30 Participants Needed

Targeted Therapy for Advanced Rare Cancers

(PREDiCTc Trial)

SP
Overseen BySamantha Pollard, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: British Columbia Cancer Agency
Must be taking: Targeted therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a targeted therapy designed to address specific genetic features of cancer cells in individuals with advanced rare cancers or cancers with unusual genetic traits. The goal is to assess how this treatment impacts quality of life and survival in real-world settings. The trial seeks participants living with one of these rare cancers who are already receiving a targeted therapy approved by Health Canada but not yet funded nationwide. Participants should be in good general health and able to complete quality-of-life surveys. The study aims to gather evidence to inform decisions about making this treatment more widely available. As an unphased trial, it offers a unique opportunity to contribute to research that could expand access to promising treatments.

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 prior data suggests that this targeted therapy is safe for patients with advanced rare cancers?

Research has shown that targeted therapy, which focuses on specific parts of cancer cells, often produces different side effects than traditional chemotherapy. Some targeted therapies may cause fewer side effects by attacking cancer cells while sparing normal cells.

In some studies, targeted therapies have generally been well-tolerated, meaning most people do not experience severe side effects. However, side effects can still occur and vary based on the drug and the individual. Common side effects might include fatigue, diarrhea, and skin changes.

Health Canada has approved the treatment in this trial, indicating it has passed safety checks for other uses. This approval suggests the therapy is considered safe, but monitoring participants for any side effects during the trial remains important.12345

Why are researchers excited about this trial?

Researchers are excited about targeted therapy for advanced rare cancers because it offers a personalized approach to treatment. Unlike standard chemotherapy or radiation, which can affect both healthy and cancerous cells, targeted therapies are designed to home in on specific molecules or pathways involved in cancer growth. This precision can potentially lead to fewer side effects and improved effectiveness. By directly interfering with the cancer's unique biology, targeted therapy provides hope for better outcomes in cancers that currently have limited treatment options.

What evidence suggests that this targeted therapy is effective for advanced rare cancers?

Studies have shown that targeted therapies, which address the specific genetic causes of cancer, can improve outcomes for patients with rare cancers. Research indicates that these treatments are particularly effective in advanced rare cancers by tailoring approaches to the unique genetic makeup of each tumor. In this trial, participants will receive targeted therapy, which has demonstrated better results in conditions like non-small cell lung cancer, melanoma, and kidney cancer. Evidence suggests that by attacking the cancer at its genetic source, these therapies can slow the disease and potentially extend patients' lives. With Health Canada's approval, these treatments are considered both effective and safe for certain types of cancer.34678

Who Is on the Research Team?

Dr. Cheryl Ho - Division of Medical ...

Cheryl Ho, MD

Principal Investigator

BC Cancer

Are You a Good Fit for This Trial?

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

You are expected to live for at least 12 more weeks.
I am able to care for myself and move around.
I have brain metastases that are either symptom-free or treated.
See 3 more

Exclusion Criteria

My doctor thinks I am not fit for this treatment plan.
Inability to complete quality of life questionnaires
I haven't taken any experimental drugs or joined another clinical trial in the last 14 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive targeted therapy for advanced rare cancers or cancers with rare molecular aberrations

12 weeks
Regular interval radiographic imaging and collection of patient-reported outcomes

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Targeted Therapy
Trial Overview The PREDiCTc trial is evaluating the quality of life and survival rates in patients using targeted therapies for rare cancers. These treatments have some evidence of working but aren't widely funded due to their novelty. The study uses CT imaging and Quality of Life (QOL) assessments as tools.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Targeted therapyExperimental Treatment2 Interventions

Targeted Therapy is already approved in Canada, European Union, United States for the following indications:

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Approved in Canada as Targeted Therapy for:
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Approved in European Union as Targeted Therapy for:
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Approved in United States as Targeted Therapy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

British Columbia Cancer Agency

Lead Sponsor

Trials
181
Recruited
95,900+

Published Research Related to This Trial

The MASTER precision oncology network shows that using whole-genome/exome and RNA sequencing can lead to targeted treatments for patients with advanced rare cancers, which are often poorly understood.
This approach has been beneficial for a significant number of patients, highlighting the potential for future clinical trials to further explore these personalized treatment options.
Interdisciplinary team science to understand and intercept rare cancers.Fröhling, S.[2022]
The TAPUR Study is a large-scale clinical trial involving over 1000 participants with advanced cancer, aiming to evaluate the effectiveness of FDA-approved drugs matched to specific genomic targets, showing promising preliminary activity in 12 out of 16 cohorts.
The study's primary goal is to assess the objective response or stable disease for at least 16 weeks, while also monitoring safety and overall survival, indicating a structured approach to personalized cancer treatment.
Rationale and Design of the Targeted Agent and Profiling Utilization Registry (TAPUR) Study.Mangat, PK., Halabi, S., Bruinooge, SS., et al.[2022]
In a study of 1,310 patients with rare cancers, comprehensive molecular analysis using whole-genome/exome and RNA sequencing led to evidence-based management recommendations in 88% of cases, highlighting its potential to improve treatment strategies.
Patients who received recommended therapies based on molecular profiling showed significantly better outcomes, with overall response rates of 23.9% and disease control rates of 55.3%, indicating that molecular stratification can enhance treatment efficacy in this underserved population.
Comprehensive Genomic and Transcriptomic Analysis for Guiding Therapeutic Decisions in Patients with Rare Cancers.Horak, P., Heining, C., Kreutzfeldt, S., et al.[2022]

Citations

Advances in personalized medicine: translating genomic ...... cancers where targeted therapies may improve outcomes. For certain ... Advanced Cancer Therapy (IMPACT): An MD Anderson Precision Medicine Study.
Designing Clinical Trials for Patients With Rare CancersBy focusing on the genetic drivers of cancer, these treatments transcend traditional boundaries that benefit rare cancers more than ever, ...
Study Details | NCT06855134 | Treatment Guided by ...... advanced rare cancers. This approach has demonstrated significant ... For patients undergoing active tumor therapy before randomization (bridging ...
Exploring treatment options in cancer: tumor ...The use of these drugs has been associated with improved outcomes in non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma (RCC), ...
Review of Precision Cancer Medicine: Evolution of the ...Additionally, under the pressure of targeted treatments, tumor ... Advanced Cancers: Results of the MOSCATO 01 Trial. Cancer Discov 2017;7:586 ...
Criteria for assessing evidence for biomarker-targeted ...Advances in targeted therapy development and tumor sequencing technology are reclassifying cancers into smaller biomarker-defined diseases.
Genomically matched therapy in advanced solid tumors... targeted therapy was generally preferred, provided that safety data were available. All treatments were administered according to the ...
Targeted Drug Therapy Side EffectsTargeted therapy has different side effects than standard or traditional chemotherapy (chemo). Some targeted therapies have very few side effects.
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