A Biomarker Study in Patients Getting Regorafenib for Metastatic Colorectal Cancer
Primary Purpose
Colon Cancer
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Regorafenib
Sponsored by
About this trial
This is an interventional basic science trial for Colon Cancer
Eligibility 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
Sites / Locations
- Georgetown University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Regorafenib
Arm Description
Regorafenib 120 mg orally daily for 21 days out of a 28 day cycle
Outcomes
Primary Outcome Measures
Serum microRNA Quantification
Serum microRNAs will be quantified using miScript MiRNA PCR arrays
Secondary Outcome Measures
Full Information
NCT ID
NCT02402036
First Posted
February 4, 2015
Last Updated
January 9, 2019
Sponsor
Georgetown University
Collaborators
Bayer
1. Study Identification
Unique Protocol Identification Number
NCT02402036
Brief Title
A Biomarker Study in Patients Getting Regorafenib for Metastatic Colorectal Cancer
Official Title
Regorafenib in Metastatic Colorectal Cancer: An Exploratory Biomarker Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Study Start Date
February 2015 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Georgetown University
Collaborators
Bayer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Regorafenib
Arm Type
Experimental
Arm Description
Regorafenib 120 mg orally daily for 21 days out of a 28 day cycle
Intervention Type
Drug
Intervention Name(s)
Regorafenib
Other Intervention Name(s)
Stivarga
Intervention Description
Regorafenib orally for 21 days every 28 day cycle
Primary Outcome Measure Information:
Title
Serum microRNA Quantification
Description
Serum microRNAs will be quantified using miScript MiRNA PCR arrays
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Marshall, MD
Organizational Affiliation
Georgetown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28712102
Citation
Weinberg BA, Hartley ML, Salem ME. Precision Medicine in Metastatic Colorectal Cancer: Relevant Carcinogenic Pathways and Targets-PART 2: Approaches Beyond First-Line Therapy, and Novel Biologic Agents Under Investigation. Oncology (Williston Park). 2017 Jul 15;31(7):573-80.
Results Reference
derived
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A Biomarker Study in Patients Getting Regorafenib for Metastatic Colorectal Cancer
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