Table 2 Dosing and DLT summary by patient cohort
Dose level | CP-856,596 | Docetaxel | Axitinib | Patients evaluable for DLT in the dose-escalation cohorts a | Total number of patients | DLT ( n) | Median duration of treatment, months (range) | Median number of cycles administered (range) | Number of patients with dose reduction |
|---|---|---|---|---|---|---|---|---|---|
1 | 60 mg BID | 75 mg m–2 | 0 | 6 | 7 | Febrile neutropenia (1) | 3.45 (0.23–9.21) | 4.0 (1.0–11.0) | 0 |
2 | 100 mg BID | 75 mg m–2 | 0 | 6 | 25 | Febrile neutropenia (1)b Nausea/vomiting (1)b | 1.48 (0.23–8.36) | 2.0 (1.0–11.0) | 0 |
3 | 100 mg BID | 100 mg m–2 | 0 | 6 | 7 | None | 2.07 (0.69–4.84) | 2.0 (1.0–6.0) | 0 |
4 | 60 mg BID | 75 mg m–2 | 5 mg BID | 9 | 9 | Klebsiella pneumonae infection associated with febrile neutropenia (1) Febrile neutropenia (1) | 5.3 (1.97–12.47) | 6.0 (3.0–16.0) | 1 |
