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Panitumumab, Regorafenib, or TAS-102, in Treating Patients With Metastatic and/or Unresectable RAS Wild-Type Colorectal Cancer
Phase 2 trial testing Panitumumab in Metastatic Colon Adenocarcinoma in 12 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 | 12 |
| Start date | 24 April 2020 |
| Primary completion | 1 December 2023 |
| Estimated completion | 7 October 2024 |
| Sites | 18 locations across United States |
Academic and Community Cancer Research United — full company profile →
18 and older, any sex, with Metastatic Colon Adenocarcinoma or Metastatic Colorectal Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
OS is defined as the Time from randomization to death from any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier. Overall survival will be compared between the 2 treatment arms using the un-stratified log-rank test will be used.
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Panitumumab) | 7.5 | 7.2 – NA |
| Arm B (Regorafenib, Trifluridine and Tipiracil Hydrochloride) | 8.3 | 4.9 – NA |
PFS is defined as the time from randomization to documentation of disease progression or death due to any cause, whichever is first. If the patient did not have any disease evaluation post randomization, PFS will be censored at one day after randomization. The distribution of progression free survival will be estimated using the method of Kaplan-Meier. Progression free survival will be compared between the 2 treatment arms using the log-rank test which is used for the primary endpoint analysis.
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Panitumumab) | 5.1 | 2.0 – NA |
| Arm B (Regorafenib, Trifluridine and Tipiracil Hydrochloride) | 3.7 | 2.0 – NA |
Defined as the number of patients with a complete response (CR) or partial response (PR) (as defined by the Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1) divided by the number of evaluable patients in each arm. ORR will be compared between the 2 treatment arms. Confidence intervals for the true success proportion will be calculated according to the approach of Clopper and Pearson.
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Panitumumab) | 20.0 | 0.51 – 71.6 |
| Arm B (Regorafenib, Trifluridine and Tipiracil Hydrochloride) | 0.0 | 0.0 – 45.93 |
Defined as the number of patients with a complete response (CR), partial response (PR), or stable disease for \>= 4 months (as defined by the RECIST 1.1) divided by the number of evaluable patients in each arm. Confidence intervals for the true success proportion will be calculated according to the approach of Clopper and Pearson.
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Panitumumab) | 20.0 | 0.51 – 71.6 |
| Arm B (Regorafenib, Trifluridine and Tipiracil Hydrochloride) | 16.67 | 0.42 – 64.12 |
The maximum grade for each type of adverse event will be recorded for each patient in each cycle. The number of patients experiencing grade 3 or higher adverse events will be compared using Chi-Square or Fisher's Exact tests.
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Panitumumab) | 1 | |
| Arm B (Regorafenib, Trifluridine and Tipiracil Hydrochloride) | 3 |
Time frame: 2 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Arm A (Panitumumab) | Arm B (Regorafenib, Triflu… |
|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | — | — |
| Reaction | System | Arm A (Panitumumab) | Arm B (Regorafenib, Triflu… |
|---|---|---|---|
| Rash acneiform | Skin and subcutaneous tissue disorders | — | — |
| Fatigue | General disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Platelet count decreased | Investigations | — | — |
| Blood bilirubin increased | Investigations | — | — |
| Lymphocyte count decreased | Investigations | — | — |
| Weight loss | Investigations | — | — |
| Hypocalcemia | Metabolism and nutrition disorders | — | — |
| Hypomagnesemia | Metabolism and nutrition disorders | — | — |
| Palmar-plantar erythrodysesthesia syndrm | Skin and subcutaneous tissue disorders | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Blood and lymph sys disorders - Oth Spec | Blood and lymphatic system disorders | — | — |
| Ear pain | Ear and labyrinth disorders | — | — |
| Ascites | Gastrointestinal disorders | — | — |
| Colitis | Gastrointestinal disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Mucositis oral | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Paronychia | Infections and infestations | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Blood bicarbonate decreased | Metabolism and nutrition disorders | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — |
| Hyponatremia | Metabolism and nutrition disorders | — | — |
| Arthritis | Musculoskeletal and connective tissue disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Rotator cuff injury | Musculoskeletal and connective tissue disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Peripheral sensory neuropathy | Nervous system disorders | — | — |
| Depression | Psychiatric disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Sore throat | Respiratory, thoracic and mediastinal disorders | — | — |
| Voice alteration | Respiratory, thoracic and mediastinal disorders | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Skin and subcut tissue disord - Oth spec | Skin and subcutaneous tissue disorders | — | — |
Most-reported serious reactions: Back pain, Muscle weakness lower limb.
Data from ClinicalTrials.gov NCT03992456 adverse events section.
This phase II trial studies how well retreatment with panitumumab works compared to standard of care regorafenib or trifluridine and tipiracil hydrochloride (TAS-102) in treating patients with colorectal cancer that is negative for RAS wild-type colorectal cancer has spread to other places in the body (metastatic), and/or cannot be removed by surgery (unresectable), and is negative for resistance mutations in blood. Treatment with panitumumab may interfere with the ability of tumor cells to grow and spread. Some tumors need growth factors to keep growing. Growth factor antagonists, such as regorafenib, may interfere with the growth factor and stop the tumor from growing. Drugs used in chemotherapy, such as TAS-102, 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. Giving panitumumab may work better in treating patients with colorectal cancer than with the usual treatment of regorafenib or TAS-102.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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