Table 3.

Drug administration and toxicities

A. Phase I dose-escalation cohorts
Dose level (μg/kg)No. patientsNo. doses (course 1)
DLTs (no. doses)*,,Other events, dose limiting but not related to BAY 50-4798
2825-2719-24<19
1.333
2.6431 (24)Progressive malignant pleural effusion
5.244
10.462211See Table 3B
17.4742 (25, 25)1 (2)Atrial fibrillation (2); creatinine (28); hypotension (25)
26.1642 (20, 14)Hypotension; creatinine (20); ulcer/gastrointestinal bleed (14)
B. Extension at the MTD level of 10.4 μg/kg, all 21 RCC patients
No. doses (course 1)
No. patients
DLTs (no. doses)
Other events, dose limiting but not related to BAY 50-4798
2810Atrial fibrillation, 1 patient
25-2751-3 doses withheld for multiple grade 2 toxicities
19-243Rash (23)
Fatigue (21)
<193Urticaria (10)Cerebrovascular ischemia (12)
Hypotension (17)
  • NOTE: Numbers in parentheses denote the number of doses of Bay 50-4798 administered.

  • * Defined as grade 3 treatment-related toxicities that led to withholding one or more doses of BAY 50-4798 or that occurred after all 28 doses in course.

  • No grade 4 toxicities occurred.

  • Dose withholding for multiple grade 2 toxicities was not reportable.