NCT03297606

Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR)

Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR): A Phase II Basket Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 720 (estimated)
• Sponsor: Canadian Cancer Trials Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lymphoma, Non-Hodgkin
• Multiple Myeloma
• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	Olaparib	300mg taken twice daily
DRUG	Dasatinib	100mg administered orally once daily
DRUG	Nivolumab plus Ipilimumab	* 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.
DRUG	Axitinib	5mg orally twice daily
DRUG	Bosutinib	500mg orally once daily
DRUG	Crizotinib	250mg orally twice daily
DRUG	Palbociclib	125mg orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days
DRUG	Sunitinib	50mg orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off
DRUG	Temsirolimus	25mg infused over a 30-60 minute period once a week
DRUG	Erlotinib	150mg orally, once daily
DRUG	Trastuzumab plus Pertuzumab	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.
DRUG	Vemurafenib plus Cobimetinib	Vemurafenib = 960 mg orally every 12 hours. Cobimetinib = 60 mg orally once daily for 21 days, followed by 7 days of rest
DRUG	Vismodegib	150mg taken orally, once daily
DRUG	Tucatinib	300mg taken orally, twice daily

Timeline

• Start date: 2018-03-23
• Primary completion: 2026-12-31
• Completion: 2027-01-31
• First posted: 2017-09-29
• Last updated: 2026-03-27

Locations

10 sites across 1 country: Canada