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 - A phase I study with BGJ398 (pan FGF-R inhibitor) in solid malignancies.

ovartis0 个研究点目标入组 13 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•1. Patients with histologically/cytologically confirmed advanced solid tumors with FGFR1 or FGFR2 amplification or FGFR3 mutation, for which no further effective standard anticancer treatment exits. Patients with advanced solid tumors carrying any FGFR mutation or amplification identified locally may be enrolled
•2. Measurable or non-measurable disease, for arm 4 measurable disease
•3. * 18 years of age.
•4. WHO performance status 0-2.
•5. Adequate bone marrow function:
•6. Adequate hepatic and renal function:
•7. Calcium-phosphate homeostasis:
•* Normal serum inorganic phosphorus (Pi).
•* Normal serum total (t) and ionized (i) calcium (Ca).
•8. Adequate cardiovascular function
•* NYHA grade * 2.
•* Ejection fraction * 50%.
•* QTc interval * 470 msec.
•* BP systolic in rest * 100 mmHg and * 150 mmHg.
•* BP diastolic in rest * 100 mmHg.
•* Heart rate in rest > 50/min and < 100/min.
•9. Recovery from all adverse events of previous systemic anti-cancer therapies to Grade * 1 except for alopecia and stable neuropathy of Grade *2 which was induced by prior cancer treatment.
•10. Contraception:
•* Women of childbearing potential and men must use adequate contraceptive regimen during and for 3 months after the treatment period; women must have a negative pregnancy test and must not be nursing.
•* For men must use adequate contraceptive regimen during and for 3 months after the treatment period.

•1. Prior treatment with FGFR-inhibitor or MEK-inhibitor with the exception of prior treatment with TKI258.
•2. Patients with primary CNS tumor or CNS tumor involvement.
•3. Patients with history and/or current evidence of endocrine alteration of calcium/phosphate
•homeostasis
•4. History and/or current evidence of ectopic mineralization/ calcification with the exception of calcified lymphnodes and asymptomatic coronary calcification.
•5. Current evidence of corneal disorder/ keratopathy
•6. Concomitant therapies that are known to prolong the QT interval and/or are associated with a risk of Torsades de Pointes < 7 days before the first dose; however amiodarone is not permitted <90 days before the first dose.
•7. Medication or supplements to increase serum levels of phosphorus and/or calcium levels within 28 days before the first dose.
•8. Active or unstable cardio/cerebro-vascular disease.
•9. History or current evidence of cardiac arrhythmia and/or conduction abnormality CTCAE Grade * 1.
•10. History of congenital long QT- syndrome and/or hypokalaemia CTCAE Grade * 3.
•11. Chest x-ray/CT with evidence of lung calcifications with the exception of calcified

发起方