Clinical trial · Interventional
A Trial of Trametinib and Panitumumab in RAS/RAF Wild Type Advanced Colorectal Cancer
Molecular Basket Trial In Multiple Malignancies With Common Target Pathway Aberrancies
- 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 a phase 2 study (the second phase in testing a new drug or drug combination) to see how useful the combination of two drugs, panitumumab and trametinib, are in patients with advanced colorectal cancer with KRAS, NRAS, or BRAF wild type (genes that are not mutated). Panitumumab is a drug that is approved by Health Canada for the treatment of advanced colorectal cancer with KRAS wild type. Panitumumab works by binding to and blocking the protein, epidermal growth factor receptor (EGFR) from working. Trametinib is a drug that is approved by Health Canada for the treatment of melanoma with a mutation in the BRAF gene. Trametinib works by binding to and blocking mitogen-activated protein kinase kinase (MEK) 1 and MEK2 from working. Previous studies have shown that the combination of panitumumab and trametinib may be more useful in KRAS, NRAS, or BRAF wild type colorectal cancer.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRAF Wildtype | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| KRAS Wildtype | — | UNRESOLVED | — |
| NRAS Wildtype | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Panitumumab | Drug | Panitumumab | ALIAS |
| Trametinib | Drug | Trametinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Trametinib and Panitumumab
- description
- Trametinib: 2 mg QD, orally, continuously. Panitumumab: 6 mg/kg, intravenously, Q2W
- interventionNames
- Drug: Trametinib
- Drug: Panitumumab
Primary outcomes (1)
- measure
- Percentage of patients who experience complete response, partial response, or stable disease
- timeFrame
- 24 weeks
- description
- by RECIST 1.1 criteria
Secondary outcomes (4)
- measure
- Frequency and proportion of patients who experience side effects.
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age or older * KRAS/NRAS/BRAF wild type colorectal cancer, not responsive to standard therapies, no approved or curative therapy, refuse standard therapy * Prior 5-FU, oxaliplatin and irinotecan * ECOG Performance Status of 0 or 1 * Able to swallow/retain oral drugs * Able and agree to have provide tumor tissue/have biopsies * Agree to use contraception * Not pregnant * Adequate organ system function Exclusion Criteria: * Chemotherapy, radiotherapy, immunotherapy, or other anti-cancer therapies \<28 days or 5 half lives * Prior EGFR, MEK, or RAF inhibitor or regorafenib * Current use of prohibited medications * Unresolved side effects * GI disease or other condition affecting GI absorption * Mucosal or internal bleeding * Any major surgery \<four weeks * HIV, HBV, or HCV positive * Active infection * Leptomeningeal disease * Brain metastases * Unacceptable QTcF interval * Significant uncontrolled arrhythmias * Acute coronary syndromes, myocardial infarction, coronary angioplasty, or stenting or bypass grafting \< 6 mos. * Class II, III, or IV heart failure * Other clinically significant ECGs * Intra - cardiac defibrillators * Cardiac metastases * Condition that may interfere with patient safety * Hypersensitivity to study drugs * Severe or uncontrolled systemic diseases * Pregnant or lactating * Retinal vein occlusion * Interstitial lung disease or pneumonitis * Active liver or biliary disease
References
Publications (1)
- DERIVEDAlshammari K, Aung KL, Zhang T, Razak ARA, Serra S, Stockley T, Wang L, Nguyen J, Spreafico A, Hansen AR, Zwir D, Siu LL, Bedard PL. Phase II Trial of Trametinib and Panitumumab in RAS/RAF Wild Type Metastatic Colorectal Cancer. Clin Colorectal Cancer. 2021 Dec;20(4):334-341. doi: 10.1016/j.clcc.2021.07.004. Epub 2021 Jul 24. PMID 34417144