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A Biomarker Study in Patients Getting Regorafenib for Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02402036
Recruitment Status : Terminated
First Posted : March 30, 2015
Results First Posted : January 29, 2019
Last Update Posted : January 29, 2019
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Colon Cancer Drug: Regorafenib Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Regorafenib in Metastatic Colorectal Cancer: An Exploratory Biomarker Study
Actual Study Start Date : February 2015
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Regorafenib

Arm Intervention/treatment
Experimental: Regorafenib
Regorafenib 120 mg orally daily for 21 days out of a 28 day cycle
Drug: Regorafenib
Regorafenib orally for 21 days every 28 day cycle
Other Name: Stivarga




Primary Outcome Measures :
  1. Serum microRNA Quantification [ Time Frame: 2 years ]
    Serum microRNAs will be quantified using miScript MiRNA PCR arrays



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02402036


Locations
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United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Bayer
Investigators
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Principal Investigator: John Marshall, MD Georgetown University
  Study Documents (Full-Text)

Documents provided by Georgetown University:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT02402036    
Other Study ID Numbers: 2014-0133
First Posted: March 30, 2015    Key Record Dates
Results First Posted: January 29, 2019
Last Update Posted: January 29, 2019
Last Verified: November 2017
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases