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NCT04233567 · ClinicalTrials.gov registry record · Phase 2
Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations
A Phase 2 study, sponsored by Sameek Roychowdhury.
- Completed
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT04233567: Completed Phase 2 study, sponsored by Sameek Roychowdhury.
NCT04233567 is a Phase 2 study that has completed, run by Sameek Roychowdhury. The registered enrollment target is 17 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04233567, a Phase 2 study, has completed, sponsored by Sameek Roychowdhury.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study Summary
This phase II trial studies how well infigratinib works in treating solid tumors that have spread to other places in the body (advanced or metastatic) in patients with FGFR gene mutations such as FGFR1-3 gene fusions or other FGFR genetic alterations. Mutations are any changes in the genetic material (DNA) of a cell. FGFR proteins are involved in cell division, cell maturation, formation of new blood vessels, wound healing, and bone growth, development, and maintenance. FGFR mutations can cause the FGFR protein to become over-active in diseases such as cancer. Infigratinib may stop the growth of tumor cells by blocking FGFR proteins in these tumors.
Primary Outcome
Assessed by investigator as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. The estimated ORR will be presented along with the corresponding 90% confidence interval for each cohort, based on a binomial distribution. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all non-nodal target lesions; Partial Response (PR), at least a 30% decrease in the sum of diameter of all target lesions; Ov
Interventions
- DRUG Infigratinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2020-01-16 |
| Est. Completion | 2024-12-12 |
| Phase | Phase 2 |
What the finished NCT04233567 record still lists
NCT04233567 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which Infigratinib is the first listed.
NCT04233567 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04233567 about?
NCT04233567 is a clinical study titled "Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations". This phase II trial studies how well infigratinib works in treating solid tumors that have spread to other places in the body (advanced or metastatic) in patients with FGFR gene mutations such as FGFR1-3 gene fusions or other FGFR genetic alterations. Mutations are any changes in the genetic materia...
What is the current status of trial NCT04233567?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2020-01-16. Estimated completion is 2024-12-12.
What interventions are being tested in trial NCT04233567?
The interventions under investigation include: Infigratinib (DRUG).
Who is sponsoring clinical trial NCT04233567?
This trial is sponsored by Sameek Roychowdhury, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04233567's enrollment target sits among peer trials
17 1903rd of 2000 higher than 93 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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