Table 1.

Dose cohorts and adverse events of at least grade 2, at least possibly related to study medication

DLVeliparib (QD)Cyclophosphamide (QD × 21 days)Total no. of patientsAdverse eventGradeaNo. of patients
120 mg × 7 days50 mg3Lymphopenia21
31
230 mg × 7 days50 mg3Lymphopenia22
Leucopenia21
Neutropenia22
Thrombocytopenia21
330 mg × 14 days50 mg3Lymphopenia22
Leucopenia21
Anemia21
440 mg × 21 days50 mg3Lymphopenia21
31
Leucopenia21
Neutropenia21
Allergic reaction21
540 mg × 21 days100 mg3Lymphopenia21
32
Fatigue31
650 mg × 21 days50 mg3Lymphopenia32
Leucopenia21
760 mg × 21 days50 mg14Lymphopenia22
33
43
Leucopenia24
Neutropenia22
Anemia24
Thrombocytopenia22
Fatigue22
Hypophosphatemia31
Hypoalbuminemia21
Nausea21
Vomiting21
Upper respiratory infection21
Urinary tract infection21
Urinary tract obstruction31
880 mg × 21 days50 mg3Lymphopenia21
Leucopenia21
Neutropenia21
Acute respiratory failure41b
Abdominal distension, abdominal pain31b
  • Abbreviation: QD, once a day.

  • aWorst grade reported per patient.

  • bDLT. The patient with acute respiratory failure died; the treating physician felt the cause of death was likely disease progression, but the possibility that the study drug combination may have contributed to the respiratory failure could not be excluded.