This is a phase 1/2 study evaluating safety, tolerability, and efficacy of Sulfatinib in combination with chemotherapy (ifosfamide and etoposide) in children and adolescents with refractory or relapsed osteosarcoma ( combination Sulfatinib).
The study consists of 2 cohorts: Cohort 1 (Traditional chemotherapy) will evaluate the efficacy of ifosfamide and etoposide in children, adolescents, and young adults with relapsed or refractory osteosarcoma. Cohort 2 (Combination Expansion) will evaluate the efficacy of Sulfatinib in combination with ifosfamide and etoposide in children, adolescents, and young adults with relapsed or refractory osteosarcoma. Sulfatinib will be provided as hard capsules containing 300 mg Sulfatinib. Sulfatinib capsules should be dissolved in water or apple juice for those who are unable to swallow capsules.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
148
(1) Sulfatinib: 300 mg, oral once a day (QD), 21 days as a cycle
(1) Etoposide: 100 mg/m2/day (initial dose) will be administered on the first to third days of each 21 day cycle, a total of 5 cycles. The dose of etoposide can be reduced to 80 mg/m2/day and 60 mg/m2/day.;
(1) Isophosphamide: 3000 mg/m2/day (initial dose) will be administered on the first to third days of each 21 day cycle for 5 cycles. The dose of ifosfamide can be reduced to 2400 mg/m2/day and 1800 mg/m2/day.
Peking University People's Hospital
Beijing, Beijing Municipality, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Department of Orthopaedic Surgery, Sixth People's Hospital, Shanghai Jiao Tong University,
Shanghai, Shanghai Municipality, China
4 months progression-free survival
The proportion of patients who had no objective tumor progression or death from the start of treatment to 4 months of follow-up.
Time frame: 4 months
Efficacy evaluation in solid tumors
Complete response (CR), all target and non-target lesions (non-lymph nodes) disappear, and the diameter of all pathologic lymph nodes (both target and non-target) must be reduced to \<10 mm; Partial response (PR), using baseline total diameter as reference, reduced the total diameter of target lesions by at least 30%.
Time frame: 2 months
Best of response,BOR
From the date of the first administration of the study drug to disease progression or death, whichever occurs first.
Time frame: 4 months
Duration of Remission (DOR)
Complete response (CR)/ partial response (PR) was first recorded until disease progression was first recorded until the data cutoff date.
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Department of Orthopedic Surgery Chonnam National University
Donggu, Gwangju, South Korea