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Washington, District of Columbia 20007


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - 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 Exclusion Criteria: - 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


NCT ID:

NCT02402036


Primary Contact:

Principal Investigator
John Marshall, MD
Georgetown University


Backup Contact:

N/A


Location Contact:

Washington, District of Columbia 20007
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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