Phase 2 Study for the Patient, Who Has Diagnosed With Small Cell Lung Cancer (SCLC) or Non Small Cell Lung Cancer (NSCLC) or Renal Cell Carcinoma (RCC) and Finished the First Line Stand Treatment , Need More Treatment
Small Cell Lung CancerRenal Cell Carcinoma (RCC)Non-Small Cell Lung
Investigational drug(s) / intervention(s)
AL8326 40 mgAL8326 60 mgAL8326 80 mg--stopped
AL8326 40 mg: Taken AL3826 at 40mg QD orally
AL8326 60 mg: Taken AL3826 at 60mg QD orally
AL8326 80 mg--stopped: Taken AL3826 at 80 mg QD orally
Study summary
This trial is a Phase II trial designed to evaluate the safety and efficacy of using oral AL8326 , a multi-targeted receptor Tyrosine Kinase Inhibitor( TKI) , to recurrent, advanced, or metastatic small cell lung cancer (SCLC) patients , Non-Small Cell Lung (NSCLC) and Renal Cell Carcinoma patients who need ≥2nd line treatment .
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Major Inclusion Criteria:
1. Male or female, 18 years of age or older
2. ECOG performance status of 0 or 1
3. Histologically or cytologically confirmed SCLC /NSCLC/RCC
4. Have at least 1 lesion that meets the criteria for being measurable, as defined by RECIST 1.1
5. Have a life expectancy of at least 3 months
Major Exclusion Criteria:
1. Serious, non-healing wound, ulcer or bone fracture
2. Major surgical procedure within 28 days or minor surgical procedure performed within 7 days prior to treatment
3. Active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
4. Clinically significant cardiovascular disease including uncontrolled hypertension; myocardial infarction or unstable angina within 6 months prior to enrollment; New York Heart Association (NYHA) Grade II or greater congestive heart failure serious cardiac arrhythmia requiring medication; and Grade II or greater peripheral vascular disease
5. Hemoptysis within 3 months prior to enrollment
6. Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19 within 14 days prior to enrollment and during the study unless there is an emergent or life-threatening medical condition that required it.
More information available upon request
Primary outcome measure(s)
Optimal biological dose ( OBD ) — 12 months Determine the Optimal biological dose ( OBD ) via evaluation of dose limiting toxicity (DLT) events to decide the dosing using in expanded cohort
Objective Response Rates (ORR) — 12 month Evaluate the efficacy among 3 different dosing groups
ORR evaluation for NSCLC and RCC — 24 month ORR evaluation for NSCLC and RCC
Trial sites (7)
Facility
City
Region
Status
University of Alabama at Birmingham
Birmingham
Alabama
Recruiting
Cleveland Clinic Florida
Weston
Florida
Withdrawn
Northwestern University
Chicago
Illinois
Completed
Siteman Cancer Center, Washington University
St Louis
Missouri
Recruiting
Cleveland Clinic
Cleveland
Ohio
Recruiting
Hospital Universitari Vall d'Hebron
Barcelona
Spain
Recruiting
Hospital Universitario Ramón Y Cajal
Madrid
Spain
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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