Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04265651 · ClinicalTrials.gov registry record · Phase 2
Study of Infigratinib in Children With Achondroplasia
A Phase 2 study, sponsored by QED Therapeutics, a BridgeBio company.
- Completed
- Registry status
- Phase 2
- Development phase
- 84
- Enrollment target
NCT04265651 is a Phase 2 study that has completed, run by QED Therapeutics, a BridgeBio company. The registered enrollment target is 84 participants.
The verdict
NCT04265651, a Phase 2 study, has completed, sponsored by QED Therapeutics, a BridgeBio company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 84 participants
- Enrollment target
Study Summary
This is a Phase 2, multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, and efficacy of infigratinib, a fibroblast growth factor receptor (FGFR) 1-3-selective tyrosine kinase inhibitor, in children 3 to 11 years of age with Achondroplasia (ACH) who previously participated in the PROPEL study (Protocol QBGJ398-001) for at least 6 months. The study includes dose escalation with extended treatment, and dose expansion. The study also includes a PK Substudy to fully characterize the pharmacokinetics of infigratinib in children with ACH.
Interventions
- DRUG Infigratinib 0.016 mg/kg
- DRUG Infigratinib 0.032 mg/kg
- DRUG Infigratinib 0.064 mg/kg
- DRUG Infigratinib 0.128 mg/kg
- DRUG Infigratinib 0.25 mg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2020-03-10 |
| Est. Completion | 2024-10-21 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04265651
The ClinicalTrials.gov registry entry for NCT04265651 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is QED Therapeutics, a BridgeBio company, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Infigratinib 0.016 mg/kg is the first listed.
NCT04265651 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04265651 about?
NCT04265651 is a clinical study titled "Study of Infigratinib in Children With Achondroplasia". This is a Phase 2, multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, and efficacy of infigratinib, a fibroblast growth factor receptor (FGFR) 1-3-selective tyrosine kinase inhibitor, in children 3 to 11 years of age with Achondroplasia (ACH) who ...
What is the current status of trial NCT04265651?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2020-03-10. Estimated completion is 2024-10-21.
What interventions are being tested in trial NCT04265651?
The interventions under investigation include: Infigratinib 0.016 mg/kg (DRUG), Infigratinib 0.032 mg/kg (DRUG), Infigratinib 0.064 mg/kg (DRUG), Infigratinib 0.128 mg/kg (DRUG), Infigratinib 0.25 mg/kg (DRUG).
Who is sponsoring clinical trial NCT04265651?
This trial is sponsored by QED Therapeutics, a BridgeBio company, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
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.