A Phase 1 interventional study of BGJ398 in Advanced Solid Tumors With Alterations of FGFR1, 2 and or 3, Squamous Lung Cancer With FGFR1 Amplification and Bladder Cancer With FGFR3 Mutation or Fusion, sponsored by Novartis Pharmaceuticals. Completed at 50 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-04.
Sponsored by Novartis Pharmaceuticals · Phase 1, Interventional, and Treatment
The study will determine the maximum tolerated dose and thus the recommended phase II dose and schedule of the compound and characterize the safety.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 208 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
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Contraception.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Drug: BGJ398
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)
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
Time frame: 23 months
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)
overall response rate (ORR), as assessed by investigator per RECIST v 1.0; overall survival (OS), duration of response (DOR) and disease control rate (DCR) will be assessed
Time frame: 23 months
To determine the pharmacokinetic (PK) profiles of oral BGJ398
Time vs. concentration profiles, PK parameters of BGJ398 and known active metabolite(s).
Time frame: 23 months
To evaluate the pharmacodynamic effect of the drug.
Pre- vs. post treatment serial changes in FGF23 plasma levels (not done for patients enrolled to expansion Arm 4)
Time frame: 23 months
Assess preliminary anti-tumor activity for patients not in Arm 4.
Overall tumor response rate (ORR) and PFS assessed by investigator per RECIST
Time frame: 23 months
Plan to share: No
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This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals