Status and phase
Conditions
Treatments
About
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 who need ≥2nd line treatment .
Full 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.
A phase 2 expansion cohort will be continued if a positive clinical result would have been observed after OBD determination for 40-60 patients. Upon FDA's approval the Phase 2 expansion cohort clinical study will be further expanded to evaluate the safety and efficacy of AL8326 in patients individually with SCLC who need = or >2nd line treatment without or with brain metastasis which is controlled with no active hemorrhage.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Major Inclusion Criteria:
Major Exclusion Criteria:
More information available upon request
Primary purpose
Allocation
Interventional model
Masking
36 participants in 3 patient groups
Loading...
Central trial contact
Judy Chen; Shiying Sprinzl
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal