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New treatment option for Small Cell Lung Cancer
Official title Chiauranib for Advanced Solid Malignant Tumors and Relapsed/Refractory SCLC.
ClinicalTrials.gov ID: NCT05271292
What this study is testing
What is Chiauranib?
Chiauranib is an investigational medicine, given as an once-daily, being studied as a potential treatment for small cell lung cancer.
Also referred to as CS2164.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 1b/2, single-arm, open-label, dose-escalation study including 2 stages: Phase 1b: Dose-Escalation Stage (Single-Dose and Consecutive-Dose Periods) Phase 2: recommended Phase 2 dose (RP2D) of chiauranib will be given to all patients enrolled in this phase once daily for 28-day cycles continuously with no interruption between cycles.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Phase 1b
- Patient is at least 18 years of age, regardless of gender. Patient has a diagnosis of histologically or cytologically confirmed advanced solid...
- Patient has at least one measurable target lesion as defined by RECIST1.1, i.e., a lesion that has radiologic evidence of disease progression, after...
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at enrollment.
- Major organ functions meet the following criteria (no corrective treatment, such as G CSF, erythropoietin, and blood transfusion, within 2 weeks...
You likely can't join if
- Patient has received any systemic anticancer therapy (including chemotherapy, targeted therapy, biological immunotherapy, any investigational drug...
- Patient with prior or concurrent malignancy whose natural history or treatment has the potential to interfere with safety or how well it works...
- Patient has uncontrolled or significant cardiovascular diseases, including:
- New York Heart Association (NYHA) grade II or higher congestive cardiac failure, unstable angina pectoris, and/or myocardial infarction within the 6...
- Primary cardiomyopathies (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive...
- Clinically significant history of prolonged QTc interval, or QTcF interval \>470ms for females or \>450 ms for males during screening.
See the full eligibility criteria
Who can join
- Phase 1b
- Patient is at least 18 years of age, regardless of gender. Patient has a diagnosis of histologically or cytologically confirmed advanced solid malignant tumor (including SCLC, NSCLC, colorectal carcinoma, pancreatic...
- Patient has at least one measurable target lesion as defined by RECIST1.1, i.e., a lesion that has radiologic evidence of disease progression, after treatment with radiotherapy or local-regional therapy.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at enrollment.
- Major organ functions meet the following criteria (no corrective treatment, such as G CSF, erythropoietin, and blood transfusion, within 2 weeks before enrollment):
- Hematology: absolute neutrophil count (ANC) ≥1.5×109/L, platelet ≥100×109/L, hemoglobin ≥100 g/L.
- Biochemistry: total bilirubin ≤1.25×upper limit of normal (ULN), both alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×ULN (≤5×ULN for patients with hepatic metastasis), creatinine clearance \>60...
- Coagulation panel: international normalized ratio (INR) \<1.5.
- Patient has a life expectancy ≥3 months.
- Patient is able to provide voluntary informed consent.
- Women of childbearing potential (WOCBP) must be willing and able to take highly effective contraceptive measures during the entire study treatment period and for 12 weeks after the last dose of study drug (see Appendix...
- Male patients must be willing and able to use male condoms and their female partners who are WOCBP during the entire study treatment and for the 12 weeks after the last dose of the study drug.
What rules you out
- Patient has received any systemic anticancer therapy (including chemotherapy, targeted therapy, biological immunotherapy, any investigational drug, or anti-cancer herbal medicine) within 21 days before enrollment, or...
- Patient with prior or concurrent malignancy whose natural history or treatment has the potential to interfere with safety or how well it works assessment of investigational regimen.
- Patient has uncontrolled or significant cardiovascular diseases, including:
- New York Heart Association (NYHA) grade II or higher congestive cardiac failure, unstable angina pectoris, and/or myocardial infarction within the 6 months prior to the first dose of the investigational drug, clinically...
- Primary cardiomyopathies (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, indeterminate cardiomyopathy).
- Clinically significant history of prolonged QTc interval, or QTcF interval \>470ms for females or \>450 ms for males during screening.
- Coronary heart disease with symptoms requiring medication.
- Patient has hypertension at screening (defined as systolic blood pressure [SBP] ≥140 mmHg, diastolic blood pressure [DBP] ≥90 mmHg). (Patients with a known history of hypertension if blood pressure is considered well...
- Patient has active hemoptysis, has had active bleeding within 6 months prior to enrollment, or has definite predisposition to gastrointestinal bleeding as determined by the investigator (e.g., esophageal varix...
- Patient has uncontrolled pleural effusion, hydropericardium, or ascites.
- Patient has active or symptomatic central nervous system (CNS) metastases that require treatment.
- Patient has a history of deep vein thrombosis, pulmonary embolism, or other serious thrombotic event within 6 months prior to enrollment.
- Patient has an interstitial lung disease (ILD) that requires treatment, such as idiopathic interstitial pneumonia, pulmonary fibrosis, or evidence of ILD in baseline chest computed tomography (CT) or magnetic resonance...
- Patient has any current toxicity (except alopecia) of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, Grade 2 or higher caused by previous therapy.
- Patient has clinically significant gastrointestinal abnormalities that may affect the intake, transport, or absorption of the study drug (e.g., inability to swallow, chronic diarrhea, intestinal obstruction), or has had...
- Patients has undergone a major surgical operation within 6 weeks prior to screening or a minor surgical operation within 2 weeks prior to screening. A major surgical operation refers to an operation involving general...
- Patient has urine protein ≥2+ by urine routine examination and urine protein ≥1 g/24 h by 24-hour urine protein quantification.
- Patient has serious active infection or known infectious disease including hepatitis B, hepatitis C infection in active stage, or HIV/AIDS.
- Patient has any mental or cognitive impairment that may limit their understanding and implementation of written informed consent and compliance in this study.
- Patient has previously experienced toxicity leading to discontinuation of treatment with Aurora kinase inhibitors or VEGF/VEGFR inhibitors, such as sorafenib, sunitinib, pazopanib, bevacizumab, regorafenib, axitinib...
- Patient has current drug or alcohol abuse disorders that may affect study participation, according to the investigator's judgment.
- Women who are pregnant, planning to become pregnant, lactating, or who have positive pregnancy test results at screening or before the first dose.
- Patients who are currently taking and have to continue taking strong CYP3A4 inhibitor drugs, such as ketoconazole, itraconazole, clarithromycin, telithromycin, nefazodone, atazanavir, darunavir, indinavir, lopinavir...
- Any other conditions that make the patient inappropriate for participation in this study, at the investigator's discretion.
The study team makes the final eligibility decision.
Where it's taking place
- Encinitas, California, United States
- Fullerton, California, United States
- Atlanta, Georgia, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Las Vegas, Nevada, United States
- Canton, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Nashville, Tennessee, United States
- Huntsville, Texas, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Encinitas, California, United States; Fullerton, California, United States; Atlanta, Georgia, United States; Boston, Massachusetts, United States; Detroit, Michigan, United States; Las Vegas, Nevada, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.