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Table 2 Dose escalation scheme, treatment delivery and cycle-one dose-limiting toxicity (DLTs)

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

Cohort Number Dose level (mg/m2/wk) Dose increment Number of patients Total number of cycles (median per patient) Total number of infusions (median per patient) Number of patients with cycle-one DLT
1 135 - 3 9 (2) 32 (6) 0
2 270 100% 6 17 (2) 50 (6) 0
3 540 100% 6 11 (2) 30 (5) 1a
4 675 25% 7 12 (2) 33 (5) 0
5 900 33% 4 6 (1.5) 15 (4) 2b
  1. agrade 4 thrombocytopenia; bgrade 4 thrombocytopenia and grade 4 neutropenia lasting > 5 day