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