search
Back to results

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
Georgetown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Colon Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 4, 2015
Last Updated
January 9, 2019
Sponsor
Georgetown University
Collaborators
Bayer
search

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

Learn more about this trial

A Biomarker Study in Patients Getting Regorafenib for Metastatic Colorectal Cancer

We'll reach out to this number within 24 hrs