Phase II, Multi-Center, Open-Label, Single-Arm Study Evaluating the Efficacy and Safety of Mycophenolate Mofetil in Patients with High-Grade Locally Advanced or Metastatic Osteosarcoma (ESMMO)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20190701001

Enrollment

Registered

2019-07-01

Start date

2019-08-05

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-grade locally advanced or metastatic osteosarcoma Osteosarcoma

Interventions

Mycophenolate mofetil is normally used for the prophylaxis of organ rejection following transplantation.

Experimental Drug

Mycophenolate mofetil

Eligibility

Sex/Gender

All

Age

13 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. High-grade locally advanced or metastatic osteosarcoma; 2. Measurable disease; 3. Evidence of disease progression after treatment with standard chemotherapy regimen or evidence of patient refusal for any further treatment with standard chemotherapy regimens; 4. ECOG performance status of <=2; 5. Age >=13 years; 6. Adequate organ function; and 7. Evidence of a personally signed and dated informed consent (or assent, when applicable) document.

Exclusion criteria

Exclusion criteria: 1. History of another malignancy within 5 years; 2. Current treatment with another investigational agent and/or systemic anticancer therapy; 3. Surgery and/or radiotherapy for curative intent; 4. History of allergic reactions attributed to mycophenolate mofetil, mycophenolic acid, or any ingredients of the drugs; 5. History of severe or uncontrolled medical conditions or laboratory abnormality; 6. Impaired renal function; 7. Known or suspected pregnancy or breastfeeding; 8. Any other conditions in which mycophenolate mofetil is contradicted; 9. Unable to swallow oral medications; 10. Major surgery; or 11. Significantly altered mental status.

Design outcomes

Primary

Measure	Time frame
Progression-free survival at 16 weeks CT/MRI	—

Secondary

Measure	Time frame
Progression-free survival n/a CT/MRI,Overall survival n/a n/a,Overall response rate n/a CT/MRI,Safety parameters n/a n/a,Pharmacokinetic parameters n/a Blood sampling,Biomarkers n/a Blood sampling,Pain score n/a Questionnaire,Quality of life n/a Questionnaire	—

Countries

Thailand

Contacts

Public ContactDumnoensun Pruksakorn

Faculty of Medicine, Chiang Mai University

dumnoensun.p@cmu.ac.th053935544

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026