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Anlotinib Hydrochloride Versus Imatinib Mesylate in Locally Advanced, Unresectable or Metastatic Chordoma (CSSG-03)

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ClinicalTrials.gov Identifier: NCT04042597
Recruitment Status : Recruiting
First Posted : August 2, 2019
Last Update Posted : August 5, 2019
Sponsor:
Collaborators:
Peking University Shougang Hospital
Peking University Third Hospital
Peking University First Hospital
Beijing Jishuitan Hospital
Chinese PLA General Hospital
Beijing Cancer Hospital
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Information provided by (Responsible Party):
Peking University People's Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Effect of Drugs Quality of Life Chordoma Advanced Cancer Drug: Anlotinib Hydrochloride Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicentre, Open-label, Randomised Phase 2 Trial to Study the Efficacy and Safety of Anlotinib Hydrochloride Versus Imatinib Mesylate in Locally Advanced, Unresectable or Metastatic Chordoma
Actual Study Start Date : July 18, 2019
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A: anlotinib arm
anlotinib was given at a fixed dose of 12mg D1-14 every 21 days
Drug: Anlotinib Hydrochloride
anlotinib was given at a fixed dose of 12mg D1-14 every 21 days

Active Comparator: Arm B: imatinib arm
Imatinib was given at dose of 400 mg twice daily continuously
Drug: Anlotinib Hydrochloride
anlotinib was given at a fixed dose of 12mg D1-14 every 21 days




Primary Outcome Measures :
  1. Objective response rate, ORR [ Time Frame: 6 months ]
    CR+PR in the intent-to-treat population according to RECIST, version 1.1

  2. Progression-free Survival, PFS [ Time Frame: 2 years ]
    Progression-free survival is defined as time from randomisation to the first occurrence of progression of disease or death from any cause within 63 days of last response assessment or randomisation


Secondary Outcome Measures :
  1. Overall Survival, OS [ Time Frame: 5 years ]
    OS is defined as time from randomisation to the first occurrence of death from any cause within 63 days of last response assessment or randomisation.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years and older;
  • histologically proven metastatic or locally advanced chordoma, reviewed by the Pathology Committee of Peking University People's Hospital;
  • not amenable to curative-intent surgery;
  • measurable with computed tomography scan or magnetic resonance imaging, per RECIST, version 1.1.

Exclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG)30 performance status more than 2 ;
  • life expectancy less than 12 weeks;
  • with severe or uncontrolled medical disorders (≥grade 2 of Common Terminology Criteria for Adverse Events version 4.03 [CTCAE version 4.03]) that could jeopardise the outcomes of the study, for example, cardiac clinical symptom or disease with LVEF (left ventricular ejection fraction) <50%, hypertension that could not be well controlled through antihypertensive drugs and so on;
  • weight loss of 20% or more before illness;
  • brain or leptomeningeal metastasis;
  • surgical procedure or radiotherapy within 4 weeks of enrollment;
  • active gastroduodenal ulcer, previous condition associated with risk of bleeding or requiring anticoagulation;
  • proteinuria or hematuria;
  • denutrition with albuminemia less than 25 g/L;
  • pregnant or breastfeeding status;
  • other malignancy, positive HBV/HCV/HIV serology;
  • known allergy to the experimental agents;
  • had ever used anti-angiogenesis TKIs.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04042597


Contacts
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Contact: Lu Xie, M.D. +8613401044719 xie.lu@hotmail.com
Contact: Jie Xu, M.D. +8615901040835 xujie_pkuph@sina.com

Locations
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China, Beijing
Peking University People's Hospital Recruiting
Beijing, Beijing, China, 100044
Contact: Tingting Ren, Ph. D.    +861380095026    tumorcenter@163.com   
Sponsors and Collaborators
Peking University People's Hospital
Peking University Shougang Hospital
Peking University Third Hospital
Peking University First Hospital
Beijing Jishuitan Hospital
Chinese PLA General Hospital
Beijing Cancer Hospital
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Investigators
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Principal Investigator: Wei Guo, M.D. and Ph.D. Musculoskeletal Tumor Center of Peking University People's Hospital

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Responsible Party: Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT04042597     History of Changes
Other Study ID Numbers: PKUPH-sarcoma 05
First Posted: August 2, 2019    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking University People's Hospital:
chordoma
unresectable
anlotinib
imatinib
survival
quality of life
Additional relevant MeSH terms:
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Chordoma
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action