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Mass Balance Study of [14C]Chiauranib | Clinical Trials | Clareo Health

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Mass Balance Study of [14C]Chiauranib

Absorption, Metabolism and Excretion of [14C]Chiauranib in Patients With Small Cell Lung Cancer

NCT05371899•Chipscreen Biosciences, Ltd.

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 , 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. This trial is a material balance study of \[14C\]Chiauranib in participants with small cell lung cancer, with the goal of learning more about the drug's absorption, metabolism, and excretion in the human body, as well as monitoring the subjects' safety after treatment. Chiauranib's scientific foundation for future progress.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Ages: 18 Years to 75 Years
•Cytologically or histologically confirmed small cell lung cancer
•After normal therapy, disease progression or returnrecurrence
•Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
•Life expectancy of at least 3 months
•Laboratory criteria are as follows:
•* Complete blood count: absolute neutrophil count (ANC) ≥1.5×10\^9/L ; platelets ≥75×10\^9/L; hemoglobin (Hb) ≥80g/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.
•All patients must have given signed, informed consent prior to registration on study

Exclusion Criteria

•Patients experiencing neurological symptoms due to liver or brain metastases
•Patients with hemoptysis or tumor invading around important blood vessels and hemoptysis during the screening period
•Pleural fluid, ascites, pericardial effusion with clinical symptoms and need to be drained during the screening period
•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
•Sunitinib, bevacizumab, anlotinib, apatinib, endostat, and other Aurora kinase inhibitors or VEGF/VEGFR inhibitors were used to treat this small cell lung cancer
•Patients have used any anti-cancer therapy, including, chemotherapy, immunotherapy, target therapy, and other anti-tumor treatments within 14 days before the first dose, Patients have used adiotherapy within 14 days before the first dose
•Patients received major surgical operations within 28 days before the first dose, or patients with serious non-healing wounds, ulcer or fracture at the time of screening
•With the exception of alopecia, any ongoing toxicities (\>CTCAE grade 1) caused by previous cancer therapy
•Abnormal and clinically significant ophthalmic examination
•Patients with uncontrolled or significant cardiovascular disease, including:
+28 more criteria

Locations (1)

The First Affiliated Hospital of Suzhou University

Suzhou, Jiangsu, China

Key Dates

Start Date

July 20, 2022

Primary Completion Date

March 18, 2024

Completion Date

March 18, 2024

Last Updated

July 15, 2024

Enrollment

ACTUAL participants

Conditions

Small Cell Lung Cancer

Interventions

Chiauranib

DRUG

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NCT07485114

Renal Cell Carcinoma (Kidney Cancer)Non Small Cell Lung Cancer+2 more

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RECRUITINGPHASE3

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Non-small Cell Lung Cancer (NSCLC)

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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: July 15, 2024Data 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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Mass Balance Study of [14C]Chiauranib

Inclusion Criteria

Exclusion Criteria

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

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

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)