Table 3 Schedule of assessments for Arm 2 patients
Time-point → Assessments ↓ | Each treatment cycle | End of treatment visit | Follow-up | |||
|---|---|---|---|---|---|---|
Day 1 | Day 2 (cycles 1 and 2 only) | Day 8 | Day 15 | 30 days post last treatment (± 5 days) | Every 3 months (± 5 days) | |
Vital signs | X | X | X | X | ||
ECOG Performance Status | X | X | X | X | ||
Physical examination | X | X | X | X | ||
12-lead ECG | X | X | ||||
Haematology | X | X | X | X | ||
Biochemistry | X | X | X | X | ||
Coagulation | X | X | ||||
Fasting serum glucose | X | X | ||||
Glycosylated haemoglobin (HbA1c) | X | |||||
Fasting lipid profile | X | X | ||||
Urinalysis | X | X Cycles 1 and 2 only | X | |||
Pregnancy test | X | X | ||||
Research blood sample for ctDNA | X | X | ||||
Radiological imaging assessment (CT with contrast/MRI chest, abdomen and pelvis) | Every 2 cycles/8 weeks (± 7 days) | X | X | |||
CA125 | X | X | X | |||
In-home daily fasting glucose monitoring | X | X | X | X | ||
Paclitaxel administration | X | X | X | |||
TAK228 administration/compliance: administration at days 2–4, 9–11, 16–18 and 23–25 per cycle | X | X | X | X | ||
Quality of Life Questionnaires (EORTC QLQ-C30 and EORTC QLQ-OV28) | X | X | ||||
Adverse events (NCI CTCAE version 4.03) | X | X | X | X | X | X |
Concomitant medications | X | X | X | X | X | |
Record of further treatment | X | |||||
Record of overall survival | X | |||||