Research Site — Vero Beach

Georgia

  • Research Site — Athens
  • Research Site — Athens
  • Research Site — Macon
  • Research Site — Macon

Arizona

  • Research Site — Glendale
  • Research Site — Glendale

Illinois

  • Research Site — Peoria
  • Research Site — Peoria

Iowa

  • Research Site — Sioux City
  • Research Site — Sioux City

Trial Details

FieldValue
Enrollment Target 63 participants
Start Date 2006-12
Est. Completion 2009-02
Phase Phase 2

Sponsor

Amgen

266 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00413283

The ClinicalTrials.gov registry entry for NCT00413283 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 266 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 8 conditions, with Cancer appearing as the primary indexed condition, and to 5 interventions — of which Carboplatin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00413283 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00413283 about?

NCT00413283 is a clinical study titled "Dose/ Schedule Finding Trial of Romiplostim for Chemotherapy-Induced Thrombocytopenia (CIT) in Non-Small Cell Lung Cancer (NSCLC)". 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.

What is the current status of trial NCT00413283?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2006-12. Estimated completion is 2009-02.

What conditions does trial NCT00413283 study?

This clinical trial studies the following conditions: Cancer, Lung Cancer, Non-Small Cell Lung Cancer, Solid Tumors, Oncology. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00413283?

The interventions under investigation include: Carboplatin (DRUG), Placebo (DRUG), Cisplatin (DRUG), Gemcitabine (DRUG), Romiplostim (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00413283?

This trial is sponsored by Amgen, which has 266 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00413283 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial