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NCT03773302 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations
A Phase 3 study, sponsored by QED Therapeutics, a BridgeBio company.
- Terminated
- Registry status
- Phase 3
- Development phase
- 48
- Enrollment target
NCT03773302 is a Phase 3 study that was terminated before completion, run by QED Therapeutics, a BridgeBio company. The registered enrollment target is 48 participants.
The verdict
NCT03773302, a Phase 3 study, was terminated before completion, sponsored by QED Therapeutics, a BridgeBio company.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 48 participants
- Enrollment target
Study Summary
Infigratinib is an oral drug which selectively binds to fibroblast growth factor receptor (FGFR) 2 and is being developed to treat participants with FGFR2 mutated cholangiocarcinoma. The purpose of the study is to evaluate the efficacy and safety of the investigational agent oral infigratinib vs standard of care chemotherapy (gemcitabine plus cisplatin) in first-line treatment of participants with unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion/rearrangement. Subjects will be randomized 2:1 to receive infigratinib or gemcitabine plus cisplatin.
Interventions
- DRUG Cisplatin
- DRUG Gemcitabine
- DRUG BGJ398
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2019-12-27 |
| Est. Completion | 2023-03-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03773302
The ClinicalTrials.gov registry entry for NCT03773302 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 48 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 3 interventions - of which Cisplatin is the first listed.
NCT03773302 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03773302 about?
NCT03773302 is a clinical study titled "Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations". Infigratinib is an oral drug which selectively binds to fibroblast growth factor receptor (FGFR) 2 and is being developed to treat participants with FGFR2 mutated cholangiocarcinoma. The purpose of the study is to evaluate the efficacy and safety of the investigational agent oral infigratinib vs sta...
What is the current status of trial NCT03773302?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 48 participants. The study started on 2019-12-27. Estimated completion is 2023-03-02.
What interventions are being tested in trial NCT03773302?
The interventions under investigation include: Cisplatin (DRUG), Gemcitabine (DRUG), BGJ398 (DRUG).
Who is sponsoring clinical trial NCT03773302?
This trial is sponsored by QED Therapeutics, a BridgeBio company, which has 8 total clinical trials registered on ClinicalTrials.gov.
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