Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID02925234

A Dutch National Study to Facilitate Patient Access to Commercially Available Targeted Anticancer Drugs Evaluating Potential Efficacy in Advanced Cancers With Known Molecular Profiles

Led by The Netherlands Cancer Institute · Updated on 2024-01-24

1550

Participants Needed

36

Research Sites

13 weeks

Total Duration

On this page

Sponsors

T

The Netherlands Cancer Institute

Lead Sponsor

A

Amgen

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the use of targeted anticancer drugs in patients with advanced cancer who have specific molecular changes in their tumors. This study aims to describe how well these targeted drugs work and their side effects when prescribed based on a tumor's genetic or protein profile. It focuses on patients with advanced solid tumors, multiple myeloma, or B cell non-Hodgkin lymphoma who have no standard treatment options left and have acceptable health status and organ function. Participants receive targeted cancer drugs selected from a list of approved therapies matched to their tumor's molecular profile. A molecular tumor board and study coordinators help determine the best drug choice. Before treatment, patients provide a fresh tumor biopsy for genetic analysis. The study includes many drugs, including Panitumumab, Olaparib, Dabrafenib, and several others, some given alone or in combination, according to the tumor profile. Treatment eligibility and drug-specific criteria are confirmed before starting therapy. Throughout the study, participants are monitored for tumor response, disease stability, survival, and treatment side effects. Researchers collect data on tumor changes, progression-free survival, overall survival, and how long patients remain on treatment. Next generation sequencing on tumor samples provides additional biomarker information. The study continues to follow patients for up to one year after treatment to assess outcomes and safety.

CONDITIONS

Brief Title

The Drug Rediscovery Protocol (DRUP Trial)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults over 18 years with confirmed advanced or metastatic solid tumor, multiple myeloma, or B cell non-Hodgkin lymphoma with disease progression after standard treatment or no available standard treatment
  • For brain tumor patients, confirmed recurrent or new brain tumor with progression after prior therapy and stable or decreasing steroid use
  • ECOG performance status of 0 to 2
  • Acceptable organ function including specified blood counts, liver enzymes, and kidney function
  • Measurable disease by physical or imaging exams according to standard criteria
  • Results from a tumor genomic or protein expression test showing at least one actionable molecular variant
  • Tumor profile suitable for treatment with one of the approved targeted drugs in the study
  • Fresh frozen tumor biopsy obtained within 2 months before treatment for biomarker testing, with some exceptions for brain tumor patients and prior tissue samples
  • Ability and willingness to sign informed consent
  • Ability to swallow and tolerate oral medication for oral drugs
  • Agreement to use contraception during and for four months after study treatment for men and women of child-bearing potential
Not Eligible

You will not qualify if you...

  • Ongoing treatment toxicity greater than grade 2 except hair loss
  • Receiving other anti-cancer treatments without required washout, except approved exceptions like androgen deprivation therapy for CRPC
  • Pregnancy or nursing
  • Active progressive brain metastases or unstable neurological status
  • For glioblastoma patients, restrictions on certain anti-convulsant drugs and recent radiotherapy
  • Significant heart conditions including uncontrolled angina, arrhythmias, or heart failure
  • Left ventricular ejection fraction below 40%
  • Stroke or heart attack within 3 months before starting treatment
  • Any other medical condition that could interfere with study participation or compliance as judged by the physician
  • Drug-specific inclusion and exclusion criteria may also apply and take precedence

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 6 months after treatment initiation (estimated average)

Participants receive targeted anticancer drugs matched to their tumor's molecular profile. Treatment continues until disease progression or discontinuation.

Regular visits during treatment as per protocol

Follow-up

Duration - Up to 1 year after study completion

Participants are monitored for progression-free survival and overall survival outcomes after completing treatment.

