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. In July 2017, the sponsor initiated a phase Ib/II trial (CAR105). As of October 9, 2020, a total of 42 subjects entered the safety analysis and 41 subjects entered the efficacy analysis. The results of the phased trial analysis show the preliminary efficacy of this product in the treatment of SCLC at ≥3 lines. 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
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
184
Patients take Chiauranib capsules 50mg, orally once daily, 21 days as a cycle until objective disease progression.
Participants received Chiauranib placebo capsule matching Chiauranib orally once daily until objective disease progression.
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
PFS
Progression-free survival
Time frame: From date of the first dose of study drug until the date of first documented progression or relapse or date of death from any cause, whichever came first, assessed up to 24 months
OS
Overall survival
Time frame: From date of the first dose of study drug until the date of death from any cause, assessed up to 24 months
ORR
Objective reponse rate
Time frame: Up to a minimum 24 weeks after the last participant's first dose, or progression, or 75% subjects died
DOR
Duration of response
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
DCR
Disease-control rate
Time frame: Up to a minimum 24 weeks after the last participant's first dose, or progression, or 75% subjects died
percentage of AEs
Safety
Time frame: 28 days after the last participant 's last medication or new anti-tumor therapy
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.