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COMPLETEDPHASE1

Phase Ib/II Study of Chiauranib in Patients With Small Cell Lung Cancer

Efficacy and Safety of Chiauranib in Relapsed/Refractory Small Cell Lung Cancer: a Single-arm, Open-label, Multi-center, Exploratory Phase Ib Study

NCT03216343•Chipscreen Biosciences, Ltd.

View on ClinicalTrials.gov

Summary

Chiauranib , which simultaneously targets against VEGFR/Aurora B/CSF-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. 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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female, age ≥ 18 years and ≤75 years;
•2. Cytologically or histologically confirmed small cell lung cancer;
•3. Patients have received at least 2 different systemic chemotherapy regimens (contained platinum based regimen) , and progressed or relapsed
•4. At least one measurable lesion that can be accurately assessed ( RECIST1.1 criteria). If the only site of measurable disease is in a previously irradiated area, the patient must have documented progression of disease in this area.
•5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
•6. Laboratory criteria are as follows:
•Complete blood count: hemoglobin (Hb) ≥80g/L ; absolute neutrophil count (ANC) ≥1.5×109/L ; platelets \>=75×109/L Biochemistry test: total bilirubin≦1.5×ULN; alanine aminotransferase(ALT) ,aspartate aminotransferase(AST)≦2.5×ULN(ALT,AST≦5×ULN if liver involved); serum creatinine(cr)≦1.5×ULN; Coagulation test: International Normalized Ratio (INR) \< 1.5.
•7. Life expectancy of at least 12 weeks.
•8. All patients must have given signed, informed consent prior to registration on study.

Exclusion Criteria

•1. Patients receiving any anti-cancer therapy (including chemotherapy, target therapy, immunotherapy, radiotherapy, and anti-cancer Chinese traditional medicine, et al) within 4 weeks from the last dose prior to study entry; Subjects receiving any supportive treatment for haematology (including transfusion, blood products, or drugs that stimulate blood cells growth like G-CSF, et al) within 2 weeks from the last dose prior to study entry;
•2. Patients with second primary cancer, except: adequately treated basal cell or squamous cell skin cancer, curatively treated in-situ cancer of the cervix, unless received curative treatment and with documented evidence of no recurrence during the past five years;
•3. Patients with uncontrolled or significant cardiovascular disease, including:
•A) Grade II or higher Congestive heart failure, unstable angina pectoris, myocardial infarction (NYHA Classification) within 6 months prior to study entry; or arrhythmia requiring treatment, or Left Ventricular Ejection Fraction (LVEF) \< 50% during screening stage.
•B) Primary cardiomyopathy (dilated cardiomyopathy, hypertrophic cardiomyocyte, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, et,al).
•C) History of significant QT interval prolongation, or Corrected QT Interval QTc≥450ms(male),QTc≥470ms（female）at screening.
•D) Symptomatic coronary heart disease requiring treatment. E) Uncontrolled hypertension (\> 140/90 mmHg) with single medication.
•4. History of active bleeding within 6 months prior to screening; or patients receiving anticoagulation therapy; or patients with upper GI bleeding potential; or patients with active hemoptysis.
•5. Patients with uncontrolled pleural effusion, pericardial effusion or ascites.
•6. Patients with untreated central nervous system (CNS) metastasis; or requiring corticosteroids, anticonvulsants for CNS diseases treatment; or with evidence of progression or haemorrhage within 1 month prior to study entry; or clinical evidence of brain stem or leptomeninx involvement.
+12 more criteria

Locations (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

November 9, 2017

Primary Completion Date

November 4, 2022

Completion Date

May 15, 2023

Last Updated

August 30, 2023

Enrollment

ACTUAL participants

Conditions

Small Cell Lung Cancer

Interventions

Chiauranib

DRUG

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248

Non-small Cell Lung Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 30, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase Ib/II Study of Chiauranib in Patients With Small Cell Lung Cancer

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

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