Phase II, multi-center, open-label, single-arm clinical trial evaluating the efficacy and safety of Mycophenolate Mofetil in patients with high-grade locally advanced or metastatic osteosarcoma (ESMMO): rationale and design of the ESMMO trial

Table 4 Additional visits and assessments in the extension period

Procedures	Study Visits
Procedures	C₅w₂	C₅w₄	C₆w₂	C₆w₄	C₇w₂	C₇w₄	C_xw₂	C_xw₄	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)						×

C_xw_y = 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

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