Clinical trial · Interventional
A Phase I Study of Oral BGJ398 in Asian Patients
A Phase I Study of Oral BGJ398 in Asian Patients With Advanced Solid Tumor Having Alterations of the FGF-R Pathway
NCT01697605CI-TRIAL-00048694completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will evaluate safety and tolerability to determine the Maximum tolerated dose (MTD) and/or Recommended dose (RD).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tumor With Alterations of the FGF-R | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BGJ398 | Drug | Infigratinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BGJ398
- description
- Eligible participants received oral BGJ398 once daily or twice daily. Patients may continue treatment with BGJ398 until the patient experiences unacceptable toxicity or progressive disease.
- interventionNames
- Drug: BGJ398
Primary outcomes (1)
- measure
- Incidence rate and category of dose limiting toxicities (DLTs)
- timeFrame
- First cycle of 28 days
- description
- Maximum tolerated dose (MTD) and/or Recommended dose (RD) of single agent oral BGJ398
Secondary outcomes (12)
- measure
- Frequency of all Adverse Events (AEs) and Serious Advers Events (SAEs)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with advanced solid tumors with FGF-R alteration * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Adequate organ function Exclusion Criteria: * Patients with untreated and/or symptomatic metastatic Central Nerve System (CNS) disease * Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.