EUCTR2017-003507-22-HU进行中（未招募）1 期
A Phase 3 Randomized, Double-Blind, Controlled Study Evaluating FPA144 and Modified FOLFOX6 in Patients with Previously Untreated Advanced Gastric and Gastroesophageal Cancer: Phase 3 Preceded by Dose-Finding in Phase 1 - FIGHT
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 548
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
入选标准
- •Phase 1 and Phase 3:
- •1. Disease that is unresectable, locally advanced, or metastatic (not amenable to curative therapy)
- •2. Understand and sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved ICF prior to any study-specific evaluation
- •3. Life expectancy of at least 3 months in the opinion of the investigator
- •4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- •5. Age = 18 years at the time the ICF is signed
- •6. In sexually active patients (women of child bearing potential [WOCBP] and males), willingness to use 2 effective methods of contraception, of which 1 must be a physical barrier method (condom, diaphragm, or cervical/vault cap) until 6 months after the last dose of FPA144. Other effective forms of contraception include:
- •Permanent sterilization (hysterectomy and/or bilateral oophorectomy, or bilateral tubal ligation with surgery, or vasectomy) at least 6 months prior to screening
- •WOCBP who are on stable oral contraceptive therapy or intrauterine or implant device for at least 90 days prior to the study, or abstain from sexual intercourse as a way of living
- •7. Adequate hematological and biological function, confirmed by the following laboratory values within 96 hours prior to enrollment:
- •Bone Marrow Function
- •ANC = 1.5 × 109/L
- •Platelets = 100 × 109/L
- •Hemoglobin = 9 g/dL
- •Hepatic Function
- •AST and ALT < 3 × ULN; if liver metastases, then < 5 × ULN
- •Bilirubin < 1.5 × ULN except in patients with Gilbert’s disease
- •Renal Function
- •Calculated CrCl using Cockroft Gault formula = 50 mL/min
- •8. INR or prothrombin time (PT) < 1.5 × the ULN except for patients receiving anticoagulation, who must be on a stable dose of warfarin for 6 weeks prior to enrollment
- •9. Measurable or non-measurable, but evaluable disease using RECIST v1.1
- •Additional Inclusion Criteria for Phase 3 Only:
- •Histologically documented gastric or gastroesophageal junction (GEJ) adenocarcinoma (not amenable to curative therapy)
- •Radiographic imaging of the chest, abdomen and pelvis (computed tomography [CT] preferred, magnetic resonance imaging [MRI] acceptable) performed within 28 days (± 3 days) of treatment (C1D1)
- •FGFR2b overexpression as determined by a centrally performed IHC tissue test and/or FGFR2 gene amplification as determined by a centrally performed ctDNA blood based assay
- •Patient must be a candidate for mFOLFOX6 chemotherapy
- •No prior chemotherapy for metastatic or unresectable disease (except a maximum of 1 dose of mFOLFOX6 administered while waiting for results of FGFR2 testing during the Pre-Screening period)
- •If prior adjuvant or neo-adjuvant therapy (chemotherapy and/or chemoradiation) has been received, more than 6 months must have elapsed between the end of adjuvant therapy and the confirmation of radiographic disease progression
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
排除标准
- •Phase 1 and Phase 3:
- •1. Untreated or symptomatic central nervous system (CNS) metastases (CNS imaging not required). Patients with asymptomatic CNS metastases are eligible provided they have been clinically stable for at least 4 weeks and do not require intervention such as surgery, radiation, or any corticosteroid therapy for management of symptoms related to CNS disease
- •2. Impaired cardiac function or clinically significant cardiac disease, including any of the following (Criteria a through g):
- •a) Unstable angina pectoris = 6 months prior to enrollment
- •b) Acute myocardial infarction = 6 months prior to enrollment
- •c) New York Heart Association Class II-IV congestive heart failure
- •d) Uncontrolled hypertension (as defined as = 160/90 despite optimal medical management)
- •e) Uncontrolled cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin
- •f) Active coronary artery disease
- •g) Fridericia’s correction formula (QTcF) = 480
- •3) Peripheral sensory neuropathy = CTCAE Grade 2
- •4. Active infection requiring systemic treatment or any uncontrolled infection =14 days prior to enrollment
- •5. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or known active or chronic hepatitis B or C infection
- •6. History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis)
- •7. Evidence or history of bleeding diathesis or coagulopathy
- •8. Radiotherapy = 28 days of enrollment. Patients must be recovered from all acute radiotherapy-related toxicities. No radiopharmaceuticals (strontium, samarium) within 8 weeks of enrollment
- •9. Prior treatment with any selective inhibitor (eg, AZD4547, BGJ398, JNJ-42756493, BAY1179470) of the FGF-FGFR pathway
- •10. Ongoing adverse effects from prior systemic treatment > NCI CTCAE Grade 1 (with the exception of Grade 2 alopecia)
- •11. Participation in another therapeutic clinical study or receiving any investigational agent within 28 days of enrollment or during this clinical study
- •12. Corneal defects, corneal ulcerations, keratitis, keratoconus, history of corneal transplant, or other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer
- •13. Known positivity for HER2 (as defined by a positive IHC test of 3+ or IHC of 2+ with fluorescent in situ hybridization [FISH])
- •14. Major surgical procedures not permitted = 28 days prior to enrollment. Surgery requiring local/epidural anesthesia must be completed at least 72 hours before enrollment. In all cases, the patient must be sufficiently recovered and stable before treatment administration
- •15. Women who are pregnant or breastfeeding (unless the patient is willing to interrupt breastfeeding during study treatment administration and then resume 6 months after study discontinuation); WOCBP must not consider getting pregnant during the study
- •16. Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (eg, substance abuse, psychiatric disturbance, uncontrolled intercurrent illness including arteria
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