NCT05904457

A Phase II Stydy of Bevacizumab Plus Erlotinib in Patients for Krebs Cycle Altered Cancer

A Phase II Clinical Trial of Bevacizumab Plus eRlotinIb in patientS With Advanced Cancer Having Genetic Alterations in Krebs Cycle (BRISK, KCSG AL22-16)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Solid Tumors
• Advanced Solid Tumors
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	bevacizumab	Patients will receive bevacizumab 10 mg/kg IV over 30-90 minutes every 2 weeks until disease progression or unacceptable toxicity.
DRUG	erlotinib	Patients will receive elrotinib 150 mg orally once a day continuously until disease progression or unacceptable toxicity.

Timeline

• Start date: 2023-01-02
• Primary completion: 2025-01-31
• Completion: 2026-01-31
• First posted: 2023-06-15
• Last updated: 2023-06-15

Locations

10 sites across 1 country: South Korea