PF-06463922 for crizotinib pretreated ROS1 positive non-small-cell lung cancer: a phase II Trial (PFROST) - PFROST

FONDAZIONE RICERCA TRASLAZIONALE (FORT)0 个研究点目标入组 20 人开始时间: 2021年1月7日最近更新: 2021年7月12日

适应症

试验速览

暂无简介。

•1.Written informed consent;
•2.Male or female patient ages = 18 years;
•3.Histologically/cytologically confirmed diagnosis of NSCLC with evidence of ROS1 rearrangement;
•4.Possibility to perform a new tumor biopsy or tumor tissue collected at the time or after crizotinib failure;
•5.Patient pretreated with crizotinib with evidence of disease progression during crizotinib therapy;
•6.At least one radiological measurable disease according to RECIST criteria;
•7.At least 1 previous standard chemotherapy regimen;
•8.Performance status 0-2 (ECOG);
•9.Patient compliance to trial procedures
•10.Adequate bone marrow function (ANC = 1.5x109/L, platelets = 100x109/L, haemoglobin > 9 g/dl);
•11.Adequate liver function (bilirubin < grade 2, transaminases no more than 3xULN/<5xULN in present of liver metastases);
•12.Normal level of alkaline phosphatase and creatinine;
•13.If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of approved contraceptive method [intrauterine contraceptive device (IUD), birth control pills, or barrier device] during and for ninety (90) days after end of treatment.
•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 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•1.No ROS1 rearrangement
•2.No previous therapy with crizotinib;
•3.No evidence of crizotinib failure;
•4.No post-crizotinib tumor tissue available;
•5.Absence of any measurable lesions;
•6.No previous chemotherapy;
•7.Concomitant radiotherapy or chemotherapy;
•8.Symptomatic brain metastases;
•9.Diagnosis of any other malignancy during the last 5 years, except for in situ carcinoma of cervix uteri and squamous cell carcinoma of the skin;
•10.Predisposing factors for acute pancreatitis (e.g., uncontrolled hyperglycaemia, current gallstone disease, alcoholism);
•11.History of extensive disseminated/bilateral or known presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease including a history of pneumonitis, hypersentivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis and pulmonary fibrosis (but not history of prior radiation pneumonitis);
•12.Pregnancy or lactating female;
•13.Other serious illness or medical condition potentially interfering with the study.

发起方

FONDAZIONE RICERCA TRASLAZIONALE (FORT)