Cancer drugs which target the effects of abnormal gene changes are called 'targeted therapies'. This study, called PM.1 or CAPTUR, will include some targeted therapies that are currently available. The purpose of this study is to find out what are the effects on a patient and their cancer when they are given a targeted therapy drug that is specific to an abnormal gene change in their cancer.
Recent advances in laboratory technology have enabled the identification of changes in the genetic makeup of tumors that might be responsible for their malignant behavior such as uncontrolled growth and spread. Some of these changes can be 'druggable', i.e. there may be cancer medicines that can specifically act on the tumour's genetic abnormality. Several cancer centers and programs have initiated this type of molecular profiling across Canada, with the goal to identify 'druggable' changes in tumors to find matching therapy for patients. These include initiatives in British Columbia, Ontario and Quebec. The CAnadian Profiling and Targeted agent Utilization tRial (CAPTUR) will test the activity of a list of commercially available targeted agents in patients who have undergone tumor profiling and have 'druggable' changes identified in their cancers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
720
300mg taken twice daily
100mg administered orally once daily
* Combination Phase - 3mg/kg nivolumab administered as an intravenous infusion over 30 minutes every 3 weeks for the first 4 doses in combination with ipilmumab 1mg/kg administered intravenously over 30 minutes, followed by the single-agent phase. * Single-Agent Phase - 480mg nivolumab administered as an intravenous infusion over 30 minutes every 4 weeks.
Cross Cancer Institute
Edmonton, Alberta, Canada
RECRUITINGBCCA - Kelowna
Kelowna, British Columbia, Canada
RECRUITINGObjective response rate defined as the number of patients with complete response or partial response
over the total number of patients in a given cohort.
Time frame: 4 years
Number and severity of adverse events grade >3, or of lesser grade resulting in discontinuation, delay or reduction in dose of study drug
measured by CTCAE
Time frame: 4 years
Progression-free survival by disease-appropriate objective criteria
Time frame: 4 years
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5mg orally twice daily
500mg orally once daily
250mg orally twice daily
125mg orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days
50mg orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off
25mg infused over a 30-60 minute period once a week
150mg orally, once daily
Trastuzumab = 3-weekly dose schedule. The recommended initial loading dose is 8mg/kg administered as a 90-minute infusion followed by 3-weekly maintenance dose of 6mg/kg administered as 90-minute infusion. Pertuzumab = 840mg administered as a 60-minute intravenous infusion, followed every 3 weeks thereafter by a dose of 420mg administered over a period of 30-60 minutes.
Vemurafenib = 960 mg orally every 12 hours. Cobimetinib = 60 mg orally once daily for 21 days, followed by 7 days of rest
150mg taken orally, once daily
300mg taken orally, twice daily
BCCA - Vancouver
Vancouver, British Columbia, Canada
Kingston Health Sciences Centre
Kingston, Ontario, Canada
RECRUITINGLondon Health Sciences Centre Research Inc.
London, Ontario, Canada
RECRUITINGOttawa Hospital Research Institute
Ottawa, Ontario, Canada
RECRUITINGUniversity Health Network
Toronto, Ontario, Canada
RECRUITINGThe Jewish General Hospital
Montreal, Quebec, Canada
RECRUITINGAllan Blair Cancer Centre
Regina, Saskatchewan, Canada
RECRUITINGSaskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
RECRUITING