A Trial of Trametinib and Panitumumab in RAS/RAF Wild Type Advanced Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT02399943|
Recruitment Status : Active, not recruiting
First Posted : March 26, 2015
Last Update Posted : December 5, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer KRAS Wildtype NRAS Wildtype BRAF Wildtype||Drug: Trametinib Drug: Panitumumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Molecular Basket Trial In Multiple Malignancies With Common Target Pathway Aberrancies|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Trametinib and Panitumumab
Trametinib: 2 mg QD, orally, continuously.
Panitumumab: 6 mg/kg, intravenously, Q2W
Other Name: MEKINIST
Other Name: VECTIBIX
- Percentage of patients who experience complete response, partial response, or stable disease [ Time Frame: 24 weeks ]by RECIST 1.1 criteria
- Frequency and proportion of patients who experience side effects. [ Time Frame: 3 years ]by system organ class and preferred term
- Proportion of subjects achieving either a complete or partial tumor response [ Time Frame: 3 years ]by RECIST 1.1 criteria
- Time period from the first dose of Trametinib and Panitumumab to the first date in which progression or death is observed [ Time Frame: 3 years ]
- Date of first confirmed response to the first date in which progression is observed [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02399943
|Princess Margaret Cancer Centre|
|Toronto, Ontario, Canada|
|Principal Investigator:||Philippe Bedard, M.D.||Princess Margaret Cancer Centre|