Tucidinostat Plus Apatinib for Advanced Osteosarcoma

NCT06125171 | Unknown Phase 2

• 1 other identifier: CSIIT-Q54
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Progression-free survival(PFS)

  2 years

• Objective Response Rate（ORR）

  2 years

• Disease Control Rate （DCR）

  2 years

• Overall survival(OS)

  2 years

Study Arms (1)

Tucidinostat+Apatinib

EXPERIMENTAL

Drug: Tucidinostat, Apatinib

Interventions

Tucidinostat, Apatinib 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

Tucidinostat+Apatinib

Eligibility Criteria

• Age: 10 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥10 years, ≤ 75 years;
• Histologically confirmed Advanced classic osteosarcoma with unresectable recurrence or metastatic disease ；
• Prior treatment consisted of standard chemotherapy agents including doxorubicin, cisplatin, methotrexate, and ifosfamide;
• Eastern Collaborative Oncology Group (ECOG) 0\~2；
• Tumor size is measurable according to RECIST1.1 criteria；
• Adequate organ function；
• Life expectancy is more than 3 months；
• Willing and able to provide written informed consent.

You may not qualify if:

• Previously exposed to histone deacetylase inhibitors or angiogenesis inhibitors;
• Urine protein≥ ++;
• FBG\>10mmol/L;
• Uncontrolled blodd pressure (ystolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 90 mmHg);
• Known active CNS metastases and/or carcinomatous meningitis;
• Not able to take medicine orally;
• Coagulant function abnormality (PT\>16s, APTT\> 43s, TT\>21s, FIB）\<2g/L);
• 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;
• Major surgery received or severe traumatic injury, fracture, or ulcer occurred within 4 weeks of the first dose of study medication.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Osteosarcoma

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; apatinib

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2023
• First Posted: November 9, 2023
• Study Start: January 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share