Evaluation of Clinical Utility of CANscript after Comprehensive Genomic Profiling using Foundation One, in Predicting the Treatment Response During the Routine Clinical Management of Patients with Advanced, Relapsed or Refractory Solid Tumors - PREDICT One

Dr Amit Verma0 个研究点目标入组 5 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•1.Male or female patient Ã¢â?°Â¥18 years of age.
•2.Histologically- or cytologically-confirmed advanced, relapsed or refractory solid tumors.
•3.Patients with known comprehensive genomic profiling evaluation using Foundation One within 6 months of enrolment in the study. This timeframe can be extended for up to one year if the patient has not received the active treatment as suggested by the comprehensive genomic profiling evaluation.
•4.PatientÃ¢â?¬•s tumor amenable to a tumor biopsy sampling, so that CANscript can be performed.
•5.ECOG 0-2.
•6.Patient with measurable tumor target lesion as per RECIST1.1 criteria at baseline.
•7.Patient willing to provide informed consent prior to participation in study.

•1.Presence of an additional active malignancy that may confound the assessment of the study endpoints.
•2.Presence of clinically significant cardiovascular disease (e.g., uncontrolled or any New York Heart Association Class 3 or 4 congestive heart failure, uncontrolled angina, history of myocardial infarction, unstable angina or stroke within 6 months prior to study entry, uncontrolled hypertension or clinically significant arrhythmias not controlled by medication).
•3.Presence of known active or suspected brain metastases.
•4.Presence of uncontrolled intercurrent illness.
•5.Female patient having known positive status for pregnancy or breast feeding.
•6.The patient has known positive status for human immunodeficiency virus active or chronic Hepatitis B or Hepatitis C.
•7.Participation in another research study within a period of 30 days prior to the date of enrollment.

发起方

Dr Amit Verma