CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 37 enrolled
Drug / intervention
apatinibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02711007
NCT02711007Phase 3Completed

A Phase II Trial of Apatinib in Relapsed and Unresectable High-grade Osteosarcoma After Failure of Standard Multimodal Therapy

GUO WEI·interventional·Posted Mar 17, 2016·Updated Apr 23, 2018

In Brief

A Phase 3 clinical trial evaluating apatinib for Osteosarcoma and Metastasis. Completed, enrolled 37 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 17, 2016
Enrollment StartMar 1, 2016
Primary CompletionDec 30, 2017
Study CompletionJan 8, 2018
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 10.3 years ago

Interventions

apatinibdrug

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.