Anlotinib Hydrochloride Versus Imatinib Mesylate in Locally Advanced, Unresectable or Metastatic Chordoma

NCT04042597 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-08-05

No results posted yet for this study

Summary

For local relapse not amenable to reasonable curative surgery or for those with metastatic chordoma, chemotherapy is recognised as inactive. The major study drug is the small molecular tyrosine kinase inhibitors targeted at the stem cell factor receptor (KIT) and the platelet-derived growth factor receptors (PDGFRA and PDGFRB), eg. imatinib. Anlotinib is a novel tyrosine kinase inhibitor targeting both at VEGFR-2, -3 and PDGFRA and PDGFRB with high affinity, which also showed broad antitumor activity against EGFR and so on. Thus this multicenter, two-armed phase II trial of PKUPH-sarcoma 05 intended to investigate the efficacy and safety of anlotinib versus imatinib on advanced chordoma.

Conditions

Interventions

DRUG

Anlotinib Hydrochloride

anlotinib was given at a fixed dose of 12mg D1-14 every 21 days

Sponsors & Collaborators

  • Peking University Shougang Hospital

    collaborator OTHER
  • Peking University Third Hospital

    collaborator OTHER
  • Peking University First Hospital

    collaborator OTHER
  • Beijing Jishuitan Hospital

    collaborator OTHER
  • Chinese PLA General Hospital

    collaborator OTHER
  • Peking University Cancer Hospital & Institute

    collaborator OTHER
  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    collaborator OTHER
  • Peking University People's Hospital

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-18
Primary Completion
2021-10-30
Completion
2021-12-31

Countries

  • China

Study Locations

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Entities

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 NCT04042597 on ClinicalTrials.gov