A Study of Sulfatinib on Relapsed or Refractory Drug Resistant Osteosarcoma

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).

Conditions

• Osteosarcoma

Interventions

DRUG

Sulfatinib

(1) Sulfatinib: 300 mg, oral once a day (QD), 21 days as a cycle

DRUG

Etoposide

(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.;

DRUG

Isophosphamide

(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.

Sponsors & Collaborators

• Chonnam National University

  collaborator OTHER

• Peking University People's Hospital

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• Ruijin Hospital

  collaborator OTHER

• Shanghai Jiao Tong University Affiliated Sixth People's Hospital

  collaborator OTHER

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  lead OTHER

Principal Investigators

• zhaoming Ye, PhD · Second Affiliated Hospital, School of Medicine, Zhejiang University

• Binhao Li, PhD · Second Affiliated Hospital, School of Medicine, Zhejiang University

• zengjie zhang, MD · Second Affiliated Hospital, School of Medicine, Zhejiang University

• Shengdong Wang, MD · Second Affiliated Hospital, School of Medicine, Zhejiang University

• Xin Huang, PhD · Second Affiliated Hospital, School of Medicine, Zhejiang University

• Peng Lin, MD · Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

25 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-31

Primary Completion

2026-12-31

Completion

2027-12-31

Countries

• China
• South Korea

Study Locations