Dose levels, number of patients enrolled, and dose-limiting toxicities in cycles 1 and 2
Dose level | Schedule | ABT-888 | Topotecan | No. of patients | Dose-limiting toxicities (No. of patients) | ||
---|---|---|---|---|---|---|---|
Dose (po BID) | Days | Dose (mg/m2/d IV) | Days | ||||
1 | A | 10 mg | 1–7 | 1.2 | C1: −8, 2–5 | 6 | Neutropenia (2), thrombocytopenia (1), febrile neutropenia (1) |
C2 onwards: 1–5 | |||||||
−1 | A | 10 mg | 1–7 | 0.9 | C1: −8, 2–5 | 3 | Neutropenia (2) |
C2 onwards: 1–5 | |||||||
−2 | B | 10 mg | C1: 2–5 | 0.75 | 1–5 | 3 | Febrile neutropenia (1), neutropenia (1) |
C2 onwards: 1–5 | |||||||
−3 | B | 10 mg | C1: 2–5 | 0.6 | 1–5 | 4a + 3 | None |
C2 onwards: 1–5 | |||||||
1A | C | 10 mg | 1 | 0.75 | 1–5 | 5 | Thrombocytopenia (2) |
Abbreviation: C, cycle.
aOne patient progressed before completing 2 cycles so was not evaluable for toxicity and was therefore replaced.