A Phase 2 interventional study of Anlotinib Hydrochloride in Effect of Drugs, Quality of Life and Chordoma, sponsored by Peking University People's Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-05.
Sponsored by Peking University People's Hospital · Phase 2, Interventional, and Treatment
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.
63 studies on the registry are indexed under Chordoma; 16 are open to participants now.
This study's planned enrollment of 60 is above the median of 38 across 47 interventional studies indexed under Chordoma.
Browse Chordoma studies →Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
anlotinib was given at a fixed dose of 12mg D1-14 every 21 days
Drug: Anlotinib Hydrochloride
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
Objective response rate, ORR
CR+PR in the intent-to-treat population according to RECIST, version 1.1
Time frame: 6 months
Progression-free Survival, PFS
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
Time frame: 2 years
Overall Survival, OS
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.
Time frame: 5 years
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Peking University People's Hospital