Chiauranib , which simultaneously targets against VEGFR/Aurora B/CSF-1R, several key kinases involved in tumor angiogenesis, tumor cell mitosis, and chronic inflammatory microenvironment.
Chiauranib is a novel orally active multi-target inhibitor that simultaneously inhibits the angiogenesis-related kinases (VEGFR2, VEGFR1, VEGFR3, PDGFRa and c-Kit), mitosis-related kinase Aurora B and chronic inflammationrelated kinase CSF-1R in a high potency manner with the IC50 at a single-digit nanomolar range. In particular, Chiauranib showed very high selectivity in the kinase inhibition profile with little activity on off-target non-receptor kinases, proteins, GPCR and ion channels, indicative of a better drug safety profile in terms of clinical relevance. Because of its broad preclinical anti-tumor efficacy and the potential to improve conventional TKI kinase inhibitor therapy in various cancer indications,Chiauranib has now entered phase Ib clinical trials. This clinical trial is studying the efficacy and safety of chiauranib works in treating patients with relapsed or refractory small cell lung cancer, in the meantime, exploreing the latent biomarkers accompany with chiauranib, as well as the relevancy of which and clinical benefit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
CS2164
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Objective reponse rate(ORR)
ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: Up to a minimum 24 weeks after the last participant's first dose, or progression, or 75% subjects died.
Number of subjects with Adverse Events as a Measure of Safety and Tolerability
Safety evaluation as measured by adverse events (AE), vital signs,electrocardiograph(ECG) and abnormal laboratory results according to CTCAE V4.03
Time frame: Up to a minimum 28 weeks after the last participant's first dose, or progression, or 75% subjects died.
Disease-control rate (DCR)
Time frame: Up to a minimum 24 weeks after the last participant's first dose, or progression, or 75% subjects died.
Time to progression(TTP)
Time frame: From date of the first dose of study drug until the date of first documented progression NOT including death, assessed up to 24 months
Duration of response (DOR)
Time frame: from the date of first documented objective response until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Progression-free survival (PFS)
Time frame: From date of the first dose of study drug until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Overall survival (OS)
Time frame: From date of the first dose of study drug until the date of death from any cause, assessed up to 24 months
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