A Phase 2 Evaluation of the Safety and Efficacy of Veonetinib (AL8326) in ≥2nd Line Small Cell Lung Cancer (SCLC), Non Small Cell Lung Cancer (NSCLC) and Renal Cell Carcinoma (RCC) Treatment
Advenchen Pharmaceuticals, LLC.
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 .
Description
This study is designed for two steps: Phase 2 Optimal Biological Dose (OBD) finding and Phase 2 expansion cohort study after OBD determination. The Phase 2 study aims to find optimal biological dose (OBD) initially. Patients will be randomized to 3 different dosing groups in OBD finding cohorts. Each cohort will enroll 6-12 SCLC patients who need ≥2nd line treatment without or with brain metastasis which is controlled with no active hemorrhage. This OBD finding cohort will also evaluate the pharmacokinetic profile of AL8326. OBD patient enrollment of 40 mg (n=12) and 60 mg (N=12) have been c…
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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…
Interventions
- DrugAL8326 40 mg
Taken AL3826 at 40mg QD orally
- DrugAL8326 60 mg
Taken AL3826 at 60mg QD orally
- DrugAL8326 80 mg--stopped
Taken AL3826 at 80 mg QD orally
Locations (7)
- University of Alabama at BirminghamBirmingham, Alabama
- Cleveland Clinic FloridaWeston, Florida
- Northwestern UniversityChicago, Illinois
- Siteman Cancer Center, Washington UniversitySt Louis, Missouri
- Cleveland ClinicCleveland, Ohio
- Hospital Universitari Vall d'HebronBarcelona