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NCT03301857 · ClinicalTrials.gov registry record · Phase 4

Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004

A Phase 4 study of Giant Cell Tumor of Bone, sponsored by Amgen.

Completed
Registry status
Phase 4
Development phase
85
Enrollment target
14
Study locations

NCT03301857 is a Phase 4 study of Giant Cell Tumor of Bone that has completed, run by Amgen. The registered enrollment target is 85 participants, below the 317-participant average among 3 other Giant Cell Tumor of Bone trials with a reported enrollment target (73% lower). The trial reports 14 study locations across 8 states.

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The verdict

NCT03301857, a Phase 4 study of Giant Cell Tumor of Bone, has completed, sponsored by Amgen.

COMPLETED
Registry status
Phase 4
Development phase
85 participants
Enrollment target
14
Study locations

Study Summary

Study 20140114 will continue to follow participants with GCTB who were treated in Study 20062004 and remained on the study at the completion of Study 20062004 for an additional 5 years on long-term safety follow up.

Conditions Studied

Interventions

  • DRUG Denosumab

Study Locations (14)

Other

  • Centre Leon Berard - Lyon
  • Institut Gustave Roussy - Villejuif
  • Istituti Ortopedici Rizzoli - Bologna
  • Instytut Matki i Dziecka - Warsaw
  • Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie â€" Panstwowy Instytut Badawczy - Warsaw
  • Skane Universitetssjukhus - Lund
  • Royal Orthopaedic Hospital - Birmingham

California

  • Sarcoma Oncology Research Center LLC - Santa Monica

District of Columbia

  • Washington Cancer Institute at MedStar Washington Hospital - Washington D.C.

Minnesota

  • University of Minnesota Medical Center Fairview - Minneapolis

New York

  • Mount Sinai Beth Israel Downtown - New York

Pennsylvania

  • Abramson Cancer Center at Pennsylvania Hospital - Philadelphia

New South Wales

  • Royal Prince Alfred Hospital - Camperdown

Balearic Islands

  • Hospital Universitari Son Espases - Palma de Mallorca

Trial Details

FieldValue
Enrollment Target 85 participants
Start Date 2017-11-13
Est. Completion 2023-07-27
Phase Phase 4

Sponsor

Amgen

558 total trials

What the Registry Record Tells You About NCT03301857

The ClinicalTrials.gov registry entry for NCT03301857 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 85 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 317-participant average among 3 other Giant Cell Tumor of Bone trials with a reported enrollment target (73% lower). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Giant Cell Tumor of Bone appearing as the primary indexed condition, and to 1 intervention - of which Denosumab is the first listed.

NCT03301857 reports 14 study locations spanning 8 distinct geographic areas - top geographies include Other, California, District of Columbia.

Frequently Asked Questions

What is clinical trial NCT03301857 about?

NCT03301857 is a clinical study titled "Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004". Study 20140114 will continue to follow participants with GCTB who were treated in Study 20062004 and remained on the study at the completion of Study 20062004 for an additional 5 years on long-term safety follow up.

What is the current status of trial NCT03301857?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 85 participants. The study started on 2017-11-13. Estimated completion is 2023-07-27.

What conditions does trial NCT03301857 study?

This clinical trial studies the following conditions: Giant Cell Tumor of Bone.

What interventions are being tested in trial NCT03301857?

The interventions under investigation include: Denosumab (DRUG).

Who is sponsoring clinical trial NCT03301857?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03301857 being conducted?

This trial has 14 study locations across California, District of Columbia, Minnesota, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.