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)
- Conditions
- High-grade locally advanced or metastatic osteosarcomaOsteosarcoma
- Registration Number
- TCTR20190701001
- Lead Sponsor
- Faculty of Medicine, Chiang Mai University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 27
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival at 16 weeks CT/MRI
- Secondary Outcome Measures
Name Time Method 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