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Official Title

A Phase 1b/2, Single-Arm, Open-Label, Dose-Escalation, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Chiauranib for the Treatment of Advanced Solid Tumors and Relapsed/Refractory SCLC

Phase
Phase 1/Phase 2
Sponsor
Chipscreen Biosciences, Ltd.
Enrollment
36
Timeline
Aug 2022 → May 2025
About This Study

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.

Eligibility Criteria

Inclusion Criteria

  • 1Patient 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 carcinoma, hepatocellular carcinoma, ovarian cancer, neuroendocrine tumors, non-Hodgkin's lymphoma, and others) that has relapsed from or is refractory to standard therapy or for which no standard therapy exists.
  • 2Patient 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.
  • 3Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at enrollment.
  • 4Major organ functions meet the following criteria (no corrective treatment, such as G CSF, erythropoietin, and blood transfusion, within 2 weeks before enrollment):
  • 5Hematology: absolute neutrophil count (ANC) ≥1.5×109/L, platelet ≥100×109/L, hemoglobin ≥100 g/L.
  • 6Biochemistry: 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 mL/min (according to Cockcroft-Gault equation), fasting triglyceride ≤3.0 mmol/L, fasting total cholesterol ≤7.75 mmol/L.
  • 7Coagulation panel: international normalized ratio (INR) \<1.5.
  • 8Patient has a life expectancy ≥3 months.
  • 9Patient is able to provide voluntary informed consent.
  • 10Women 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 11.7). Women of childbearing potential include premenopausal and not sterilized (by hysterectomy, bilateral ligation of fallopian tubes, or bilateral oophorectomy) females who have passed menarche.
  • 11Male 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.

Exclusion Criteria

  • 1Patient 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 any blood support therapy (including blood transfusion, blood products, or hematopoiesis stimulating agents such as granulocyte-colony stimulating factor \[G-CSF\]) within 2 weeks before enrollment.
  • 2a. Patients who are receiving corticosteroids at a dose of \> 10 mg prednisone or equivalent of other systemic steroids will be excluded.
  • 3Patient with prior or concurrent malignancy whose natural history or treatment has the potential to interfere with safety or efficacy assessment of investigational regimen.
  • 4Patient has uncontrolled or significant cardiovascular diseases, including:
  • 5New 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 significant arrhythmia unable to be controlled with medical treatment or left ventricular ejection fraction (LVEF) \< 50% at screening.
  • 6Primary cardiomyopathies (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, indeterminate cardiomyopathy).
  • 7Clinically significant history of prolonged QTc interval, or QTcF interval \>470ms for females or \>450 ms for males during screening.
  • 8Coronary heart disease with symptoms requiring medication.
  • 9Patient 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 controlled on a single anti-hypertensive medication (systolic blood pressure \<140 mmHg and diastolic blood pressure \<90 mmHg at screening) and in whom there has been no change in blood pressure medication for 3 months prior to screening due to poor control.)
  • 10Patient 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 associated with bleeding risk, local active ulcer lesions).
  • 11Patient has uncontrolled pleural effusion, hydropericardium, or ascites.
  • 12Patient has active or symptomatic central nervous system (CNS) metastases that require treatment.
  • 13Patient has a history of deep vein thrombosis, pulmonary embolism, or other serious thrombotic event within 6 months prior to enrollment.
  • 14Patient 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 imaging (MRI).
  • 15Patient 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.
  • 16Patient 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 total gastrectomy, according to the investigator's judgment.
  • 17Patients 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 anesthesia but excludes procedures such as endoscopies for diagnostic purpose or an implantation of vascular access devices.
  • 18Patient has urine protein ≥2+ by urine routine examination and urine protein ≥1 g/24 h by 24-hour urine protein quantification.
  • 19Patient has serious active infection or known infectious disease including hepatitis B, hepatitis C infection in active stage, or HIV/AIDS.
  • 20Patient has any mental or cognitive impairment that may limit their understanding and implementation of written informed consent and compliance in this study.
  • 21Patient 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, vandetanib, or dasatinib.
  • 22Patient has current drug or alcohol abuse disorders that may affect study participation, according to the investigator's judgment.
  • 23Women who are pregnant, planning to become pregnant, lactating, or who have positive pregnancy test results at screening or before the first dose.
  • 24Patients who are currently taking and have to continue taking strong CYP3A4 inhibitor drugs, such as ketoconazole, itraconazole, clarithromycin, telithromycin, nefazodone, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, or tipranavir, as well as strong CYP3A4 inducers, such as rifampin, dexamethasone, carbamazepine, during Phase 1b (dose escalation stage) of the study.
  • 25Any other conditions that make the patient inappropriate for participation in this study, at the investigator's discretion.

Locations

11 sites participating in this study

Winship Cancer Institute of Emory University

Atlanta, Georgia 30322

Recruiting

Jennifer Carlisle

California Cancer Associates-Encintas

Encinitas, California 92024

Recruiting

Alberto Besseduo, MD

Providence/St. Joe Cancer Institute/Crosson Cancer Institute

Fullerton, California 92835

Recruiting

Yung Lyou, MD

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →