EUCTR2014-002929-35-DE进行中（未招募）1 期
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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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. FGF401 single agent-Phase II, Group 3: 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. FGF401 single agent 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. FGF401 single agent 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.
- •8. FGF401 in combination with PDR001-PhaseI and Phase II: Advanced HCC patients who have received up to 2 previous lines of systemic
- •treatment and one treatment must have included sorafenib with documented disease progression during or after discontinuation of sorafenib treatment, or intolerance to sorafenib treatment.
- •9. FGF401 in combination with PDR001-Phase II-Stage 2: Documented FGF19 expression level and/or FGF19 pathway activation
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •1. Previous treatment with a FGF19-FGFR4 targeting therapy.
- •2. For HCC patients in FGF401 single agent 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 > 1.5 x ULN
- •AST and/or ALT > 3 x ULN
- •Serum creatinine > 1.5 x ULN and/or creatinine clearance < 40 mL/min
- •Coagulation: PT > 4 seconds more than the ULN or INR > 1.7
- •7. Unable to stop any prohibited medications, including CYP1A2, CYP2C9 and CYP3A4/5 substrates with a narrow therapeutic index and known BSEP efflux transporter inhibitors.
- •8. Additional exclusion criteria for FGF401 and PDR001 combination:
- •- Impaired cardiac function
- •- History of liver or other organ transplantation
- •- Patients who discontinued prior anti-PD-1/PD-L1 therapy due to an anti PD-1/PD-L1-related toxicity
- •Other protocol-defined exclusion criteria may apply.
研究者
相似试验
进行中（未招募）
1 期
Study of oral FGF401 in adult patients with liver cancer or other types of cancerHepatocellular carcinoma or other solid tumors characterized by positive FGFR4 and KLB expressionMedDRA version: 17.1 Level: LLT Classification code 10065252 Term: Solid tumor System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.1 Level: PT Classification code 10073071 Term: Hepatocellular carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-002929-35-FRovartis Pharma Services AG130
进行中（未招募）
1 期
Study of oral FGF401 in adult patients with liver cancer or other types of cancerEUCTR2014-002929-35-ESovartis Farmacéutica, S.A.130
进行中（未招募）
1 期
A clinical study to investigate the safety and efficacy of RXDX-101 in patients with locally Advanced or Metastatic CancerEUCTR2014-001326-15-ESIgnyta Inc.83
进行中（未招募）
不适用
A clinical study to investigate the safety and efficacy of RXDX-101 in patients with locally Advanced or Metastatic Cancerocally advanced or metastatic solid tumorsMedDRA version: 17.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864MedDRA version: 17.1Level: LLTClassification code 10065143Term: Malignant solid tumourSystem Organ Class: 100000004864EUCTR2014-001326-15-GBIgnyta, Inc.160
进行中（未招募）
不适用
An Open Labelled, Clinical Phase II Study With Oral Cis-U-Hydroxy-L-Proline (CHP) in 45 Patients With:- Chronic viral hepatitis- Chronic alcoholic liver diseases without cirrhosis- Compensated alcoholic liver cirrhosis- Primary Billiary Cirrhosis or Primary Sclerosing Cholangitis - B025-L CHP Chronic liver diseaseChronic viral hepatitis, Chronic alcoholic liver diseases without cirrhosis, Compensated alcoholic liver cirrhosis, Primary Billiary Cirrhosis or Primary Sclerosing CholangitisMedDRA version: 1.1Level: SOCClassification code 10019805EUCTR2005-001454-24-LTRIEMSER Arzneimittel AG45