Tucidinostat Plus Apatinib for Advanced Osteosarcoma

NCT ID: NCT06125171

Last Updated: 2023-11-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2025-12-31

Brief 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.

Conditions

Osteosarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tucidinostat+Apatinib

Group Type: EXPERIMENTAL

Tucidinostat, Apatinib

Intervention Type: DRUG

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

Interventions

Tucidinostat, Apatinib

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CSIIT-Q54

Identifier Type: -

Identifier Source: org_study_id