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NOT YET RECRUITING
NCT05590572
PHASE1/PHASE2

A Study of Sulfatinib on Relapsed or Refractory Drug Resistant Osteosarcoma

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

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).

Official title: A Study of Etoposide and Ifosfamide Combined With or Without Sulfatinib on Relapsed or Refractory Drug Resistant Osteosarcoma

Key Details

Gender

All

Age Range

2 Years - 25 Years

Study Type

INTERVENTIONAL

Enrollment

148

Start Date

2023-01

Completion Date

2027-12

Last Updated

2022-10-21

Healthy Volunteers

No

Conditions

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.

Locations (5)

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

Department of Orthopedic Surgery Chonnam National University

Donggu, Gwangju, South Korea