A phase IA dose-escalation study of PHI-101, a new checkpoint kinase 2 inhibitor, for platinum-resistant recurrent ovarian cancer

Table 1 Definition of dose limiting toxicity (DLT)

CTCAE Term	CTCAE version 5.0
Hematological toxicity
Febrile neutropenia	grade ≥ 3
Neutrophil count decreased	grade ≥ 3 for > 7 days
WBC decreased	grade ≥ 3
Platelet count decreased	grade ≥ 3
Platelet count decreased	grade < 3 requiring blood transfusion
Anemia	grade ≥ 3
Non-hematological toxicity
ECG QT corrected interval prolonged	grade ≥ 3
Nausea	grade ≥ 3 for > 7 days despite the adequate and optimal therapy
Tumor pain	grade ≥ 3 for > 7 days despite the adequate and optimal therapy
Vomiting	grade 3 for > 7 days despite the adequate and optimal therapy, or grade ≥ 4
Diarrhea or associated electrolyte abnormalities	grade ≥ 3 for > 2 days despite the adequate and optimal therapy
Fatigue	grade ≥ 3 for > 7 days
Anorexia	grade ≥ 3 for > 7 days
Hypophosphatemia, hypomagnesemia, or hypocalcemia	grade ≥ 3 for > 2 days despite the adequate and optimal therapy
Asymptomatic AST, ALT, ALP, or GGT	grade ≥ 3 for > 7 days
Baseline AST or ALT ≥ 2.5 to 5 X ULN in patients with confirmed liver metastases	AST or ALT > 8 X ULN for > 7 days
Baseline ALP ≥ 2 to 5 X ULN in patients with confirmed liver metastases	ALP > 8 X ULN for > 7 days
All the other ADRs excluding above	grade ≥ 3
Other toxicity
ADR with dose interruption (temporary discontinuation) of PHI-101 for > 4 weeks

Abbreviations: ALP, alkaline phosphatase; ALT, alanine transferase; AST, aspartate transferase; CTCAE, Common Terminology Criteria for Adverse Events; ECG, electrocardiography; GGT, γ-glutamyl transferase; ULN, upper normal limit; WBC, white blood count.

ISSN: 1471-2407