A Biomarker Study in Patients Getting Regorafenib for Metastatic Colorectal Cancer

• Status: Terminated
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Georgetown University
• Collaborator: Bayer

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