A phase I/II, multicenter, open-label study of oral FGF401 in adult patients with hepatocellular carcinoma or solid malignancies characterized by positive FGFR4 and KLB expression

ovartis Pharma Services AG0 个研究点目标入组 130 人开始时间: 2015年1月22日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•1. Patients (male or female) = 18 years of age
•2. ECOG Performance Status = 1
•3. Presence of at least one measurable lesion according to RECIST v1.1.
•4. Patients with confirmed positive expression of FGFR4 and KLB at pre-screening.
•5. For HCC patients: the diagnosis must be made based on AASLD Guidelines with confirmed stage C advanced HCC (BCLC staging classification). Current cirrhotic status of Child-Pugh class A (5-6 points), with no encephalopathy and/or ascites.
•6. Phase I: Patients with HCC or advanced solid tumors, who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists.
•7. Phase 2: HCC patients previously treated with sorafenib for advanced HCC with documented disease progression during or after discontinuation of sorafenib treatment, or intolerance to sorafenib treatment.
•Other protocol-defined inclusion criteria may apply.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 65
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 65

•1. Previous treatment with a FGF19-FGFR4 targeting therapy.
•2. For HCC patients in Phase II part: any previous systemic anti-cancer therapies other than sorafenib or any anti-cancer therapy (including locoregional therapy) after disease progression during or after sorafenib treatment.
•3. Ongoing active diarrhea requiring medications (e.g. BAS, loperamide)
•4. Irritable bowel syndrome with signs/symptoms and requires medications
•5. Symptomatic CNS metastases which are neurologically unstable or requiring increasing doses of steroids to control their CNS disease.
•6. Patient having out of range laboratory values defined as:
•Hematology
•Hemoglobin = 9 g/dL (SI Units: 90 g/L)
•Platelet count < 75000/mm3
•Absolute neutrophil count (ANC) < 1500/mm3
•Chemistry
•Total bilirubin = 2 mg/dL
•AST and/or ALT > 3 x ULN
•Serum creatinine > 1.5 x ULN and/or creatinine clearance = 45 mL/min
•Coagulation: PT = 4 seconds or INR = 1.7
•7. Unable to stop any prohibited medications, including CYP1A2, CYP2C9 and CYP3A substrates with a narrow therapeutic index, long acting proton pump inhibitors, and strong BSEP efflux transporter inhibitors.
•Other protocol-defined exclusion criteria may apply.

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