Table 1.
Dose escalation scheme and cycle 1 dose-limiting events (DLTs).
| Dose Level | Lonafarnib | Gemcitabine* | No. Patients | No. Patients with DLTs |
DLT events |
|---|---|---|---|---|---|
| −1 | 100 mg BID | 750 mg/m2 | 4 | 0 | - |
| 1 | 150 mg BID | 750 mg/m2 | 4 | 2 | Grade 3 headache, anorexia, nausea, and vomiting. |
| Grade 3 anorexia, diarrhea, dehydration, and fatigue | |||||
| Intermediate | |||||
| A | 100 mg BID | 1000 mg/m2 | 3 | 0 | - |
| B | 150 mg AM, 100 mg PM | 1000 mg/m2 | 7 | 1 | Grade 4 neutropenia and thrombocytopenia |
| C | 200 mg BID | 600 mg/m2 | 7 | 0 | - |
*
Intravenously days 1, 8, 15 every 28 days