Small Cell Lung CancerNCT05371899
Mass Balance Study of [14C]Chiauranib
A study testing Chiauranib in people with Small Cell Lung Cancer, run by Chipscreen Biosciences, Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Chiauranib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2022to 18 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
Show all 38Show fewer
- 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
- Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea, intestinal obstruction, After small bowel resection,etc), or undergone gastrectomy, or history of gastrointestinal perforation
- Unhealed diarrhea prior to dosing, or 4 or more episodes of diarrhea within 7 days prior to planned dosing, or habitual diarrhea
- Habitual constipation persists after treatment
- During the screening period, when the urine protein in the routine urine test is ≥2+, a 24-hour urine protein quantitative test should be carried out. Protein ≥2+, quantitative examination <1g/24h can be enrolled
- Active bleeding within 2 months before the first dose, or anticoagulant drugs are being taken during the screening period, or the investigator judges that there is a high risk of bleeding during the screening period
- History of deep vein thrombosis or pulmonary embolism within 6 months before the first dose
- Active infections that require systemic treatment (oral, intravenous infusion) during the screening period
- With clinically significant UTI or genital infection, or with a history of complicated UTI
- Positive for any one of hepatitis B surface antigen, hepatitis B e antigen, hepatitis C antibody, HIV antibody, syphilis antibody and new crown screening
- Any mental or cognitive disorder, that would impair the ability to understand the informed consent document, or the compliance of study
- Allergic to cioroni capsules and its excipients
- Subjects who have taken any drugs known to induce or inhibit hepatic drug metabolism(CYP3A, CYP1A2 and CYP2D6)within 30 days prior to drug administration of the study medication
- Any other condition which is inappropriate for the study according to investigators' judgment
- Binge drinking or drinking greater than 14 units of alcohol per week in the 6 months prior to screening; or alcohol breath test results ≥ 20 mg/dl during the screening period
- Smoking more than 5 cigarettes per day or habitual use of nicotine-containing products within 2 months before screening, or unable to quit during the trial
- Habitual consumption of grapefruit juice or excessive tea, coffee and/or caffeinated beverages and inability to withdraw during the trial
- Drug abuse or drug abuse that affects the evaluation of test results, or a positive urine drug test during the screening period
- Women of childbearing potential not willing to use and utilize an adequate method of contraception (such as intrauterine device, contraceptive and condom) throughout treatment and for at least 12 weeks after the last dose; pregnant or breastfeeding women; the result of urine pregnancy test was positive at screening; Man participants not willing to use and utilize an adequate method of contraception throughout treatment
- Engaged in work requiring prolonged exposure to radioactive conditions; or participated in radiopharmaceutical labeling experiments
- Difficulty of venous blood collection
- Volunteer in any other study within 3 months prior to drug administration, or Volunteer in 3 times or more studies
- Blood donation or lost more than 400mL blood within 3 months prior to the study, or Received blood transfusions within 1 month
- Other situations that the researchers considered unsuitable to enroll the subject
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, 21500
About this study
Official title: Absorption, Metabolism and Excretion of [14C]Chiauranib in Patients With Small Cell Lung Cancer
Chiauranib , which simultaneously targets against VEGFR/Aurora B/CSF-1R, several key kinases involved in tumor angiogenesis, tumor cell mitosis, and chronic inflammatory microenvironment.
Read the 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.
- Conditions
- Small Cell Lung Cancer
- Being tested
- Chiauranib
- Keywords
- Chiauranib, pharmacokinetic characteristics, Small Cell Lung Cancer
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChiauranibDrug
Take Chiauranib 50mg orally once daily
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Chiauranib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tmax
Time to maximum concentration
Measured: The sample collection for the last subject was done, and the safety inspection was performed，assessed up to 22 days
Cmax
Maximum concentration
Measured: 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
Measured: The sample collection for the last subject was done, and the safety inspection was performed，assessed up to 22 days
t1/2
Half life
Measured: The sample collection for the last subject was done, and the safety inspection was performed，assessed up to 22 days
MRT
Mean resident time
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Safety
Measured: The sample collection for the last subject was done, and the safety inspection was performed，assessed up to 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start20 Jul 2022
- Primary completion18 Mar 2024
- Study completion18 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Chipscreen Biosciences, Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chipscreen Biosciences, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianan Huang, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371899
- Sponsor's protocol ID
- CAR109
- Status last verified
- Aug 2023
- First submitted
- 4 May 2022
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorption, Metabolism and Excretion of [14C]Chiauranib in Patients With Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05371899
- Acronym / sponsor ID
- CAR109
- Conditions
- Small Cell Lung Cancer
- Keywords
- Chiauranib, pharmacokinetic characteristics, Small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Chipscreen Biosciences, Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 18 Mar 2024 (actual)
- Study completion
- 18 Mar 2024 (actual)
- First posted
- 12 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chiauranib | Other | Drug: ChiauranibTake 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (38 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChiauranibTake Chiauranib 50mg orally once daily | Drug | Chiauranib |
Primary outcome
Tmax
Time frame: The sample collection for the last subject was done, and the safety inspection was performed，assessed up to 22 days
Time to maximum concentration
Cmax
Time frame: The sample collection for the last subject was done, and the safety inspection was performed，assessed up to 22 days
Maximum concentration
AUC
Time frame: The sample collection for the last subject was done, and the safety inspection was performed，assessed up to 22 days
Area under the plasma concentration-time curve
t1/2
Time frame: The sample collection for the last subject was done, and the safety inspection was performed，assessed up to 22 days
Half life
MRT
Time frame: The sample collection for the last subject was done, and the safety inspection was performed，assessed up to 22 days
Mean resident time
Whole blood/plasma concentration (B/P) ratios for total radioactivity
Time frame: 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
Cumulative amount of radioactivity recovered in urine, feces, and in total
Time frame: 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
Percent of Metabolite in plasma, urine and feces
Time frame: 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
1 secondary outcome
percentage of AEs
Time frame: The sample collection for the last subject was done, and the safety inspection was performed，assessed up to 22 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianan Huang principal investigator
The First Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chiauranib in people with Small Cell Lung Cancer, run by Chipscreen Biosciences, Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tmax (time frame: The sample collection for the last subject was done, and the safety inspection was performed，assessed up to 22 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.