Colon Cancer
Conditions
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.
Interventions
DRUGRegorafenib
Regorafenib orally for 21 days every 28 day cycle
Sponsors
Bayer
Georgetown University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum microRNA Quantification | 2 years | Serum microRNAs will be quantified using miScript MiRNA PCR arrays |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Regorafenib Regorafenib 120 mg orally daily for 21 days out of a 28 day cycle
Regorafenib: Regorafenib orally for 21 days every 28 day cycle | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Regorafenib |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 10 |
| other Total, other adverse events | 10 / 10 |
| serious Total, serious adverse events | 5 / 10 |
Outcome results
Primary
Serum microRNA Quantification
Serum microRNAs will be quantified using miScript MiRNA PCR arrays
Time frame: 2 years
Population: Due to issues with recruitment and the principal investigator leaving the institution, no analysis of the collected samples was performed.