Mass Balance Study of [14C]Chiauranib

NCT05371899 | Completed DMC

• 1 other identifier: CAR109
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Small Cell Lung Cancer

Keywords

Chiauranib; pharmacokinetic characteristics; Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (8)

• Tmax

  Time to maximum concentration

  The sample collection for the last subject was done, and the safety inspection was performed，assessed up to 22 days

• Cmax

  Maximum concentration

  The sample collection for the last subject was done, and the safety inspection was performed，assessed up to 22 days

• AUC

  Area under the plasma concentration-time curve

  The sample collection for the last subject was done, and the safety inspection was performed，assessed up to 22 days

• t1/2

  Half life

  The sample collection for the last subject was done, and the safety inspection was performed，assessed up to 22 days

• MRT

  Mean resident time

  The sample collection for the last subject was done, and the safety inspection was performed，assessed up to 22 days

• Whole blood/plasma concentration (B/P) ratios for total radioactivity

  Whole blood/plasma concentration (B/P) ratios for total radioactivity

  The sample collection for the last subject was done, and the safety inspection was performed，assessed up to 22 days

• Cumulative amount of radioactivity recovered in urine, feces, and in total

  Cumulative amount of radioactivity recovered in urine, feces, and in total

  The sample collection for the last subject was done, and the safety inspection was performed，assessed up to 22 days

• Percent of Metabolite in plasma, urine and feces

  Percent of Metabolite in plasma, urine and feces

  The sample collection for the last subject was done, and the safety inspection was performed，assessed up to 22 days

Secondary Outcomes (1)

• percentage of AEs

  The sample collection for the last subject was done, and the safety inspection was performed，assessed up to 22 days

Study Arms (1)

Chiauranib

OTHER

Take 50 mg ChiauranibCioroni capsules orally on an empty stomach once a day, every day; except on the eighth day 8, when you start taking Cioroni capsules liquid, take a single oral dose of \~50 mg/about 100 Ci of \[14C\]Chiauranib suspensionCioroni solution once on an empty stomach.

Drug: Chiauranib

Interventions

Chiauranib DRUG

Take Chiauranib 50mg orally once daily

Chiauranib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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.
• Primary cardiomyopathy (dilated cardiomyopathy, hypertrophic cardiomyocyte, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, et,al).
• History of significant QT interval prolongation, or Corrected QT Interval QTc≥450ms(male),QTc≥470ms（female）at screening.
• patient's treatment record of using at least 2 antihypertensive drugs at the same Within 14 days before the first dose, or uncontrolled hypertension (\> 140/90 mmHg) during the screening period.
• Lung disease that seriously affects ventilation or diffusing function during the screening period

Sponsors & Collaborators

• Chipscreen Biosciences, Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Suzhou University

Suzhou, Jiangsu, 21500, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

chiauranib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jianan Huang

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 12, 2022
• Study Start: July 20, 2022
• Primary Completion: March 18, 2024
• Study Completion: March 18, 2024
• Last Updated: July 15, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)