Apatinib for Advanced Osteosarcoma After Failure of Standard Multimodal Therapy

Sponsor
GUO WEI
Study ID
NCT02711007
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • Metastasis
  • Osteosarcoma

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • apatinib — DRUG
    Apatinib is a small-molecule VEGFR tyrosine kinase inhibitor, similar to vatalanib (PTK787), but with a binding affinity 10 times that of vatalanib or sorafenib.

Study Details

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.

Key Dates

Start date
Mar 31, 2016
Status verified
Apr 2018
Primary completion
Dec 30, 2017
Completion
Jan 8, 2018

Study Design

Enrollment
37 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: apatinib
    apatinib 750mg tablet or 500mg tablet by mouth, Qd half an hour after dinner

Primary Outcome Measure

Progression-free survival, PFS [ Time Frame: 4 months ]

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