Clinical trial · Interventional
A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies
A Phase I, Open-label, Multi-center, Dose Escalation Study of Oral BGJ398, a Pan FGF-R Kinase Inhibitor, in Adult Patients With Advanced Solid Malignancies
NCT01004224CI-TRIAL-00041008completedPhase 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)
The study will determine the maximum tolerated dose and thus the recommended phase II dose and schedule of the compound and characterize the safety.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors With Alterations of FGFR1, 2 and or 3 | — | UNRESOLVED | — |
| Advanced Solid Tumors With FGFR1 Amplication | — | UNRESOLVED | — |
| Advanced Solid Tumors With FGFR2 Amplication | — | UNRESOLVED | — |
| Advanced Solid Tumors With FGFR3 Mutation | — | UNRESOLVED | — |
| Bladder Cancer With FGFR3 Mutation or Fusion | — | UNRESOLVED | — |
| Squamous Lung Cancer With FGFR1 Amplification | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BGJ398 | Drug | Infigratinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BGJ398
- interventionNames
- Drug: BGJ398
Primary outcomes (1)
- measure
- 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)
- timeFrame
- 23 months
- description
- 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
Secondary outcomes (4)
- measure
- To assess preliminary anti-tumor activity of BGJ398 for patients in expansion Arm 4 (previously treated patients with advanced/metastatic UCC with FGFR3 gene alterations)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically/cytologically confirmed advanced solid tumors with FGFR1 or FGFR2 amplification or FGFR3 mutation, for which no further effective standard anticancer treatment exists * Adequate bone marrow function * Adequate hepatic and renal function * Adequate cardiovascular function * Contraception. * For women: Must be surgically sterile, post-menopausal, or compliant with a medically approved contraceptive regimen during and for 3 months after the treatment period; must have a negative serum or urine pregnancy test and must not be nursing. * For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 3 months after the treatment period Exclusion Criteria: * Patients with primary CNS tumor or CNS tumor involvement * Patients with history and/or current evidence of endocrine alteration of calcium-phosphate homeostasis * History and/or current evidence of ectopic mineralization/ calcification including but not limited to the soft tissue, kidneys, intestine, myocard and lung with the exception of calcified lymphnodes and asymptomatic coronary calcification * Current evidence of corneal disorder/ keratopathy incl. but not limited to bullous/ band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis etc., confirmed by ophthalmologic examination. * History or current evidence of cardiac arrhythmia and/or conduction abnormality * Women who are pregnant or nursing. Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available
No reference posted for this study.