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Study of drug combination in patients with advanced cancer based on genomic profiling - ProTarget Danish nationwide trial

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial studies various targeted anti-cancer treatments in patients with advanced cancer. The study uses genetic testing of tumors to match patients with specific medications that may work best for their type of cancer. The medications being tested include vemurafenib, axitinib, trastuzumab emtansine, selpercatinib, olaparib, pertuzumab, alectinib, atezolizumab, avelumab, vismodegib, pemigatinib, trastuzumab, and niraparib.

The medications are given either as tablets taken by mouth or as infusions given through a vein. The purpose is to evaluate how well these targeted treatments work against cancers that have specific genetic changes. The study will look at whether tumors shrink or stop growing after 16 weeks of treatment.

During the study, patients will receive one of the targeted treatments based on their tumor's genetic profile. Doctors will monitor how the cancer responds to treatment and watch for any side effects. Patients will have regular check-ups including physical exams and imaging scans to measure their tumors. Blood samples and additional tumor samples may be collected to study how the cancer responds to treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Your doctor will confirm that you have advanced cancer that is no longer responding to standard treatments.
Your medical records must show results from a genomic test or protein expression test of your tumor tissue.
A new tumor tissue sample may need to be collected for additional testing.
Step 2
Health screening
Your doctor will check your overall health status and organ function through blood tests.
Your cancer will be measured using imaging scans to track changes during treatment.
You must have at least one tumor that can be measured accurately.
Step 3
Treatment assignment
Based on your tumor's genetic profile, you will receive one of the approved targeted cancer medications.
The medication may be given as tablets/capsules by mouth or as an infusion into your vein.
The specific dosing schedule will depend on which medication matches your tumor's characteristics.
Step 4
Monitoring period
Your response to treatment will be evaluated after 16 weeks.
Regular checks will monitor for any side effects.
Imaging scans will measure if tumors are shrinking, staying stable, or growing.
Blood tests will continue to check your organ function.
Step 5
Long-term follow-up
The treatment may continue as long as it is helping and side effects are manageable.
Additional tumor samples or blood tests may be collected to understand how the treatment is working.
Your overall survival and time without cancer progression will be tracked.

Who can join the trial?

12 criteria

Must be at least 18 years old with confirmed advanced or spreading cancer that is no longer responding to standard treatments
Must have an ECOG performance status between 0-2 (a measure of daily living abilities and activity level)
Must have adequate organ function, including:
- Acceptable blood cell counts
- Normal liver function tests
- Adequate kidney function
- Must have cancer that can be measured by scans or physical examination (at least one tumor that is 20mm or larger with standard imaging, or 10mm or larger with CT/MRI)
- Must have results from genetic testing or protein testing of their tumor from an accredited laboratory
- Must be able to understand and sign an informed consent document
- Must have a tumor with genetic features that suggest potential benefit from the targeted therapies used in this study
- Must be able to swallow and tolerate oral medications if receiving oral treatment
- Must agree to use effective birth control methods during the study and for 4-24 months after completing treatment:
  - Women who can become pregnant must use approved contraception methods
  - Men must use barrier contraception or abstain from sexual activity

Who cannot join the trial?

16 criteria

Age under 18 years
Presence of brain metastases (cancer that has spread to the brain) that are not stable or controlled
Severe heart conditions including:
- Heart failure with symptoms
- Unstable heart rhythm disorders
- Recent heart attack (within last 6 months)
- Active, uncontrolled infections
- Known HIV infection (Human Immunodeficiency Virus)
- Active hepatitis B or C (liver infections)
- Severe kidney dysfunction requiring dialysis
- Pregnant or breastfeeding women
- Unable to take oral medications
- Participation in another clinical trial within the last 30 days
- Previous treatment with the study medication
- Known allergic reactions to similar medications
- Mental conditions that prevent understanding of the study requirements
- Life expectancy less than 3 months

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Aalborg University Hospital
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Aalborg, Denmark
Aarhus University Hospital
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Aarhus, Denmark
Herlev Hospital
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Herlev, Denmark

Trial locations

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Investigated drugs

Based on the provided trial data, I cannot extract specific medications as the source data does not contain information about individual drugs or therapies. The trial description mentions "targeted anti-cancer drugs" in general terms, but doesn't list specific medications. The trial (ProTarget) appears to be studying already EMA-approved targeted anti-cancer medications based on genomic profiling, but the specific medications are not detailed in the provided data. Without a list of specific medications from the source data, I cannot provide detailed descriptions of individual drugs or therapies involved in this clinical trial.

What is already known about the treatment

Since no specific medications are mentioned in the provided trial data, I cannot create medication-specific descriptions. The trial data only shows that it's studying targeted anti-cancer treatments based on genomic profiling, but doesn't list the actual medications. The trial aims to evaluate EMA-approved targeted anti-cancer drugs, but without specific medication names being provided, I cannot create the requested medication descriptions in the format you specified. If you could provide the specific medications being tested in this clinical trial, I would be happy to create detailed descriptions following your requested format.

Investigated diseases

Cancer - A disease characterized by abnormal cell growth where cells divide and spread uncontrollably, forming masses called tumors. Cancer can develop in almost any body tissue when genetic changes disrupt normal cell growth and division. These abnormal cells can invade nearby tissues and spread to other parts of the body through blood and lymph systems. The disease progresses when cancer cells continue to grow and potentially spread to other locations in the body through a process called metastasis. Cancer cells differ from normal cells in ways that allow them to grow out of control and become invasive. Since the trial data mentions advanced cancer with genomic variants, I should note that this refers to cancers that have specific genetic mutations affecting their growth and behavior. However, I'll maintain the simple disease description as requested, without going into treatment aspects or specific cancer types, as per the guidelines.