The Drug Rediscovery Protocol (DRUP Trial)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Netherlands Cancer Institute

About this trial

This is a prospective, non-randomized clinical trial that aims to describe the efficacy and toxicity of commercially available, targeted anticancer drugs\* prescribed for treatment of patients with advanced cancer with a potentially actionable variant as revealed by a genomic or protein expression test. The study also aims to simplify patient access to approved targeted therapies that are contributed to the program by collaborating pharmaceutical companies and to perform next generation sequencing on tumor biopsies for biomarker analyses. Eligible patients have an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma for which standard treatment options are no longer available and acceptable performance status and organ function. A genomic or protein expression test must have been performed on the tumor and the results must identify at least one potentially actionable molecular variant as defined in the protocol. Results from the molecular profiling test will be used to determine an appropriate drug(s) from among those available in the protocol. The choice of drug will be supported by a list of potential profiles, a molecular tumor board, a knowledge library and by study coordinators for review and approval of the match. The protocol-specified treatment will be administered to the patient once any drug-specific eligibility criteria are confirmed and a fresh pre-treatment biopsy is performed for future genetic studies. All patients who receive treatment with a drug available in the protocol will be followed for standard efficacy outcomes including tumor response, progression-free and overall survival as well as duration of treatment. In addition, treatment related toxicity will be evaluated.

Eligibility criteria

Qualifiers

Adult (age >18 years) patient with a histologically-proven locally advanced or metastatic solid tumor, multiple myeloma or B cell non-Hodgkin lymphomawith symptomatic disease progression or progression according to RECIST-criteria after standard anti-cancer treatment or for whom no such treatment is available or indicated.

ECOG performance status 0-2

Patients must have acceptable organ function as defined below. However, specific inclusion/

Disqualifiers

Absolute neutrophil count ≥ 1.5 x 109/l

Hemoglobin > 5.6 mmol/l

Platelets > 75 x 109/l

Total bilirubin < 2 x ULN

Trial design

Treatments tested in this trial

  • Panitumumab
  • Olaparib
  • Dabrafenib
  • Nilotinib
  • Trametinib
  • Erlotinib
  • Trastuzumab and Pertuzumab (combination treatment)
  • Vemurafenib and Cobimetinib (combination treatment)
  • Vismodegib
  • Regorafenib
  • Nivolumab
  • Afatinib
  • Dabrafenib and trametinib
  • Ribociclib
  • Lenvatinib
  • Pembrolizumab
  • Durvalumab
  • Rucaparib
  • Axitinib
  • Palbociclib
  • Crizotinib
  • Sunitinib
  • Cabozantinib
  • Abemaciclib
  • Alectinib
  • Atezolizumab and Bevacizumab
  • Ipilimumab and nivolumab
  • Entrectinib
  • Talazoparib
  • Dacomitinib
  • Lorlatinib
  • Erdafitinib
  • Alpelisib
  • Niraparib
  • Pemigatinib
  • Selpercatinib
  • Tepotinib

Treatment groups

1,550 Participants
are divided into 37 treatment groups

37

Treatment groups

See each treatment group below.

Sponsors and collaborators

The Netherlands Cancer Institute

Lead sponsor

Amgen

Collaborator

AstraZeneca

Collaborator

Bayer

Collaborator

Bristol-Myers Squibb

Collaborator

Novartis

Collaborator

Roche Pharma AG

Collaborator

Merck Sharp & Dohme LLC

Collaborator

Boehringer Ingelheim

Collaborator

Ipsen

Collaborator

Eisai Inc.

Collaborator

Pfizer

Collaborator

Clovis Oncology - Pharma and

Collaborator

Eli Lilly and Company

Collaborator

Janssen, LP

Collaborator

GlaxoSmithKline

Collaborator

Incyte Corporation

Collaborator

Dutch Cancer Society

Collaborator

Stelvio for Life

Collaborator