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Famitinib Plus Camrelizumab & Famitinib Alone & Famitinib Plus Ifosfamide in Advanced Osteosarcoma

NCT04044378 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2020-05-19

No results posted yet for this study

Summary

Results of previous study showed high objective response but short-term activity of anti-angiogenesis tyrosine kinase inhibitors in advanced osteosarcoma. Given the recent success of immunotherapies, combinations of antiangiogenics with immune checkpoint blockers have become an attractive strategy. The investigators had completed an prospective phase 2 trial of the combination of apatinib and camrelizumab on advanced osteosarcoma and showed prolonged progression-free survival for this combination. Famitinib is a novel tyrosine kinase inhibitor targeting VEGFR-2, -3 and FGFR-1, -2, -3, -4 with high affinity, which showed broad antitumor activity against a variety of xenograft models.

A Study to Compare the Efficacy and Safety of Levatinib with or without Ifosfamide and Etoposide in Children, Adolescents and Young Adults With Relapsed and Refractory Osteosarcoma showed promising median PFS of 11.3 months. Thus we also try to investigate the combination efficacy of TKIs with chemotherapy in advanced osteosarcoma.

This study aims to investigate the recommended phase 2 dose for pediatric use of famitinib in combination with camrelizumab and trys to explore the efficacy and safety for single drug famitinib, famitinib and camrelizumab and famitinib and ifosfamide in patients with inoperable high-grade osteosarcoma progressing after chemotherapy.

Conditions

  • Effect of Drugs
  • Progression
  • Pediatric Cancer

Interventions

DRUG

Famitinib

famitinib with RP2D orally daily

DRUG

Ifosfamide

ifosfamide 1.8g/m2/d d1-3, 15-17 Q4W infusion

DRUG

Camrelizumab

camrelizumab 200mg infusion once Q2W

Sponsors & Collaborators

  • Peking University Shougang Hospital

    collaborator OTHER

  • Jiangsu HengRui Medicine Co., Ltd.

    collaborator INDUSTRY

  • Peking University People's Hospital

    lead OTHER

Principal Investigators

  • Wei Guo, Ph.D. and M.D. · Musculoskeletal Tumor Center of Peking University Shougang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-15
Primary Completion
2021-09-30
Completion
2022-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04044378 on ClinicalTrials.gov