Procedures
|
Study Visits
|
---|
C5w2
|
C5w4
|
C6w2
|
C6w4
|
C7w2
|
C7w4
|
Cxw2
|
Cxw4
|
FV
|
---|
Physical examination
|
×
|
×
|
×
|
×
|
×
|
×
|
×
|
×
|
×
|
Lab test for complete blood count
|
×
|
×
|
×
|
×
|
×
|
×
|
×
|
×
|
×
|
Other lab tests(a)
| |
×
| |
×
| |
×
| |
×
|
×
|
Circulating tumor cells
|
×
| |
×
| |
×
| |
×
| | |
Biobank collection
| |
×
| |
×
| |
×
| |
×
|
×
|
Urine analysis(b)
| |
×
| |
×
| |
×
| |
×
|
×
|
PK study(c)
| | | | | | | | | |
Pain score & Quality of life
| |
×
| |
×
| |
×
| |
×
|
×
|
Review of concomitant medications
|
×
|
×
|
×
|
×
|
×
|
×
|
×
|
×
|
×
|
Monitoring for AEs
|
×
|
×
|
×
|
×
|
×
|
×
|
×
|
×
|
×
|
Tumor assessment(d)
| | | | | |
×
| | | |
- Cxwy = cycle x week y; FV = final visit. (a) Lab tests include Na, K, Cl, HCO3, Ca, Mg, P, albumin, AST, ALT, ALP, total bilirubin, direct bilirubin, BUN, Cr, PT, PTT, INR, and LDH; (b) Urine analysis includes a urine pregnancy test for a female patient of childbearing age; (c) Additional samplings for drug monitoring (at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 h) may be required when drug dosage is modified (after ≥7 days of drug administration with an adjusted dose level); (d) Tumor assessment by a CT scan (of the chest ± other organs, if required) or MRI, done at 12-week interval (±1 week); in case of objective tumor response (complete response or partial response), confirmatory imaging studies will be performed at least 4 weeks after initial documentation of response