Tucidinostat Plus Apatinib for Advanced Osteosarcoma

Osteosarcoma Clinical Trial

Official title:

A Phase II Clinical Trial of Tucidinostat in Combination With Apatinib in Patients With Relapsed or Refractory Osteosarcoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06125171
• Other study ID #: CSIIT-Q54
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 2024
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: Wuhan Union Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteosarcoma

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-month progression-free survival rate	The proportion of patients who did not experience disease progression or die from disease progression within 6 months from the treatment	6 months
Secondary	Progression-free survival(PFS)	Time from treatment until disease progression or death	2 years
Secondary	Objective Response Rate(ORR)	Objective Response Rate(ORR)by RECIST 1.1,the total proportion of patients with complete response(CR), partial response(PR)	2 years
Secondary	Disease Control Rate (DCR)	the total proportion of patients with complete response(CR), partial response(PR)and stable disease(SD)	2 years
Secondary	Overall survival(OS)	Time from treatment until death from any cause	2 years