Tucidinostat Plus Apatinib for Advanced Osteosarcoma

Sponsor

Wuhan Union Hospital, China (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06125171

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteosarcoma	Drug: Tucidinostat, Apatinib	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

46 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tucidinostat+Apatinib	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

Arm

Intervention/Treatment

Experimental: Tucidinostat+Apatinib

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Wuhan Union Hospital, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wuhan Union Hospital, China

ClinicalTrials.gov Identifier:

NCT06125171

Other Study ID Numbers:

CSIIT-Q54

First Posted:

Nov 9, 2023

Last Update Posted:

Nov 9, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Osteosarcoma

Apatinib

Study Results

No Results Posted as of Nov 9, 2023