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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: Completed 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.
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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (247% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Incidence rate and category of dose-limiting toxicities will be tabulated for patients included in the dose escalation portion of the study, to establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPTD). This will be calculated using an established statistical model, based on incidence of adverse events and serious adverse events, physical examinations, vital signs, electrocardiograms, and laboratory parameters
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 208 participants |
| Start Date | 2009-12-11 |
| Est. Completion | 2018-10-08 |
| Phase | Phase 1 |
What the finished NCT01004224 record still lists
NCT01004224 is an interventional study that assigns participants to a tested intervention. The registered 208 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (247% higher).
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 names 20 study sites across 12 states, led by 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01004224's enrollment target sits among peer trials
208 250th of 2000 higher than 1,749 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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