Phase I Clinical Trial of CA-4948 (Emavusertib) in Combination With FOLFOX Plus Bevacizumab as Frontline Treatment in Patients With Metastatic Colorectal Cancer
National Cancer Institute (NCI)
Summary
This phase I trial studies the side effects and best dose of CA-4948 when given together with fluorouracil, leucovorin, oxaliplatin (FOLFOX) plus bevacizumab in treating patients with colorectal cancer that has spread from where it first started (primary site) to other places in the body (metastatic). CA-4948 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The chemotherapy drugs used in FOLFOX, fluorouracil and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Leucovorin is used with fluorouracil to treat colorectal cancer. Bevacizumab is in a class of medications called anti-angiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to the tumor. This may slow the growth and spread of the tumor. Giving CA-4948 with FOLFOX plus bevacizumab may be safe, tolerable and/or effective in treating patients with metastatic colorectal cancer.
Description
PRIMARY OBJECTIVES: I. To assess dose-limiting toxicities (DLTs) and determine the recommended phase 2 dose (RP2D) of CA-4948 (emavusertib) in combination with leucovorin (folinic acid), fluorouracil, and oxaliplatin (FOLFOX) plus bevacizumab in first-line treatment for patients with advanced or metastatic non-operable colorectal cancer (mCRC). II. To evaluate the safety and tolerability of the combination of CA-4948 (emavusertib) and FOLFOX plus bevacizumab. SECONDARY OBJECTIVES: I. To observe and record anti-tumor activity. II. To evaluate ribonucleic acid sequencing (RNAseq) data to exa…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have histologically or cytologically confirmed colorectal adenocarcinoma * Patients must have unresectable or metastatic measurable disease on imaging for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 determination within 28 days of registration * For patients enrolling to the expansion cohort, lesions must be amenable to research biopsy * Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of CA-4948 (emavusertib) and FOLFOX in combination with bevacizumab in patients \< 18 years of age, children are exclu…
Interventions
- BiologicalBevacizumab
Given IV
- ProcedureBiopsy Procedure
Undergo tumor biopsy
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureComputed Tomography
Undergo CT or PET/CT
- BiologicalEmavusertib
Given PO
- DrugFluorouracil
Given IV
- DrugLeucovorin Calcium
Given IV
Locations (13)
- UF Health Cancer Institute - GainesvilleGainesville, Florida
- Memorial Hospital EastShiloh, Illinois
- University of Kansas Clinical Research CenterFairway, Kansas
- University of Kansas Cancer CenterKansas City, Kansas
- University of Kansas Hospital-Indian Creek CampusOverland Park, Kansas
- University of Kansas Hospital-Westwood Cancer CenterWestwood, Kansas