Clinical trial NCT02402036: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Colon Cancer
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2015-03-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Serum microRNA Quantification
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
Study officials:
affiliation: Georgetown University
name: John Marshall, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.