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Regorafenib, With Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer
Phase 2 trial testing Cetuximab in BRAF V600E Negative in 22 participants. Participants enrolled and being followed up; not accepting new ones.
| Lead sponsor | Academic and Community Cancer Research United |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 22 |
| Start date | 3 March 2020 |
| Primary completion | 5 September 2023 |
| Estimated completion | 31 March 2025 |
| Sites | 15 locations across United States |
Academic and Community Cancer Research United — full company profile →
18 and older, any sex, with BRAF V600E Negative or KRAS Gene Mutation Negative. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The median OS and 95% confidence intervals in each arm will be reported.
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Regorafenib) | 3.6 | 0.7 – NA |
| Arm B (Cetuximab, Panitumumab, Irinotecan) | 13.3 | 7.9 – NA |
The median first PFS and 95% confidence intervals in each arm will be reported.
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Regorafenib) | 1.2 | 0.7 – NA |
| Arm B (Cetuximab, Panitumumab, Irinotecan) | 7.0 | 3.9 – NA |
The median second PFS and 95% confidence intervals in each arm will be reported.
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Regorafenib) | 2.3 | NA – NA |
| Arm B (Cetuximab, Panitumumab, Irinotecan) | 1.8 | 1.8 – NA |
The median PFS while on sequential treatment and 95% confidence intervals in each arm will be reported.
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Regorafenib) | 3.6 | 0.7 – NA |
| Arm B (Cetuximab, Panitumumab, Irinotecan) | 8.9 | 5.9 – NA |
Point estimates and the corresponding 95% confidence intervals for the true success proportions in each arm will be reported.
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Regorafenib) | 0 | |
| Arm B (Cetuximab, Panitumumab, Irinotecan) | 0 |
Point estimates and the corresponding 95% confidence intervals for the true success proportions will be reported.
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Regorafenib) | 0 | |
| Arm B (Cetuximab, Panitumumab, Irinotecan) | 0 |
The number of patients who experience a grade 3 or higher adverse event (Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v.\] 5.0), regardless of attribution, will be reported by arm.
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Regorafenib) | 4 | |
| Arm B (Cetuximab, Panitumumab, Irinotecan) | 2 |
Time frame: 20 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Arm A (Regorafenib) | Arm B (Cetuximab, Panitumu… | Crossover From Arm A | Crossover From Arm B |
|---|---|---|---|---|---|
| Blood and lymph sys disorders - Oth Spec | Blood and lymphatic system disorders | — | — | — | — |
| Leukocytosis | Blood and lymphatic system disorders | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — |
| Colonic hemorrhage | Gastrointestinal disorders | — | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — | — |
| Dry mouth | Gastrointestinal disorders | — | — | — | — |
| Enterovesical fistula | Gastrointestinal disorders | — | — | — | — |
| Gastrointestinal disorders - Oth spec | Gastrointestinal disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
| Chills | General disorders | — | — | — | — |
| Death NOS | General disorders | — | — | — | — |
| Disease progression | General disorders | — | — | — | — |
| Fatigue | General disorders | — | — | — | — |
| Gen disord and admin site conds-Oth spec | General disorders | — | — | — | — |
| Hepatobiliary disorders - Other, specify | Hepatobiliary disorders | — | — | — | — |
| Sepsis | Infections and infestations | — | — | — | — |
| Skin infection | Infections and infestations | — | — | — | — |
| Fall | Injury, poisoning and procedural complications | — | — | — | — |
| Blood bilirubin increased | Investigations | — | — | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — | — | — |
| Hypocalcemia | Metabolism and nutrition disorders | — | — | — | — |
| Hypomagnesemia | Metabolism and nutrition disorders | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Flank pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Reaction | System | Arm A (Regorafenib) | Arm B (Cetuximab, Panitumu… | Crossover From Arm A | Crossover From Arm B |
|---|---|---|---|---|---|
| Fatigue | General disorders | — | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — | — |
| Hypertension | Vascular disorders | — | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — | — |
| Palmar-plantar erythrodysesthesia syndrm | Skin and subcutaneous tissue disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Alkaline phosphatase increased | Investigations | — | — | — | — |
| Hypomagnesemia | Metabolism and nutrition disorders | — | — | — | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — | — | — | — |
| Anemia | Blood and lymphatic system disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — | — | — |
| Rash acneiform | Skin and subcutaneous tissue disorders | — | — | — | — |
| Blood bilirubin increased | Investigations | — | — | — | — |
| Weight loss | Investigations | — | — | — | — |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — | — | — |
| Skin and subcut tissue disord - Oth spec | Skin and subcutaneous tissue disorders | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — |
| Mucositis oral | Gastrointestinal disorders | — | — | — | — |
| Neutrophil count decreased | Investigations | — | — | — | — |
| Platelet count decreased | Investigations | — | — | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — | — | — |
| Peripheral sensory neuropathy | Nervous system disorders | — | — | — | — |
| Urinary tract obstruction | Renal and urinary disorders | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Dry skin | Skin and subcutaneous tissue disorders | — | — | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — | — | — |
| Blood and lymph sys disorders - Oth Spec | Blood and lymphatic system disorders | — | — | — | — |
| Leukocytosis | Blood and lymphatic system disorders | — | — | — | — |
| Dry eye | Eye disorders | — | — | — | — |
| Ascites | Gastrointestinal disorders | — | — | — | — |
| Bloating | Gastrointestinal disorders | — | — | — | — |
| Enterocolitis | Gastrointestinal disorders | — | — | — | — |
| Flatulence | Gastrointestinal disorders | — | — | — | — |
| Gastrointestinal disorders - Oth spec | Gastrointestinal disorders | — | — | — | — |
| Stomach pain | Gastrointestinal disorders | — | — | — | — |
| Gen disord and admin site conds-Oth spec | General disorders | — | — | — | — |
| Malaise | General disorders | — | — | — | — |
Most-reported serious reactions: Blood and lymph sys disorders - Oth Spec, Leukocytosis, Abdominal pain, Colonic hemorrhage, Diarrhea, Dry mouth, Enterovesical fistula, Gastrointestinal disorders - Oth spec.
Data from ClinicalTrials.gov NCT04117945 adverse events section.
This phase II trial how well regorafenib and anti-EGFR therapy (cetuximab or panitumumab) works for the treatment of patients with colorectal cancer that cannot be removed by surgery (unresectable), has spread to nearby tissue or lymph nodes (locally advanced), or has spread to other places in the body (metastatic). Regorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab or panitumumab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The purpose of this research study is to compare the effects, good and/or bad, of taking regorafenib follow by cetuximab or panitumumab, to those that receive cetuximab or panitumumab before regorafenib.
5 peer-reviewed publications reference this trial (live from Europe PMC):
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