A Study of Sulfatinib on Relapsed or Refractory Drug Resistant Osteosarcoma

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT05590572
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Osteosarcoma

Eligibility Criteria

Sex
ALL
Age
2 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Sulfatinib — DRUG
    (1) Sulfatinib: 300 mg, oral once a day (QD), 21 days as a cycle
  • Etoposide — DRUG
    (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.;
  • Isophosphamide — DRUG
    (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.

Study Details

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).

Key Dates

First listed
Oct 21, 2022
Start date
Jan 31, 2023
Status verified
Oct 2022
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
148 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Etoposide plus Ifosfamide group
    Children and adolescents with relapsed or refractory drug resistant osteosarcoma
  • Experimental: Etoposide plus Ifosfamide Combined With Sulfatinib
    Children and adolescents with relapsed or refractory drug resistant osteosarcoma

Primary Outcome Measure

4 months progression-free survival [ Time Frame: 4 months ]

Central Contacts

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