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Small Cell Lung CancerPhase 1NCT03216343

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

A Phase 1 study testing Chiauranib in people with Small Cell Lung Cancer, run by Chipscreen Biosciences, Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
48 participants
Where
1 siteChina
Study dates
9 Nov 2017to 15 May 2023
Phase
Phase 1
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

  • Male or female, age ≥ 18 years and ≤75 years;
  • Cytologically or histologically confirmed small cell lung cancer;
  • Patients have received at least 2 different systemic chemotherapy regimens (contained platinum based regimen) , and progressed or relapsed
  • 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.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Laboratory criteria are as follows:
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  • 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.
  • Life expectancy of at least 12 weeks.
  • All patients must have given signed, informed consent prior to registration on study.

Who cannot join

  • 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;
  • 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;
  • 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.
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  • Symptomatic coronary heart disease requiring treatment. E) Uncontrolled hypertension (> 140/90 mmHg) with single medication.
  • 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.
  • Patients with uncontrolled pleural effusion, pericardial effusion or ascites.
  • 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.
  • History of deep vein thrombosis or pulmonary embolism.
  • History of interstitial lung disease(ILD).
  • With the exception of alopecia, any ongoing toxicities (>CTCAE grade 1) caused by previous cancer therapy.
  • Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea, intestinal obstruction etc), or undergone gastrectomy. .
  • 6 weeks or less from the last major surgery that involved general anaesthesia, or 2 weeks or less from the last minor surgery prior to screening (excluding placement of vascular access ) .
  • Proteinuria positive(≥1g/24h).
  • Patients with active or unable to control infections including human immunodeficiency virus (HIV), hepatitis B, or hepatitis C, or other serious infectious diseases.
  • Any mental or cognitive disorder, that would impair the ability to understand the informed consent document, or the compliance of study;
  • Any previous treatment with aurora kinase inhibitors, or VEGF/VEGFR inhibitors.
  • Candidates with drug and alcohol abuse.
  • 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.
  • Any other condition which is inappropriate for the study according to investigators' judgment.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality

Other trials in China

About this study

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

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 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.

Being tested
Chiauranib
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

    CS2164

Study groups in NCT03216343
Study groupRoleWhat they receive
Study ArmExperimentalPatients take Chiauranib capsules 50mg, orally once daily, 28 days as a cycle until objective disease progression
Receives: Drug: Chiauranib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective reponse rate(ORR)

    ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

    Measured: Up to a minimum 24 weeks after the last participant's first dose, or progression, or 75% subjects died.

Secondary outcomes (6)

  1. Number of subjects with Adverse Events as a Measure of Safety and Tolerability

    Safety evaluation as measured by adverse events (AE), vital signs，electrocardiograph(ECG) and abnormal laboratory results according to CTCAE V4.03

    Measured: Up to a minimum 28 weeks after the last participant's first dose, or progression, or 75% subjects died.

  2. Disease-control rate (DCR)

    Measured: Up to a minimum 24 weeks after the last participant's first dose, or progression, or 75% subjects died.

  3. Time to progression(TTP)

    Measured: From date of the first dose of study drug until the date of first documented progression NOT including death, assessed up to 24 months

  4. Duration of response (DOR)

    Measured: from the date of first documented objective response until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

  5. Progression-free survival (PFS)

    Measured: From date of the first dose of study drug until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

  6. Overall survival (OS)

    Measured: From date of the first dose of study drug until the date of death from any cause, assessed up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2017
  2. Study start9 Nov 2017
  3. Primary completion4 Nov 2022
  4. Study completion15 May 2023

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03216343
Sponsor's protocol ID
CAR105
Status last verified
May 2023
First submitted
10 Jul 2017
Last updated
30 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 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 9 inclusion and 22 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 30 Aug 2023. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Objective reponse rate(ORR) (time frame: Up to a minimum 24 weeks after the last participant's first dose, or progression, or 75% subjects died.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03216343.

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 30 Aug 2023.

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