Apatinib for Advanced Osteosarcoma After Failure of Standard Multimodal Therapy

• Status: Completed
• Trial end date: 2018-01-08
• Target enrollment: 0
• Participant gender: All

Summary

After standard multimodal therapy, the prognosis of relapsed and unresectable high-grade osteosarcoma is dismal and unchanged over the last decades.Thus, the investigators explored apatinib activity in patients with relapsed and unresectable osteosarcoma after the failure of first-line or second-line chemotherapy. Patients >16 years, progressing after standard treatment, were eligible to receive 500 mg or 750 mg of apatinib once daily until progression or unacceptable toxicity. The primary end point was progression-free survival (PFS) at 4 months and objective response rate (ORR). Secondary objectives were PFS, overall survival (OS), clinical benefit rate (CBR), defined as no progression at 6 months and safety.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GUO WEI
• Treatments: Apatinib

Criteria

Inclusion Criteria:

• age >16 years;

• diagnosis confirmed histologically and reviewed centrally;

• prior treatment (completed >4 weeks before trial entry) consisted of standard high-grade osteosarcoma chemotherapy agents including doxorubicin, cisplatin, high- dose methotrexate, and ifosfamide; metastatic relapsed and unresectable progressive disease (PD);

• Eastern Cooperative Oncology Group performance status 0-1 with a life expectancy >3 months;

• adequate renal, hepatic, and hemopoietic function;

• normal or controlled blood pressure;

• surgery and/or radiotherapy completion at least 1 month before enrollment.

Exclusion Criteria:

• no pulmonary artery or venous tumor embolus;

• previously exposed to other TKIs;

• central nervous system metastasis;

• have had other kinds of malignant tumors at the same time;

• cardiac insufficiency or arrhythmia;

• uncontrolled complications, such as diabetes mellitus and so on;

• coagulation disorders;

• urine protein≥ ++;

• pleural or peritoneal effusion that needs to be handled by surgical treatment;

• combined with other infections or wounds.