Clinical trial · Interventional
Regorafenib in Metastatic Colorectal Cancer
Regorafenib in Adults 70 Years or Older With Metastatic Colorectal Cancer: A Phase II Study
NCT02466009CI-TRIAL-00080424completedPhase 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)
The purpose of the study is to measure high grade (3-5) toxicity of regorafenib and to monitor the impact of treatment with regorafenib on the quality of life in older adults with metastatic colorectal cancer.
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 |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Regorafenib | Drug | Regorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Regorafenib
- description
- 120 mg qd, 3 weeks on/1 week off (each cycle is 28 days) Three 40 mg tablets should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (\< 30% fat) breakfast.
- interventionNames
- Drug: Regorafenib
Primary outcomes (1)
- measure
- Number of Subjects Who Experience Grade 3-5 Toxicity as a Measure of Safety and Tolerability.
- timeFrame
- From the date of study entry until 30 days after the last dose of study treatment.
Secondary outcomes (2)
- measure
- Percentage of Subjects Who Responded to Study Treatment
- timeFrame
- From the date of completion of three cycles of treatment until the date of progression of disease as determined by restaging scans up to 2 years.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed colorectal adenocarcinoma * Measurable metastatic disease. * Age +/\> 70 * Progression on standard therapy, not a candidate for further chemotherapy or patient declines other options * Life expectancy \>/= 12 weeks * Able to understand and willing to sign written informed consent. * Laboratory requirements: * Total bili ≤ 1.5 x upper limit or normal * Alanine aminotransferase \& Asparate aminotransferase ≤ 2.5 x upper limit or normal * Serum creatinine ≤ 1.5 x upper limit or normal * International normalized ratio/prothrombin time ≤ 1.5 x upper limit or normal * Platelet count ≥ 100,000, hemoglobin ≥ 9 g/dL * Absolute neutrophil count ≥ 1,500. Blood transfusion to meet the inclusion criteria not be allowed. * Glomerular filtration rate ≥ 60 ml/min * Subjects of childbearing potential must agree to use adequate contraception beginning at the signing informed consent form until at least 3 months after the last dose of study drug. * Must be able to swallow and retain oral medications Exclusion Criteria: * Currently receiving other systemic therapy for metastatic colorectal cancer * Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter study. * Uncontrolled hypertension despite optimal medical management * Active or clinically significant cardiac disease. * Evidence or history of bleeding diathesis or coagulopathy * Any hemorrhage or bleeding event ≥ grade 3 within 4 weeks. * Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident, deep vein thrombosis or pulmonary embolus within 6 months of informed consent * History of other active malignancy within past 2 years. * Patients with phaeochromocytoma * Known history of human immunodeficiency virus infection or current chronic/active hepatitis B or C infection. * Ongoing infection \> grade 2 * Symptomatic metastatic brain or meningeal tumors * Presence of non-healing wound, non-healing ulcer, or bone fracture * Renal failure requiring hemo- or peritoneal dialysis * Dehydration ≥ grade 1 * Patients with seizure disorder requiring medication * Persistent proteinuria ≥ grade 3 Interstitial lung disease with ongoing signs and symptoms at the time of informed consent * Pleural effusion or ascites that causes respiratory compromise, grade 2 dyspnea * History of organ allograft including corneal transplant * Known or suspected allergy or hypersensitivity to the study drug * Any malabsorption condition * Any condition which makes the subject unsuitable for trial participation * Substance abuse, medical, psychological, or social conditions that may interfere with the subject's participation in the study.
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