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 3 Scheduled visits and assessments

Procedures	Study Visits
Procedures	SV	C₁w₀	C₁w₁	C₁w₂	C₁w₄	C₂w₂	C₂w₄	C₃w₂	C₃w₄	C₄w₂	C₄w₄	FV
Informed consent obtained	×
Inclusion/exclusion criteria assessments	×
History taking	×
Physical examination	×	×	×	×	×	×	×	×	×	×	×	×
ECOG status	×
Electrocardiogram	×
Lab test for complete blood count	×			×	×	×	×	×	×	×	×	×
Lab test for fasting blood glucose	×
Other lab tests^(a)	×			×	×		×		×		×	×
Circulating tumor cells		×^(b)	×^(b)	×		×		×		×
Biobank collection	×				×		×		×		×	×
Urine analysis^(c)	×			×	×		×		×		×	×
Stool examination	×											×
Pharmacokinetic study^{(d), (e)}		×	×
Pain score & Quality of life		×			×		×		×		×	×
Review of concomitant medications	×	×	×	×	×	×	×	×	×	×	×	×
Monitoring for adverse events			×	×	×	×	×	×	×	×	×	×
Tumor assessment^(f)	×						×				×

SV = screening visit; 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) Blood obtained from the pharmacokinetic study will be used for measurement of circulating tumor cells on C₁W₀ and C₁W₁ so that no additional blood samples will be collected; ^(c) Urine analysis includes a urine pregnancy test for a female patient of childbearing age; ^(d) Blood samplings (at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 h); ^(e) Additional samplings for drug monitoring may be required when drug dosage is modified (after ≥7 days of drug administration with an adjusted dose level); ^(f) Tumor assessment by a computerized tomography (CT) scan (of the chest ± other organs, if required) or magnetic resonance imaging (MRI), done at baseline, 8 ± 1 weeks and 16 ± 1 weeks after initiation of study drug administration; 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

ISSN: 1471-2407