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NCT01004224 · ClinicalTrials.gov registry record · Phase 1

A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies

A Phase 1 study of Advanced Solid Tumors With Alterations of FGFR1, 2 and or 3 and Squamous Lung Cancer With FGFR1 Amplification, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
208
Enrollment target
20
Study locations

NCT01004224 is a Phase 1 study of Advanced Solid Tumors With Alterations of FGFR1, 2 and or 3 and Squamous Lung Cancer With FGFR1 Amplification that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 208 participants. The trial reports 20 study locations across 12 states.

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The verdict

NCT01004224, a Phase 1 study of Advanced Solid Tumors With Alterations of FGFR1, 2 and or 3 and Squamous Lung Cancer With FGFR1 Amplification, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
208 participants
Enrollment target
20
Study locations

Study Summary

The study will determine the maximum tolerated dose and thus the recommended phase II dose and schedule of the compound and characterize the safety.

Conditions Studied

Advanced Solid Tumors With Alterations of FGFR1, 2 and or 3 Squamous Lung Cancer With FGFR1 Amplification Bladder Cancer With FGFR3 Mutation or Fusion Advanced Solid Tumors With FGFR1 Amplication Advanced Solid Tumors With FGFR2 Amplication Advanced Solid Tumors With FGFR3 Mutation

Interventions

  • DRUG BGJ398

Study Locations (20)

California

  • Novartis Investigative Site - Duarte
  • Novartis Investigative Site - Los Angeles
  • Novartis Investigative Site - Los Angeles

Pennsylvania

  • Novartis Investigative Site - Philadelphia
  • Thomas Jefferson University Hospital Onc Dept - Philadelphia
  • Novartis Investigative Site - Pittsburgh

Other

  • Novartis Investigative Site - Vienna
  • Novartis Investigative Site - Bordeaux
  • Novartis Investigative Site - Lyon

New York

  • Memorial Sloan Kettering Cancer Center Onc. Dept.. - New York
  • Novartis Investigative Site - New York

Tennessee

  • Novartis Investigative Site - Memphis
  • Novartis Investigative Site - Nashville

Colorado

  • University of Colorado Dept. of Anschutz Cancer (3) - Aurora

Connecticut

  • Novartis Investigative Site - New Haven

Massachusetts

  • Novartis Investigative Site - Boston

Trial Details

FieldValue
Enrollment Target 208 participants
Start Date 2009-12-11
Est. Completion 2018-10-08
Phase Phase 1

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01004224

The ClinicalTrials.gov registry entry for NCT01004224 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 208 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 6 conditions, with Advanced Solid Tumors With Alterations of FGFR1, 2 and or 3 appearing as the primary indexed condition, and to 1 intervention - of which BGJ398 is the first listed.

NCT01004224 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Pennsylvania, Other.

Frequently Asked Questions

What is clinical trial NCT01004224 about?

NCT01004224 is a clinical study titled "A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies". The study will determine the maximum tolerated dose and thus the recommended phase II dose and schedule of the compound and characterize the safety.

What is the current status of trial NCT01004224?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 208 participants. The study started on 2009-12-11. Estimated completion is 2018-10-08.

What conditions does trial NCT01004224 study?

This clinical trial studies the following conditions: Advanced Solid Tumors With Alterations of FGFR1, 2 and or 3, Squamous Lung Cancer With FGFR1 Amplification, Bladder Cancer With FGFR3 Mutation or Fusion, Advanced Solid Tumors With FGFR1 Amplication, Advanced Solid Tumors With FGFR2 Amplication.

What interventions are being tested in trial NCT01004224?

The interventions under investigation include: BGJ398 (DRUG).

Who is sponsoring clinical trial NCT01004224?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01004224 being conducted?

This trial has 20 study locations across California, Colorado, Connecticut, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Advanced Solid Tumors With Alterations of FGFR1, 2 and or 3

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Squamous Lung Cancer With FGFR1 Amplification

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California

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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.