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Table 8 Correlations between drug exposure and toxicity, normalised drug exposure and creatinine clearance (Spearman rank order analysis).

From: A phase I trial of PR-104, a pre-prodrug of the bioreductive prodrug PR-104A, given weekly to solid tumour patients

Exposure

platelets†

neutrophils†

CrCl‡

Dose

-0.79 (2 × 10-7)

-0.56 (5 × 10-3)

-

PR-104 AUC

-0.56 (0.005)

-0.35 (0.1)

-0.14 (0.52)

PR-104A AUC

-0.75 (2 × 10-7)

-0.49 (0.02)

-0.12 (0.59)

PR-104G AUC

-0.51 (0.01)

-0.13 (0.56)

-0.01 (0.98)

PR-104(H+M) AUC

0.09 (0.67)

-0.04 (0.84)

-0.04 (0.86)

PR-104S1 AUC

-0.61 (0.002)

-0.53 (0.009)

-0.16 (0.46)

  1. †At nadir (percentage of pretreatment value)
  2. ‡Creatinine clearance. Drug exposures (AUC) are normalised by dose levels.
  3. Values are correlation coefficient and (p value).