Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04830813
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2021-03-29
Brief Title:
Phase 3 Clinical Study of Chiauranib Capsule in Patients With Small-cell Lung Cancer
Sponsor:
Chipscreen Biosciences Ltd
Organization:
Chipscreen Biosciences Ltd
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Multicenter Phase 3 Clinical Study of Chiauranib Capsule in Patients With Progressed or Relapsed Small-cell Lung Cancer After 2 Lines Chemotherapy CHIS
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Chiauranib which simultaneously targets against VEGFRAurora BCSF-1R several key kinases involved in tumor angiogenesis tumor cell mitosis and chronic inflammatory microenvironment
Detailed Description:
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 IbII 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
In July 2017 the sponsor initiated a phase IbII 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None