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OP RESEARCH PRO00038299 / NIRAVATH BEAMICON BCGC-1 SCREENING	

Types:      Research Oncology Treatment
Synonyms:  ZONGERTINIB, B1 1810631, TRASTUZUMAB DERUXTECAN, T-DXD, TRASTUZUMAB EMTANSINE, T-DM1, HER2+, ADENOCARCINOMA, METASTATIC, BREAST, GASTRIC, GASTROESOPHAGEAL JUNCTION, ESOPHAGEAL ADENOCARCINOMA, MGEAC

Cycle 1	Repeat 1 time	Cycle length: 28 days	Day -28	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	After Consenting, subjects must meet the following parameters:
·  Documented HER2+ mBS or mGEAC according to ASCO-CAP guidelines.
·  Life expectancy of at least 12 weeks at the start of treatment in the opinion of the investigator.
·  ECOG score of 0 or 1.
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Inclusion criteria:
·       ANC GREATER than or EQUAL 1.5x 109/L (GREATER than or EQUAL 1.5x 103/ul)(GREATER than or EQUAL 1500/mm3).
·	Platelets GREATER than or EQUAL 100x 109/L (100x 103/ul)(100x 103/mm3).
·	HGB GREATER than or EQUAL 9.0 d/dL.
·	Total bilirubin LESS than or EQUAL 1.5 x ULN.
·	GFR GREATER than or EQUAL 30mL/min.
·	AST/ALT LESS than or EQUAL 2.5x ULN.
·	Alkaline phosphatase LESS than 5x ULN.
·	PTT/aPTT LESS than 1.5x ULN.
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Exclusion criteria:
·	CHF per NYHA classification of GREATER than or EQUAL III or IV.
·	Unstable angina.
·	Myocardial infarction within 28 days of randomization.
·	Mean resting QT interval GREATER than 470 msec.
·	EF LESS than 50% .
·	History of HIV who meet one or more of the following criteria.
o	CD4+ count LESS than 350 cells/uL.
o	Viral load GREATER than 400 copies/mL.
o	Not receiving antiretroviral therapy.
o	History of AIDS-defining opportunistic infections within 12 months prior to start of trial treatment.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	ECOG performance status.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Done in triplicates after 5 minutes of resting.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	RETICULOCYTE COUNT	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	If total bilirubin is elevated.
		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	URINALYSIS SCREEN AND MICROSCOPY, WITH REFLEX TO CULTURE	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
			Labs
  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --		  	HEPATITIS B CORE ANTIBODY IGM	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIBODY	Interval: --	Occurrences: --		  	HEPATITIS C VIRUS (HCV) ANTIBODY WITH REFLEX TO PCR	Interval: --	Occurrences: --			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --		  	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Only if there was brain metastasis at screening.
			Nuclear Medicine
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Bone imaging if clinically indicated (the same imaging technique must be used throughout the trial).
			Cardiology
  	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	Performed every fourth cycle.
			Procedures
  	BIOPSY	Interval: --	Occurrences: --	Comments:	Tumor biopsy only in Phase II (only if there is not archival tissue).