Table 2.

Adverse events ≥ possibly related to GRN1005

Dose, mg/m230 (n = 1)60 (n = 3)120 (n = 3)200 (n = 3)300 (n = 7)a420 (n = 6)a500 (n = 4)a550 (n = 3)650b (n = 20)700 (n = 6)
NCI-CTCAE grade1–23–41–23–41–23–41–23–41–23–41–23–41–23–41–23–41–23–41–23–4
Hematologic
 Neutropenia001000201122101111804
 Febrile neutropenia00000000000000001 (DLT)1 (DLT)00
 Anemia103010306160403016341
 Thrombocytopenia00100000111110108312 (1 DLT)
Nonhematologic
 Fatigue10000010103010105210
 Alopecia00000000102010107000
 Neuropathy00000000001000107 (1 DLT)111
 Dehydration000000000100000032 (1 DLT)d00
 Hypotension00000000011010001001 (DLT)
 Infusion reactionc00000010001100001100
 Mucositis00000000010000006011
 Rash00000000000000005000
 Pneumonia000000000000000001 (DLT)00
Gastrointestinal
 Nausea/vomiting00101010201010206001
 Diarrhea00000000102000206010
 Anorexia10000010100000102110
  • aBecause of discovery of cloudy infusion solutions, dosing was repeated in additional patients at the 300 to 500 mg/m2 dose levels and escalated again from that point.

  • bA total of 650 mg/m2 administered once every 3 weeks was determined to be the MTD.

  • cInfusion reactions were sometimes characterized by facial flushing, bradycardia, hypotension, dizziness, shortness of breath, chest tightening, and rash.

  • dThis patient experienced grade III dehydration and grade III stomatitis during cycle 1 of treatment.