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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