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Regorafenib Plus 5-Fluorouracil/Leucovorin Beyond Progression in mCRC
Phase 2 trial testing Regorafenib in Colorectal Cancer in 2 participants. Terminated before completion.
| Lead sponsor | Fox Chase Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 2 |
| Start date | 6 October 2017 |
| Primary completion | 2 June 2020 |
| Estimated completion | 2 June 2020 |
| Sites | 1 location across United States |
Fox Chase Cancer Center — full company profile →
18 and older, any sex, with Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
PFS at 2 months in mCRC patients who progress on regorafenib monotherapy and are treated with regorafenib and 5-FU/LV combination therapy.
| Group | Value | 95% CI |
|---|---|---|
| Regorafenib + 5FU/LV Treatment Arm | NA | NA – NA |
Overall survival will be calculated from the day of first treatment until death
| Group | Value | 95% CI |
|---|---|---|
| Regorafenib + 5FU/LV Treatment Arm | NA | NA – NA |
This will be calculated from the day of first treatment dose until disease progression or death, whichever occurs earlier
| Group | Value | 95% CI |
|---|---|---|
| Regorafenib + 5FU/LV Treatment Arm | NA |
Number of toxicities due to combination therapy will be summarized by frequencies and grades of toxicities due to the combination therapy according to CTCAE 4.03 criteria
| Group | Value | 95% CI |
|---|---|---|
| Regorafenib + 5FU/LV Treatment Arm | NA | NA – NA |
Time frame: 3 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Regorafenib + 5FU/LV Treat… |
|---|---|---|
| Moderate Congestive Heart Failure | Blood and lymphatic system disorders | — |
| Reaction | System | Regorafenib + 5FU/LV Treat… |
|---|---|---|
| Diarrhea | Gastrointestinal disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Fatigue | General disorders | — |
| Weight Loss | Investigations | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Dizziness | Nervous system disorders | — |
| Dysgeusia | Nervous system disorders | — |
| Hypertension | Vascular disorders | — |
| Abdominal Pain | Gastrointestinal disorders | — |
| Bloating | Gastrointestinal disorders | — |
| Small Intestinal Obstruction | Gastrointestinal disorders | — |
| Chills | General disorders | — |
| Edema Limbs | General disorders | — |
| Fever | General disorders | — |
| Pain | General disorders | — |
| Infection | Infections and infestations | — |
| Upper Respiratory Infection | Infections and infestations | — |
| Urinary Tract Infection | Infections and infestations | — |
| Wound Infection | Infections and infestations | — |
| Neutrophil Count Decreased | Investigations | — |
| Platelet Count Decreased | Investigations | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — |
| Hoarsness | Respiratory, thoracic and mediastinal disorders | — |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | — |
| Sore Throat | Respiratory, thoracic and mediastinal disorders | — |
| Hypotension | Vascular disorders | — |
| Heart Failure | Cardiac disorders | — |
| Ear Pain | Ear and labyrinth disorders | — |
| Back Pain | Musculoskeletal and connective tissue disorders | — |
| Agitation | Psychiatric disorders | — |
| Insomnia | Psychiatric disorders | — |
| Hematuria | Renal and urinary disorders | — |
| Urinary Frequency | Renal and urinary disorders | — |
| Urinary Urgency | Renal and urinary disorders | — |
| Vaginal Discharge | Reproductive system and breast disorders | — |
| Vaginal Hemorrhage | Reproductive system and breast disorders | — |
Most-reported serious reactions: Moderate Congestive Heart Failure.
Data from ClinicalTrials.gov NCT03099486 adverse events section.
This is a single arm open label pilot phase II trial of Regorafenib PO plus 5-FU/LV infusion in 15 mCRC patients who progressed on prior Regorafenib monotherapy as well as 5-FU containing chemotherapy combinations.The study will enroll mCRC patients with prior progression on standard multi-agent combination chemotherapy and progression on regorafenib monotherapy.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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