NCT05271292 · Chipscreen Biosciences, Ltd.
Chiauranib for Advanced Solid Malignant Tumors and Relapsed/Refractory SCLC.
(SCLC)
What this study is about
This is a Phase 1b/2, single-treatment group$1, where both patients and doctors know the treatment given, gradually increasing doses study including 2 stages: Phase 1b: gradually increasing doses 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.
View original scientific description
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.
Interventions
DRUG
Chiauranib
Phase 1b: Each patient will undergo both a single-dose period (6 days) and a consecutive-dose (1 cycle of 28 days) period Phase 2: Patients will take the RP2D once daily for 28-day cycles continuously with no interruption between cycles
Primary outcome measures
Incidence of adverse events (AEs) and other safety parameters
Time frame: Until 30 days after a patient takes the last dose of the study drug
Number of patients experienced AEs
Incidence and characteristics of DLTs
Time frame: 34 days
Number of patients experienced any dose limited toxicity
MTD and recommended Phase 2 dose (RP2D)
Time frame: 34 days
Determination of recommended phase II dose
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 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. 2. 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. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at enrollment. 4. Major organ functions meet the following criteria (no corrective treatment, such as G CSF, erythropoietin, and blood transfusion, within 2 weeks before enrollment): 1. Hematology: absolute neutrophil count (ANC) ≥1.5×109/L, platelet ≥
Where
- Encinitas, California
- Fullerton, California
- Atlanta, Georgia
- Boston, Massachusetts
- Detroit, Michigan
- Las Vegas, Nevada
- Canton, Ohio
- Oklahoma City, Oklahoma
- Nashville, Tennessee
- Huntsville, Texas
- Fairfax, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 16, 2024 · Source of record for eligibility and locations