A Biomarker Study in Patients Getting Regorafenib for Metastatic Colorectal Cancer

NCT ID: NCT02402036

Last Updated: 2019-01-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-11-30

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.

Conditions

Colon Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Regorafenib

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

Group Type: EXPERIMENTAL

Regorafenib

Intervention Type: DRUG

Regorafenib orally for 21 days every 28 day cycle

Interventions

Regorafenib

Regorafenib orally for 21 days every 28 day cycle

Intervention Type: DRUG

Other Intervention Names

Stivarga

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Marshall, MD

Role: PRINCIPAL_INVESTIGATOR

Georgetown University

Locations

Georgetown University

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

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28712102 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2014-0133

Identifier Type: -

Identifier Source: org_study_id