The Drug Rediscovery Protocol (DRUP trial)
A Dutch National Study on behalf of the Center for Personalized Cancer Treatment (CPCT) to Facilitate Patient Access to Commercially Available, Targeted Anti-cancer Drugs to determine the Potential Efficacy in Treatment of Advanced Cancers with a Known Molecular Profile.
Patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma for which standard treatment options are no longer available.
Cancer cells have their own characteristics that distinguish them from healthy cells. These characteristics can be a target for anti-cancer therapy. This type of therapy, aimed at specific cancer-cell characteristics, is known as ‘targeted therapy’. The number of available targeted anti-cancer drugs is continuously increasing. Each drug targets one or more specific cancer-cell characteristics, and each drug can only be prescribed when this cancer-cell characteristic is present.
The efficacy of targeted anti-cancer drugs is mainly studied within the tumor types that most frequently harbor the aberration that is being targeted by the drug. This can lead to approval and reimbursement of the drug, for patients with the tumor type and tumor cell-characteristics the drug has been tested in. Such tumor cell-characteristic can sometimes be found in other tumor types as well though. In theory, the targeted drug in question could also be effective against these other tumor types. In daily practice however, patients with other tumor types don’t have access to these drugs since the drugs have not been tested and are therefore not reimbursed for their tumor types. This limits the access to these drugs as well as the knowledge on their efficacy outside of their approved indication.
Altogether, there is an unmet need for broader access to and knowledge on these drugs. This study will meet both needs, by facilitating tumor cell-characteristic-based patient access to approved targeted therapy, whilst systematically mapping the efficacy and toxicity of these drugs across tumor types.
In this study patients will be treated with targeted anti-cancer drugs which have been matched to the patient’s tumor cell-characteristics. These drugs have been approved and are commercially available within the Netherlands, but are normally used for treatment of other tumor types. Several Dutch hospitals will participate.
For every potential study participant, we first check whether he or she meets all criteria for safe treatment with the drug that has been matched to his or her tumor cell-characteristics. If the patients meets all these criteria, a pre-treatment blood (10 ml) and tumor biopsy sample are obtained. These samples are used to read out the genetic characteristics (the DNA profile) of the tumor cells. This is done by the Hartwig Medical Foundation (www.hartwigmedicalfoundation.nl). HMF works with a new technique, Next Generation DNA sequencing, with which it is now possible to read out the complete DNA profile of a tumor. By studying these DNA profiles and associating them with treatment outcomes we aim to improve our understanding of differences in sensitivity to anti-cancer treatment.
After the tumor biopsy and blood sample have been obtained, study treatment can be initiated. The actual treatment schedule is determined by the study drug which has been chosen based on one’s tumor cell-characteristics. The effects of the study drug will be regularly checked during treatment. In principle, patients can continue study treatment as long as clinical benefit is observed or until unacceptable toxicity occurs.
The Drug Rediscovery Protocol (DRUP trial) is officially open for inclusion. For more information on the trial, please contact your own oncologist, an oncologist in one of the participating hospitals, or the Principle Investigators of this trial: prof. Henk Verheul, prof. Hans Gelderblom and prof. Emile Voest.