NCT02402036

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 30, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

January 29, 2019

Completed
Last Updated

January 29, 2019

Status Verified

November 1, 2017

Enrollment Period

2.8 years

First QC Date

February 4, 2015

Results QC Date

December 13, 2018

Last Update Submit

January 9, 2019

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (1)

  • Serum microRNA Quantification

    Serum microRNAs will be quantified using miScript MiRNA PCR arrays

    2 years

Study Arms (1)

Regorafenib

EXPERIMENTAL

Regorafenib 120 mg orally daily for 21 days out of a 28 day cycle

Drug: Regorafenib

Interventions

RegorafenibDRUG

Regorafenib orally for 21 days every 28 day cycle

Also known as: Stivarga
Regorafenib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

Related Publications (1)

  • 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.

    PMID: 28712102DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

regorafenib

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Results Point of Contact

Title
Mohamed Salem, MD
Organization
Levine Cancer Institute-Concord
mohamed.salem@lcic.edu
704-403-1370

Study Officials

  • John Marshall, MD

    Georgetown University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2015

First Posted

March 30, 2015

Study Start

February 1, 2015

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

January 29, 2019

Results First Posted

January 29, 2019

Record last verified: 2017-11

Locations

US(1)