A Trial of Trametinib and Panitumumab in RAS/RAF Wild Type Advanced Colorectal Cancer
NCT ID: NCT02399943
Last Updated: 2022-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
14 participants
INTERVENTIONAL
2015-06-30
2022-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Trametinib and Panitumumab
Trametinib: 2 mg QD, orally, continuously.
Panitumumab: 6 mg/kg, intravenously, Q2W
Trametinib
Panitumumab
Interventions
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Trametinib
Panitumumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Principal Investigators
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Philippe Bedard, M.D.
Role: PRINCIPAL_INVESTIGATOR
Princess Margaret Cancer Centre
Locations
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Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Countries
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References
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Alshammari 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.
Other Identifiers
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MOBILITY-001
Identifier Type: -
Identifier Source: org_study_id
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