Actively Recruiting
Chiauranib for Advanced Solid Malignant Tumors and Relapsed/Refractory SCLC.
Led by Chipscreen Biosciences, Ltd. · Updated on 2024-07-16
36
Participants Needed
11
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Chiauranib for Advanced Solid Malignant Tumors and Relapsed/Refractory SCLC.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is at least 18 years old with a confirmed diagnosis of advanced solid malignant tumor or SCLC that is relapsed, refractory, or lacks standard therapy
- At least one measurable tumor lesion showing progression after prior treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate major organ function without recent corrective treatments
- Life expectancy of at least 3 months
- Able to provide informed consent voluntarily
- Women of childbearing potential willing to use effective contraception during and 12 weeks after treatment
- Male patients willing to use condoms with female partners of childbearing potential during and 12 weeks after treatment
You will not qualify if you...
- Received systemic anticancer therapy within 21 days or blood support therapy within 2 weeks before enrollment
- Taking corticosteroids over 10 mg prednisone or equivalent
- Prior or concurrent malignancy that may interfere with the study
- Uncontrolled or significant cardiovascular diseases, including recent heart failure or myocardial infarction, significant arrhythmia, or low heart function
- Hypertension not well controlled or above defined limits
- Active bleeding, hemoptysis, or bleeding risk conditions
- Uncontrolled pleural effusion, hydropericardium, or ascites
- Active or symptomatic brain metastases needing treatment
- Recent serious thrombotic events within 6 months
- Interstitial lung disease needing treatment or evidence on imaging
- Current toxicity of grade 2 or higher from previous therapy except hair loss
- Significant gastrointestinal issues affecting drug intake or absorption
- Recent major or minor surgery within 6 or 2 weeks respectively
- Significant proteinuria by urine tests
- Serious active infections including hepatitis B, C, or HIV/AIDS
- Mental or cognitive impairment limiting consent or compliance
- Previous toxicity causing stopping Aurora kinase or VEGF/VEGFR inhibitors
- Current drug or alcohol abuse affecting participation
- Pregnancy, breastfeeding, or positive pregnancy test
- Taking strong CYP3A4 inhibitors or inducers during dose escalation phase
- Any other condition deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 11 locations
1
California Cancer Associates-Encintas
Encinitas, California, United States, 92024
Actively Recruiting
2
Providence/St. Joe Cancer Institute/Crosson Cancer Institute
Fullerton, California, United States, 92835
Actively Recruiting
3
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
Dana Farber Cancer Institue
Boston, Massachusetts, United States, 02215
Actively Recruiting
5
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
6
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89119
Actively Recruiting
7
Gabrail Cancer Center Research
Canton, Ohio, United States, 44718
Actively Recruiting
8
OU Health
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
9
Sarah Cannon Research Center
Nashville, Tennessee, United States, 37203
Actively Recruiting
10
North Houston Cancer Clinics
Huntsville, Texas, United States, 77340
Actively Recruiting
11
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
Z
Zhijian Li, MD
CONTACT
L
Liz Wieland
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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