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Table 2 Patients treated and DLTs by dose level

From: Phase I study of oral ridaforolimus in combination with paclitaxel and carboplatin in patients with solid tumor cancers

Dose Level Ridaforolimus
mg (days of cycle)
Carboplatin (AUC) No. of Patients Enrolled No of Patients evaluable for DLTa Dose-Limiting Toxicity
1 10 (days 1–5, 8–12, 15–19) 5 4 4 Two grade 4 neutropenia
1A 10 (days 1–5, 8–12) 5 6 6 Death from sepsis
2A 20 (days 1–5, 8–12) 5 4a 3 None
3A 30 (days 1–5, 8–12) 5 3 3 None
4A 30 (days 1–5, 8–12) 6 7b 6 Grade 3 mucositis; grade 4 thrombocytopenia requiring transfusion
  1. Slots replaced due to aprotocol non-compliance or bnon-treatment related issue
  2. Paclitaxel was at 175 mg/m2 for all cohorts