Vemurafenib and Panitumumab Combination Therapy in Patients With BRAF V600E Mutated Metastatic Colorectal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01791309|
Recruitment Status : Completed
First Posted : February 13, 2013
Last Update Posted : January 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colorectal Cancer||Drug: combination panitumumab and vemurafenib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Vemurafenib and Panitumumab Combination Therapy in Patients With BRAF V600E Mutated Metastatic Colorectal Cancer|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
Experimental: combination panitumumab and vemurafenib
This will be a pilot study of the combination panitumumab and vemurafenib in patients with metastatic colorectal cancer with a BRAF V600E mutation. Patients participating in this study must have BRAF V600E mutated metastatic colorectal cancer and not previously received treatment with an anti-EGFR targeting antibody (cetuximab or panitumumab).
Drug: combination panitumumab and vemurafenib
Treatment will consist of panitumumab 6mg/kg IV every 14 days and vemurafenib 960mg orally twice daily. In patients who initially respond to treatment and later progress, a voluntary biopsy will be requested at the time of relapse to study mechanisms of acquired resistance. This biopsy should consist of at least one frozen core specimen. Every effort will be made to obtain this biopsy within 30 days of discontinuation of treatment and before the initiation of any new tumor-directed therapies.
- objective response rate (ORR) [ Time Frame: 6 months ]Overall response will be estimated based on best response to this combination in six months of treatment.
- progression-free survival (PFS) [ Time Frame: 2 years ]Progression free survival (PFS) is defined as the period elapsing between the date of initiation of therapy and the date of either disease progression or date of death, whichever is earlier.
- overall survival (OS) [ Time Frame: 2 years ]OS is defined as the interval between the time of initiation of therapy and the date of death from any cause. Patients who are alive at the time of study completion will be censored at the time the patient was last known to be alive.
- safety, tolerability, and adverse event profile [ Time Frame: 1 year ]The safety endpoints will include all types of adverse experiences, laboratory safety measurements, ECOG performance scale status, and vital signs. Adverse experiences will be graded and recorded throughout the study according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0.
- efficacy [ Time Frame: 2 years ]using pre- and post-vemurafenib tumor biopsies obtained from the first 10 patients participating in this trial.
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): NCT01791309
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Rona Yaeger, MD||Memorial Sloan Kettering Cancer Center|