Table 3. Ongoing trials of apatinib for sarcoma.
Clinical trial identifier | NCT03121846 | NCT03064243 | NCT03104335 | NCT02711007 | NCT03163381 |
---|---|---|---|---|---|
Country | China | China | China | China | China |
Sponsor | Tianjin Medical University Cancer Institute and Hospital | Shanghai Jiao Tong University Affiliated Sixth People's Hospital | Peking University People's Hospital | Peking University People's Hospital | Henan Cancer Hospital |
Phase | II | II | II | II/III | II |
Sarcomas type | Stage IV STS patients after failure of traditional chemotherapy | Advanced STS | Advanced STS Patients after failure of traditional therapy | Relapsed and unresectable high-grade osteosarcoma after failure of standard multimodal therapy | Advanced osteosarcoma and STS |
Intervention Model | Single arm | Single arm | Single arm | Single arm | Single arm |
Masking | None | None | None | None | None |
Research center | Multicenter | Single center | Multicenter | Single center | Multicenter |
Estimated enrollment | 80 | 53 | 37 | 37 | 40 |
Primary endpoint | PFS | Six months PFS rate | ORR | PFS, CBR | PFS |
Secondary endpoint | DCR, ORR, OS, AEs | - | PFS, OS | OS, ORR, DOR | OS |
Start date | May 1, 2017 | March 1, 2017 | April 1, 2017 | March 2016 | April 11, 2017 |
Status | Recruiting | Not yet recruiting | Recruiting | Recruiting | Recruiting |
Abbreviations: STS, soft-tissue sarcoma; PFS, progression-free survival; ORR, objective response rate; CBR, clinical benefit rate; DCR, disease control rate; OS, overall survival; AEs, adverse effects; DOR, duration of response.