ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling
Status:
Recruiting
Trial end date:
2025-04-30
Target enrollment:
Participant gender:
Summary
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.