“But I'm wondering if the data is not so great because we
“But I'm wondering if the data is not so great because we selected patients that were too far gone to be saved.”
Not too worried about that…the clinical trial inclusion/exclusion criteria ensure you likely won’t drop dead as soon as you receive your first dose of the trial drug. Here are a few from the protocol:
“Expected survival of at least three months.
No anti-cancer treatment within the last two weeks or at least 5 half-lives prior to treatment (whichever is shorter), except for palliative radiation therapy from which the patient has recovered from all adverse events.
Patients must have adequate organ and bone marrow function within 28 days prior to the first dosing visit, defined as:
i. Acceptable liver function:
Total bilirubin ≤ 1.5 × upper limit of normal (ULN) OR direct bilirubin ≤ ULN for participants with total bilirubin levels > 1.5 × ULN (participants with known Gilbert's disease may enroll with Total bilirubin ≤ 2.5 × ULN AND direct bilirubin is ≤1.5 × ULN) (if liver metastases are present, Total bilirubin ≤2.0 × ULN).
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases).
ii. Acceptable renal function:
a) GFR ≥ 30 mL/min iii. Acceptable hematologic status:
Hemoglobin ≥ 9 g/dL Note: Criteria must be met without packed red blood cell (pRBC) transfusion within the prior 2 weeks. Participants can be on stable dose of erythropoietin (≥ approximately 3 months).
White blood cells > 2500/µL
Absolute neutrophil count > 1500/µL
Platelet count > 100 000/µL.
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
a) No QTC interval exceeding 460 milliseconds (ms) for females, no QTC interval exceeding 450 ms for males.”
8
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