Tucidinostat Plus Apatinib for Advanced Osteosarcoma

Phase 2

Not yet recruiting

• Conditions: Osteosarcoma
• Interventions: Drug: Tucidinostat, Apatinib

• Registration Number: NCT06125171
• Lead Sponsor: Wuhan Union Hospital, China

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-05
• Study First Submitted QC: 2023-11-05
• Last Update Submitted: 2023-11-05
• Study First Posted: 2023-11-09
• Last Update Posted: 2023-11-09
• Study Start: 2024-01
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tucidinostat+Apatinib	Tucidinostat, Apatinib	-

Primary Outcome Measures

Name	Time	Method
6-month progression-free survival rate	6 months	The proportion of patients who did not experience disease progression or die from disease progression within 6 months from the treatment

Secondary Outcome Measures

Name	Time	Method
Progression-free survival(PFS)	2 years	Time from treatment until disease progression or death
Objective Response Rate（ORR）	2 years	Objective Response Rate（ORR）by RECIST 1.1,the total proportion of patients with complete response（CR）, partial response（PR）
Disease Control Rate （DCR）	2 years	the total proportion of patients with complete response（CR）, partial response（PR）and stable disease（SD）
Overall survival(OS)	2 years	Time from treatment until death from any cause