Clinical trial · Interventional
A Biomarker Study in Patients Getting Regorafenib for Metastatic Colorectal Cancer
Regorafenib in Metastatic Colorectal Cancer: An Exploratory Biomarker Study
NCT02402036CI-TRIAL-00036799terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Regorafenib | Drug | Regorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Regorafenib
- description
- Regorafenib 120 mg orally daily for 21 days out of a 28 day cycle
- interventionNames
- Drug: Regorafenib
Primary outcomes (1)
- measure
- Serum microRNA Quantification
- timeFrame
- 2 years
- description
- Serum microRNAs will be quantified using miScript MiRNA PCR arrays
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDWeinberg 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 28712102