A Biomarker Study in Patients Getting Regorafenib for Metastatic Colorectal Cancer
- Registration Number
- NCT02402036
- Lead Sponsor
- Georgetown University
- Brief Summary
This is an exploratory biomarker study. Patients with metastatic colorectal cancer will receive regorafenib, which is FDA approved in this setting, on day 1-21 of every consecutive 28 day cycle. Patients will be asked to undergo tumor biopsy at baseline and 2 weeks after starting regorafenib. Peripheral blood samples will be collected at baseline 2 weeks after starting regorafenib, after initiation of cycle 3, and every 4 weeks thereafter.
- Detailed Description
Tumor tissue collected at baseline and 2 weeks after starting regorafenib will be analyzed for phosphoproteins and RNA. Peripheral blood samples will be collected and banked for protein, miRNA, and mutated DNA analysis.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
- Metastatic colorectal cancer suitable for regorafenib treatment
- Life expectancy of at least 12 weeks
- Able to understand and willing to sign written informed consent form
- Adequate bone marrow, liver, and renal function
- Glomerular filtration rate >/= 60 according to the Modified Diet in Renal Disease abbreviated formula
- Women of childbearing potential must have a negative serum pregnancy test
- Subject able to swallow and retain oral medication
- Previous assignment to treatment in this study
- Uncontrolled hypertension
- Active or clinically significant cardiac disease
- Evidence or history of Bleeding diathesis or coagulopathy
- Any hemorrhage or bleeding even Grade 3 or higher within 4 weeks prior to start of study medication
- Subjects with thrombotic, embolic, venous or arterial events
- Subjects with any previously untreated or concurrent cancer
- Pheochromocytoma
- Known history of human immunodeficiency virus infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy
- Ongoing infection Grade 2 or higher
- Symptomatic metastatic brain or meningeal tumors
- Presence of a non-healing wound, non-healing ulcer, or bone fracture
- Renal failure requiring dialysis
- Dehydration Grade 1 or higher
- Seizure disorder requiring medication
- Persistent proteinuria Grade 3 or higher
- Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
- Pleural effusion or ascites that causes respiratory compromise
- History of organ allograft including corneal transplant
- Known or suspected allergy or hypersensitivity to the study drug
- Any malabsorption condition
- Women who are pregnancy or breast-feeding
- Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
- Concurrent anticancer therapy
- Concurrent use of another investigational drug or device therapy during or within 4 weeks of trial entry
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication
- Therapeutic anticoagulation with Vitamin-K antagonists or with heparins and heparinoids
- Use of any herbal remedy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Regorafenib Regorafenib Regorafenib 120 mg orally daily for 21 days out of a 28 day cycle
- Primary Outcome Measures
Name Time Method Serum microRNA Quantification 2 years Serum microRNAs will be quantified using miScript MiRNA PCR arrays
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Georgetown University
🇺🇸Washington, District of Columbia, United States