A Biomarker Study in Patients Getting Regorafenib for Metastatic Colorectal Cancer

Colon Cancer Clinical Trial

Official title:

Regorafenib in Metastatic Colorectal Cancer: An Exploratory Biomarker Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02402036
• Other study ID #: 2014-0133
• Status: Terminated
• Phase: Phase 2
• Start date: February 2015
• Est. completion date: November 2017

Study information

• Verified date: November 2017
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Regorafenib
Regorafenib orally for 21 days every 28 day cycle

Locations

Country	Name	City	State
United States	Georgetown University	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Georgetown University	Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum microRNA Quantification	Serum microRNAs will be quantified using miScript MiRNA PCR arrays	2 years