Table 1.

Dose levels, number of patients enrolled, and dose-limiting toxicities in cycles 1 and 2

Dose levelScheduleABT-888TopotecanNo. of patientsDose-limiting toxicities (No. of patients)
Dose (po BID)DaysDose (mg/m2/d IV)Days
1A10 mg1–71.2C1: −8, 2–56Neutropenia (2), thrombocytopenia (1), febrile neutropenia (1)
C2 onwards: 1–5
−1A10 mg1–70.9C1: −8, 2–53Neutropenia (2)
C2 onwards: 1–5
−2B10 mgC1: 2–50.751–53Febrile neutropenia (1), neutropenia (1)
C2 onwards: 1–5
−3B10 mgC1: 2–50.61–54a + 3None
C2 onwards: 1–5
1AC10 mg10.751–55Thrombocytopenia (2)

Abbreviation: C, cycle.

  • aOne patient progressed before completing 2 cycles so was not evaluable for toxicity and was therefore replaced.