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Table 6 Summary of BTH1677 pharmacokinetics parameters

From: A randomized, controlled trial evaluating the efficacy and safety of BTH1677 in combination with bevacizumab, carboplatin, and paclitaxel in first-line treatment of advanced non-small cell lung cancer

Parameters Geometric Mean (CV%)
BTH1677/Bevacizumab/
Carboplatin/Paclitaxel
Cycle 1/Day 1 Cycle 3/Day 1
N 53b 42
AUC0–last (μg•hr./mL) 614.6 (52.0) 423.5 (48.1)
AUC0–24 (μg•hr./mL) 399.8 (37.3) 464.4 (38.9)d
AUC0–∞ (μg•hr./mL) 635.9 (49.5)c 518.6 (42.2)e
Cmax (μg/mL) 49.77 (36.1) 60.50 (49.2)
CL (L/h) 0.441 (47.3)c 0.548 (41.6)e
t1/2 (hr) 17.56 (36.9)c 7.17 (35.3)e
tmax (hr)a 2.48 (1.52, 5.90) 2.37 (1.92, 6.88)
Vss (L) 5.37 (42.4)c 4.13 (51.5)e
R (AUC) NA 1.10 (27.3)d
  1. Abbreviations: AUC (0-last) area under the serum concentration-time curve from time 0 to the time of the last measurable concentration, AUC 0–24 area under the serum concentration-time curve from time 0 to 24 h, AUC 0–∞ area under the serum concentration-time curve from time 0 to infinity, C max maximum serum concentration, CL systemic clearance, CV coefficient of variation, hr. hour, L liter, mL milliliter, N overall sample size, NA not applicable, R (AUC) accumulation ratio calculated as AUC0-24 (Cycle 3)/AUC0-24 (Cycle 1), t 1/2 elimination half-life, t max time of maximum concentration, μg microgram, V ss volume of distribution at steady-state
  2. aMedian (range)
  3. bAlthough 2 other patients met the basic criteria for inclusion in the PK population (ie, having at least 75% of the PK measurements available for any particular treatment cycle data set), 2 patients were subsequently excluded from analysis. One patient received a second unplanned BTH1677 infusion on Day 2 of Cycle 1 and a second patient had a longer infusion time (5.58 h) relative to the other patients for Cycle 1/Day 1. Both of these differences were deemed to likely result in PK differences relative to other patients in Cycle 1 and were excluded
  4. cN = 50
  5. dN = 37
  6. eN = 31