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Trial Title:
Tucidinostat Plus Apatinib for Advanced Osteosarcoma
NCT ID:
NCT06125171
Condition:
Osteosarcoma
Conditions: Official terms:
Osteosarcoma
Apatinib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tucidinostat, Apatinib
Description:
Tucidinostat:
age≥18years, 30mg, po., biw, q4w; age≥10years，<18years，0.5mg/kg, biw, q4w
Apatinib:
BSA≥1.2m^2, 500mg, qd, q4w BSA<1.2m^2, 250mg, qd, q4w
Arm group label:
Tucidinostat+Apatinib
Summary:
This phase II study was designed to assess the efficacy and safety of the combination of
Apatinib, Tucidinostat (chidamide), a histone deacetylase inhibitor in relapsed or
refractory osteosarcoma patients.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥10 years, ≤ 75 years;
2. Histologically confirmed Advanced classic osteosarcoma with unresectable recurrence
or metastatic disease ；
3. Prior treatment consisted of standard chemotherapy agents including doxorubicin,
cisplatin, methotrexate, and ifosfamide;
4. Eastern Collaborative Oncology Group (ECOG) 0~2；
5. Tumor size is measurable according to RECIST1.1 criteria；
6. Adequate organ function；
7. Life expectancy is more than 3 months；
8. Willing and able to provide written informed consent.
Exclusion Criteria:
1. Previously exposed to histone deacetylase inhibitors or angiogenesis inhibitors;
2. Urine protein≥ ++;
3. FBG>10mmol/L;
4. Uncontrolled blodd pressure (ystolic blood pressure > 150 mmHg and/or diastolic
blood pressure > 90 mmHg);
5. Known active CNS metastases and/or carcinomatous meningitis;
6. Not able to take medicine orally;
7. Coagulant function abnormality (PT>16s, APTT> 43s, TT>21s, FIB）<2g/L);
8. Uncontrolled clinically significant systemic diseases, including active infection,
unstable angina, angina occurred within 3 months,≥ NYHA II congestive heart failure,
myocardial infarction occurred within 6 months, severe arrhythmia, liver, kidney, or
metabolic disease;
9. Major surgery received or severe traumatic injury, fracture, or ulcer occurred
within 4 weeks of the first dose of study medication.
Gender:
All
Minimum age:
10 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
January 2024
Completion date:
December 2025
Lead sponsor:
Agency:
Wuhan Union Hospital, China
Agency class:
Other
Source:
Wuhan Union Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06125171
