Table 2 Dose escalation, exposure and dose-limiting toxicity

From: A phase I study of the safety and pharmacokinetics of the histone deacetylase inhibitor belinostat administered in combination with carboplatin and/or paclitaxel in patients with solid tumours

Cohort

Belinostat day 1–5 (mg m−2)

Carboplatin day 3 (AUCa)

Paclitaxel day 3 (mg m−2)

No. of patients b

Total no. of completed cycles

Median no. of completed cycles (range)

Dose-limiting toxicity

1A

600

5

—

5

25

4 (1–12)

—

1B

600

—

175

5

40

6 (0–20)

—

2

600

5

175

3

9

2 (1–6)

—

3

800

5

175

4

36

2 (0–32)

—

4

1000

5

175

6

29

5 (2–9)

—

  1. Abbreviations: AUC=area under curve; EDTA=ethylenediaminetetraacetic acid; GFR=glomerular filtration rate.
  2. aCalvert formula using chrome-EDTA clearance to estimate GFR.
  3. bPatients who did not complete the first cycle were replaced.
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