Actively Recruiting
ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling
Led by Ulrik Lassen · Updated on 2025-07-25
300
Participants Needed
7
Research Sites
505 weeks
Total Duration
On this page
Sponsors
U
Ulrik Lassen
Lead Sponsor
R
Roche Pharma AG
Collaborating Sponsor
AI-Summary
What this Trial Is About
The ProTarget study is a phase II, prospective, non-randomized clinical trial with the primary purpose of investigating the safety and efficacy of commercially available cancer drugs that target specific changes in cancer cell DNA to treat patients with advanced cancer. The primary endpoint is anti-tumor activity or stable disease documented after 16 weeks of experimental drug treatment. The drugs used in the trial have been approved by EMA/FDA for the treatment of certain cancers. Choice of drug is based on whether the patient's cancer cells contain precisely the DNA change (i) targeted by the EMA/FDA-approved drug or (ii) related to sensitivity to the EMA/FDA-approved drug. The trial drug is thus not approved by the EMA/FDA or in Denmark for the treatment of the patient's cancer - it is so-called "off-label use". The secondary purposes are: * To detect side effects in patients treated with commercially available targeted cancer drugs. * Performing biomarker analyzes, including (but not limited to) whole-genome analysis (WGS) on a fresh tumor tissue sample (biopsy) at baseline and progression. * To investigate mechanisms of resistance using recurrent / serial fresh tumor biopsies for WGS and so-called liquid biopsies, which are blood samples in which the cancer cell DNA is analyzed. The secondary endpoints include response duration, progression-free survival, and overall survival.
CONDITIONS
Official Title
ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older with histologically confirmed locally advanced or metastatic cancer no longer benefiting from standard treatment or with no standard treatment available
- ECOG performance status of 0 to 2
- Acceptable organ function including neutrophil count ≥ 1500/µl, hemoglobin > 5.6 mmol/l, platelets > 75,000/µl, bilirubin < 1.5 times normal, liver enzymes < 2.5 times normal (or < 5 times if liver metastases), and creatinine clearance ≥ 50 mL/min/1.73 m2
- Measurable or evaluable disease by physical or radiographic exam with at least one lesion ≥ 20 mm by conventional methods or ≥ 10 mm by CT/MRI or superficial lesion measurable by calipers; lymph nodes must be ≥ 15 mm in short axis
- Available results from a genomic or immunohistochemistry test performed in an accredited laboratory showing at least one actionable genomic variant or protein overexpression
- Ability to understand and willing to sign informed consent
- Tumor genomic profile suitable for treatment with one of the approved targeted therapies in the study
- Ability to swallow and tolerate oral medication without malabsorption syndrome (for oral drugs)
- Agreement to use highly effective contraception during and after study participation as specified
You will not qualify if you...
- Ongoing toxicity greater than CTCAE grade 2 from prior anti-cancer treatment completed within 4 weeks, except peripheral neuropathy less than grade 3
- Previous treatment with the selected study drug for the same cancer
- Tumor genomic variant known to cause resistance to a study drug excludes use of that drug
- Receiving other anti-cancer therapies except specified supportive care or ongoing castration therapy started at least 1 month prior
- Pregnant or nursing females and patients refusing effective contraception
- Progressive brain metastases or unstable neurological status; special restrictions for glioblastoma patients including antiepileptic drug use and recent radiotherapy
- Preexisting uncontrolled cardiac conditions or left ventricular ejection fraction below 40%
- Recent stroke or heart attack within 4 months
- Acute gastrointestinal bleeding within 1 month
- Other significant medical conditions that may interfere with study participation
- Not meeting drug-specific eligibility requirements
- Disease not measurable or assessable by imaging or physical exam
- Known allergy or hypersensitivity to the study drug or its ingredients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Aalborg University Hospital
Aalborg, Aalborg, Denmark, 9000
Not Yet Recruiting
2
Aarhus University Hospital
Aarhus, Aarhus, Denmark, 8200
Not Yet Recruiting
3
Rigshospitalet
Copenhagen, Copenhagen, Denmark, 2100
Actively Recruiting
4
Herlev Hospital
Herlev, Herlev, Denmark, 2730
Not Yet Recruiting
5
Odense University Hospital
Odense, Odense, Denmark, 5000
Not Yet Recruiting
6
Zealand University Hospital
Roskilde, Roskilde, Denmark, 4000
Not Yet Recruiting
7
Vejle Sygehus
Vejle, Vejle, Denmark, 7100
Not Yet Recruiting
Research Team
U
Ulrik Lassen, Prof.
CONTACT
K
Kristoffer S Rohrberg, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
10
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