Targeted Therapy for Advanced Rare Cancers
(PREDiCTc Trial)
Trial Summary
What is the purpose of this trial?
This pilot clinical trial aims to assess the real world quality of life and survival of patients treated with targeted therapy that has preliminary evidence of efficacy in subjects with advanced rare cancers or cancer harbouring rare molecular aberrations. The treatment has been granted conditional or full approved by Health Canada (HC) as effective and safe. Due to the rarity of the cancer or molecular aberration the uncertainty level of the health technology assessment (HTA) by the pan Canadian Oncology Review (pCODR) was too high for consideration of funding or it was not submitted for consideration. Consequently, the goal of this study is to generate real world evidence to support HTA decision making throughout the life cycle of the product.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it requires that you are currently receiving a specific targeted therapy approved by Health Canada. You cannot participate if you've been treated with another agent or in another trial within 14 days before joining this one.
What data supports the effectiveness of the targeted therapy for advanced rare cancers?
Research shows that using targeted therapies based on specific genetic changes in rare cancers can be beneficial. In one study, 38% of patients with rare tumors had genetic changes that could be targeted with specific drugs, and some patients experienced positive responses, such as tumor shrinkage or stable disease.12345
What safety data exists for targeted therapies in humans?
The safety of targeted therapies has been evaluated in various clinical trials, including umbrella trials in precision oncology, which assess the risk and benefit of these treatments. These studies suggest that targeted therapies can be safely administered to patients with advanced cancers, although specific safety profiles may vary depending on the genetic changes within the tumors.36789
How is targeted therapy different from other treatments for advanced rare cancers?
Targeted therapy for advanced rare cancers is unique because it uses precision medicine to identify and attack specific genetic changes in cancer cells, offering a personalized treatment option where standard treatments often don't exist. This approach can lead to better outcomes by focusing on the unique genetic makeup of each patient's cancer.1231011
Research Team
Cheryl Ho, MD
Principal Investigator
BC Cancer
Eligibility Criteria
This trial is for adults over 18 with advanced rare cancers or those with uncommon molecular changes, who are expected to live at least 12 weeks. They must be on a Health Canada approved targeted therapy not covered by national funding, have stable brain metastases if present, and be physically able to undergo treatment (ECOG 0-2). Participants need functioning major organs and the ability to consent.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive targeted therapy for advanced rare cancers or cancers with rare molecular aberrations
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Targeted Therapy (Targeted Therapy)
Targeted Therapy is already approved in Canada for the following indications:
- Advanced rare cancers
- Cancer harbouring rare molecular aberrations
Find a Clinic Near You
Who Is Running the Clinical Trial?
British Columbia Cancer Agency
Lead Sponsor