Table 3.

Results of primary endpoint

Interim populationOverall population
n = 34N = 86
Group 1Group 2Group 1Group 2
n = 17n = 17an = 40n = 46a
Confirmed ORR n (%; interim analysis stopping rules required >7 events)9 (52.9)10 (58.8)18 (45.0)26 (56.5)
Considered toxic events total number of patients (interim analysis stopping rules required <3 events)73118
 Grade 4 neutropenia2b03b2d
 Febrile neutropenia22c24c,d
 Grade 3 diarrhea4b2c6b4c
 Grade 4 diarrhea0010
  • NOTE: Group 1: UGTA1*1/UGTA1*1; Group 2: UGT1A1*1/UGT1A1*28.

    a1 patient in group 2 was never treated because brain metastases were discovered after the patient's inclusion.

  • b1 patient with grade 4 neutropenia and grade 3 diarrhea.

  • c1 patient with febrile neutropenia and grade 3 diarrhea.

  • d1 patient with grade 4 neutropenia and febrile neutropenia.