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OP PRO00038487-PRISM-1 / SCREENING	

Types:      Research Oncology Treatment
Synonyms:  BASELINE, SCREENING, IND: 141356/PRISM-1

Baseline/Screening( up to 28 days)	Repeat 1 time	Cycle length: 28 days	Baseline(-7 to -1 days)	Perform every 1 day x1			Research tolerance: -0/+0 days	Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --				Screening (-28 to -1)	Perform every 1 day x1			Research tolerance: -28/+0 days	Nursing Orders
  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Informed Consent
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Medical history and demographics
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Disease history and prior anticancer therapies
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Confirmation of eligibility
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Physical exam/symptom-directed.

A complete PE will be performed at Screening and C1D1. However, if the screening PE occurs within 3 days of C1D1, a brief PE based upon any sign/symptoms exhibited by the patient can instead be conducted. Following C1D1, a brief PE based upon sign/symptoms should be performed at all subsequent timepoints unless a full PE is clinically indicated. Height should be measured at Screening only. Physical examination includes weight and BSA calculation on Day 1 of each cycle. Refer to Section 10.1.2 for PE details.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Randomization.

Randomization must occur within 3 days prior to C1D1. Randomization can be done the same day as C1D1 but must be completed prior to dosing
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse events.
Refer to Table 17 for the AE and SAE reporting periods
			Nursing Orders
  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	CA 19-9.

(local laboratory testing)
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Tumor imaging of chest/abdomen/pelvis.

Refer to Section 9.4 for details regarding radiographic imaging methodology. Radiographic imaging performed as standard-of-care prior to obtaining informed consent and within 28 days of the C1D1 do not have to be repeated and can be used as the baseline disease assessment.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Brain imaging.

Brain imaging (brain MRI or CT scan with contrast if a brain MRI is contraindicated) will be conducted at Screening and during treatment only if symptoms are suggestive of the development of brain metastases. Radiographic imaging performed as standard-of-care prior to obtaining informed consent and within 28 days of the C1D1 do not have to be repeated and can be used as the baseline disease assessment. Refer to Section 9.4 for details regarding radiographic imaging methodology.
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, body temperature, heart rate
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Vital signs to be collected are temperature, pulse rate, blood pressure, respiratory rate, and pulse oximetry (while the patient is in a seated position). On days where quemliclustat/placebo is administered, vital signs should be assessed up to 60 minutes prior to as well as 60  (± 10) minutes following the quemliclustat/placebo infusion. On visit days where multiple assessments are planned at the same nominal timepoint, vital signs should be performed first, followed by ECG(s), and then blood draws. Vital signs measurements can be performed at any time during the study if clinically indicated.
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --			Imaging
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Triplicate ECGs will be conducted as described in Section 10.1.3 at Screening and as clinically indicated. If an ECG occurs on the same day as study drug administration, then the ECG will be performed first.
			Labs
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	If screening laboratory tests (including pregnancy testing) occur within 3 days of C1D1, they do not need to be repeated on C1D1. Additionally, safety laboratory tests can be performed up to 3 days prior to any dosing visit. The investigator or qualified designee must review results of all required laboratory tests prior to administration of any study treatment. Refer to Appendix 3 for a list of safety laboratories. If a patient does not satisfy any of the eligibility requirements during the initial screening assessment, any relevant assessment(s) may be repeated as needed during the screening window (Day -28 to Day -1) and prior to submission of the patient's eligibility to the sponsor. Otherwise, the patient will be considered a screen failure.
			Labs
  	HEPATITIS B CORE ANTIBODY IGM	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --		  	HEPATITIS B VIRUS (HBV), QUANTITATIVE, DNA (ABBOTT REALTIME)	Interval: --	Occurrences: --		  	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --		  	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: --	Occurrences: --		  	HUMAN IMMUNODEFICIENCY VIRUS 1 (HIV-1), QUANTITATIVE PCR	Interval: --	Occurrences: --		  	CD 4 SUBSET	Interval: --	Occurrences: --			Labs
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	For women of childbearing potential only, a serum pregnancy test must be performed at Screening and prior to dosing on C1D1. A serum or urine pregnancy test can be performed at all other study visits where pregnancy testing is indicated.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Labs
  	CANCER ANTIGEN 19-9	Interval: --	Occurrences: --