LB-100 Dosage and Schedule Considerations Sample Clauses

LB-100 Dosage and Schedule Considerations. The optimal rate of LB-100 infusion and the dosing schedule are not known. In the Phase 1 trial, as specified per protocol, PK was done was done in three patients at the MTD, 2.33 mg/m2 in 500 mL saline over two hours. Two were sampled day 1 and day 3, and one on day 1 only. Peak plasma concentrations of LB-100 at the end of the infusion (n=5) averaged 150 ng/ml (~ 0.6 uM) and declined rapidly. As expected, at the end of the two-hour infusion in all patients on day 1 infusion, there was no detectable endothall in plasma. In one of two patients, endothall was present at 17.6 ug/mL (~0.1 uM) in the pretreatment sample on day 3 before the 3rd infusion, suggesting that 24 hours after the day 2 infusion, some endothall was still in tissues, compatible with its relatively slow elimination (t ½ ~7 hours) compared to LB-100 with a t 1/2 of less than 1 hour. However, there is no estimate of the concentrations of LB-100 and endothall in tissues and PK studies were not done after infusion of LB-100 over 15 minutes. Based on the above data for this trial and subsequent studies, it is recommended that LB-100 be infused over 15 minutes on days 1 and 3 of the standard carboplatin/etoposide/atezolizumab regimen to maximize peak plasma concentration and to avoid tissue accumulation of the active metabolite, endothall, which is now known to have a plasma half-life of up to 7 hours. Thus, the Investigator Brochure may be updated during the course of this study with additional risks and benefits. Please see the current Investigator Brochure for further details about the potential risks and benefits associated with this study. In the Phase 1 trial of LB-100 in solid tumor patients, three patients received a dose of 1.75 mg/m2 in 50 mL normal saline over 15 minutes daily for three consecutive days without any significant toxicity. In the present trial the starting dose of LB-100 is 1.75 mg/m2 in 50 mL normal saline on day 1 and day 3. Thus, we anticipate no toxicity attributable to LB-100 itself, allowing recognition of any potentiation of the standard toxicities associated with the other agents. LB-100 is supplied as a sterile solution for intravenous administration. LB-100 is stored at -20C (range: - 25C to -10C). Each vial contains LB-100 at a concentration of 1 mg/mL. The proper dose is drawn up in a sterile syringe and added to 50 mL of normal saline (0.9%) and infused over 15 +/- 5 minutes. Following dilution in normal saline, LB-100 should be administered within 4 hours.
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