Spots Global Cancer Trial Database for A Study of Sulfatinib on Relapsed or Refractory Drug Resistant Osteosarcoma
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Trial Identification
Brief Title: A Study of Sulfatinib on Relapsed or Refractory Drug Resistant Osteosarcoma
Official Title: A Study of Etoposide and Ifosfamide Combined With or Without Sulfatinib on Relapsed or Refractory Drug Resistant Osteosarcoma
Study ID: NCT05590572
Conditions
Study Description
Brief Summary: 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).
Detailed Description: 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.
Eligibility
Minimum Age: 2 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Peking University People's Hospital, Beijing, Beijing, China
Qilu Hospital of Shandong University, Jinan, Shandong, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China
Department of Orthopaedic Surgery, Sixth People's Hospital, Shanghai Jiao Tong University,, Shanghai, Shanghai, China
Department of Orthopedic Surgery Chonnam National University, Donggu, Gwangju, Korea, Republic of
Contact Details
Name: zhaoming Ye, PhD
Affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
Role: STUDY_CHAIR
Name: Binhao Li, PhD
Affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
Role: STUDY_DIRECTOR
Name: zengjie zhang, MD
Affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
Role: PRINCIPAL_INVESTIGATOR
Name: Shengdong Wang, MD
Affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
Role: PRINCIPAL_INVESTIGATOR
Name: Xin Huang, PhD
Affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
Role: PRINCIPAL_INVESTIGATOR
Name: Peng Lin, MD
Affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
Role: PRINCIPAL_INVESTIGATOR
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