DRUP STUDIE

DRUP INTERNATIONAL

DRUG ACCESS PROTOCOL

General information DRUG Access

The DRUG Access Protocol is a national protocol to facilitate access to new targeted anti-cancer drugs that are not yet eligible for health insurance coverage in the Netherlands while additional data is pending, while simultaneously allowing for the collection of data on the efficacy and safety of these anti-cancer drugs.

PURPOSE & TARGET AUDIENCE

The study aims, primarily, to provide cancer patients access to promising drugs that have already been studied in terms of their effects on their specific tumor types across several research phases, and that have shown positive results, but that have not yet been made available on the Dutch market for a variety of reasons. Giving patients access to these new drugs will allow for the simultaneous collection of data on the efficacy and safety of the treatment. This additional data can be beneficial for the eventual admission of the drug to the Dutch market.

Patients with cancer for whom no sufficient treatment options are available within the Dutch health care system and who qualify, based on their tumor type or the specific characteristics in the tumor DNA, for treatment with a drug that is available within the DRUG Access Protocol.

METHODS

In this protocol, patients with solid tumors and a previously established potentially ‘actionable’ tumor profiles (histological or molecular) are treated with a drug that is not yet available to patients in the Netherlands but that is currently in the process of registration. Included in this protocol are drugs for which FDA/EMA registration has been requested, or drugs that are awaiting a positive decision in terms of health care coverage by the Dutch government. Data from these patients will be systematically collected as soon as the patient’s practicing physician reports them to the study team, and grouped together with data from other patients who are being treated with the same unauthorized drug by their practicing physicians. The donation of a pre-treatment tumor biopsy is optional; this can be used in a biomarker analysis at a later time. If the patient agrees to participate in the study, this will be followed up with standard toxicity and efficacy outcomes, including tumor response, progression, free and overall survival, and duration of study treatment.

PATIENT INFORMATION

This trial uses targeted anti-cancer drugs to treat patients with cancer based on their cancer cell characteristics. These drugs are technically not yet approved, but they have been researched extensively. Many hospitals in the Netherlands take part in this trial.

If a patient would like to participate in this trial, their practicing physician will look into  whether the patient qualifies for a safe treatment with the specific drug by means of a physical and additional examination.

If a patient meets the requirements, the treatment can start. The exact treatment will depend on the type of drug selected, based on the tumor cell characteristics. During treatment, we regularly check its effects. Participating patients can continue taking the trial drugs as long as they benefit from them.

THE FOLLOWING HOSPITALS HAVE BEEN DESIGNATED FOR CEMIPLIMAB USE

Netherlands Cancer Institute | Erasmus Medical Center | Maastricht University Medical Center
Radboud Universitair Medisch Centrum | Universitair Medical Center Groningen

Centers participating in the DRUG Access Protocol will be assigned per drug by the NVMO

INFORMATION

For more information about the trial and/or potential future participation, please contact your oncologist and/or an oncologist at one of the participating centers. Or contact the trial team at drugaccess@nki.nl

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THE TEAM

Coordinating PI’s

Emile Voest, MD, PhD – Antoni van Leeuwenhoek Ziekenhuis. Haiko Bloemendal, MD, PhD – Radboud UMC, Nijmegen

Egbert Smit, MD, PhD – Antoni van Leeuwenhoek Ziekenhuis

Coordinating sub-investigators

Laurien Zeverijn, MD – Antoni van Leeuwenhoek Ziekenhuis. Gijs de Wit, MD – Antoni van Leeuwenhoek Ziekenhuis

Birgit Geurts, MD – Antoni van Leeuwenhoek Ziekenhuis

Trial manager

Lena Bilet, PhD – Antoni van Leeuwenhoek Ziekenhuis