A national, prospective, multi-center, open-label, single arm phase II trial investigating the efficacy and safety of bevacizumab plus erlotinib in patients with advanced cancers which harbors genomic alterations in Krebs cycle
The BRISK study will recruit patients with locally advanced or metastatic solid tumor harboring the genomic alterations in Krebs cycle (e.g. fumarate hydratase, isocitrate dehydrogenase, succinate dehydrogenase) who had disease progression on standard systemic treatment and/or has no standard treatment option, and investigate the efficacy and safety of bevacizumab plus erlotinib.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Patients will receive bevacizumab 10 mg/kg IV over 30-90 minutes every 2 weeks until disease progression or unacceptable toxicity.
Patients will receive elrotinib 150 mg orally once a day continuously until disease progression or unacceptable toxicity.
Chungnam National University Hospital
Daejeon, Chungcheongnam-do, South Korea
RECRUITINGCha University Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
RECRUITINGObjective response rate
Defined as a proportion of complete response (CR) + partial response (PR) according to RECIST v1.1, the fraction with a response (CR+PR) will be reported separately by cohort, along with a 95% confidence interval
Time frame: 12 months after treatment initiation (estimated average)
Progression-free survival
Assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, PFS will be determined using the Kaplan-Meier method, and the curves presented along with a 95% confidence interval on the median PFS
Time frame: Time from study treatment initiation until disease progression or death, assessed up to 1 years from study enrollment (estimated average)12 months after treatment initiation (estimated average)
Overall survival (OS)
The Kaplan-Meier method will be used and the curves presented along with a 95% confidence interval on the median OS
Time frame: Time from study treatment initiation until death from any cause, assessed up to 2 years from study enrollment (estimated average)
Incidence of adverse events
Severity of adverse events will be graded by NCI-CTCAE (National Cancer Institute - Common Terminology Criteria for Adverse Events) v5.0
Time frame: Time from study treatment initiation up to 30 days after last treatment, 12 months after treatment initiation (estimated average)
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Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
RECRUITINGGyeongsang National University Hospital
Jinju, Gyeongsangnam-do, South Korea
RECRUITINGGachon University Gil Medical Center
Incheon, South Korea
RECRUITINGKorea University Anam Hospital
Seoul, South Korea
RECRUITINGYonsei Cancer Hospital
Seoul, South Korea
RECRUITINGAsan Medical Center
Seoul, South Korea
RECRUITINGThe Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, South Korea
RECRUITINGUlsan University Hospital
Ulsan, South Korea
RECRUITING