Periodic follow-up visits for up to 1 year

Trial Site Locations

Total: 36 locations

1

Noordwest ziekenhuisgroep Alkmaar (NWZ)

Alkmaar, Netherlands

Actively Recruiting

2

Ziekenhuisgroep Twente

Almelo, Netherlands

Actively Recruiting

3

Meander medisch centrum

Amersfoort, Netherlands, 3818 ES

Actively Recruiting

4

Netherlands Cancer Institute

Amsterdam, Netherlands, 1066CX

Actively Recruiting

5

Amsterdam UMC, locatie VUmc

Amsterdam, Netherlands, 1081 HV

Actively Recruiting

6

Amsterdam UMC, locatie AMC

Amsterdam, Netherlands, 1105AZ

Active, Not Recruiting

7

Onze Lieve Vrouwe Gasthuis (OLVG)

Amsterdam, Netherlands

Actively Recruiting

8

Gelre ziekenhuizen

Apeldoorn, Netherlands

Actively Recruiting

9

Rijnstate ziekenhuis

Arnhem, Netherlands

Actively Recruiting

10

Amphia Ziekenhuis

Breda, Netherlands

Actively Recruiting

11

Reiner de Graaf Gasthuis

Delft, Netherlands

Actively Recruiting

12

Deventer ziekenhuis

Deventer, Netherlands

Actively Recruiting

13

Nij Smellinghe Ziekenhuis

Drachten, Netherlands

Actively Recruiting

14

Ziekenhuis Gelderse Vallei

Ede, Netherlands

Actively Recruiting

15

Maxima Medisch Centrum

Eindhoven, Netherlands, 5631 BM

Actively Recruiting

16

Zuyderland medisch centrum

Geleen, Netherlands, 6162 BG

Actively Recruiting

17

Rivas zorggroep

Gorinchem, Netherlands

Actively Recruiting

18

Martini ziekenhuis

Groningen, Netherlands

Actively Recruiting

19

University Medical Center Groningen

Groningen, Netherlands

Actively Recruiting

20

Spaarne gasthuis

Haarlem, Netherlands

Actively Recruiting

21

Tergooi MC

Hilversum, Netherlands

Not Yet Recruiting

22

Treant zorggroep

Hoogeveen, Netherlands

Actively Recruiting

23

Medisch Centrum Leeuwaarden

Leeuwarden, Netherlands

Actively Recruiting

24

Leiden University Medical Center

Leiden, Netherlands

Actively Recruiting

25

Maastricht University Medical Center

Maastricht, Netherlands

Actively Recruiting

26

St. Antonius ziekenhuis

Nieuwegein, Netherlands

Actively Recruiting

27

Radboud umc

Nijmegen, Netherlands, 6225GA

Actively Recruiting

28

Bravis ziekenhuis

Roosendaal, Netherlands

Actively Recruiting

29

St. Fransicus Gasthuis

Rotterdam, Netherlands, 3045 PM

Actively Recruiting

30

Erasmus MC

Rotterdam, Netherlands

Actively Recruiting

31

Haaglanden medisch centrum

The Hague, Netherlands

Actively Recruiting

32

Haga ziekenhuis

The Hague, Netherlands

Actively Recruiting

33

Elisabeth-TweeSteden Ziekenhuis

Tilburg, Netherlands, 5022 GC

Actively Recruiting

34

University Medical Center Utrecht

Utrecht, Netherlands, 3584CX

Actively Recruiting

35

VieCuri medisch centrum

Venlo, Netherlands

Actively Recruiting

36

Isala klinieken

Zwolle, Netherlands

Actively Recruiting

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Research Team

E

E.E. Voest, prof.

K

K. Verkerk, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

37

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Published Research Related To This Trial

Efficacy of Pembrolizumab and Biomarker Analysis in Patients with WGS-Based Intermediate to High Tumor Mutational Load: Results from the Drug Rediscovery Protocol.

Birgit S Geurts, Laurien J Zeverijn, Lindsay V M Leek...

https://pubmed.ncbi.nlm.nih.gov/38630551

Limited clinical activity of palbociclib and ribociclib monotherapy in advanced cancers with cyclin D-CDK4/6 pathway alterations in the Dutch DRUP and Australian MoST trials.

Laurien J Zeverijn, Eleonora J Looze, Subotheni Thavaneswaran...

https://pubmed.ncbi.nlm.nih.gov/37424386

Efficacy, safety and biomarker analysis of durvalumab in patients with mismatch-repair deficient or microsatellite instability-high solid tumours.

Birgit S Geurts, Thomas W Battaglia, J Maxime van Berge Henegouwen...

https://pubmed.ncbi.nlm.nih.gov/36870947

Efficacy and toxicity of vemurafenib and cobimetinib in relation to plasma concentrations, after administration via feeding tube in patients with BRAF-mutated thyroid cancer: a case series and review of literature.

J M van Berge Henegouwen, H van der Wijngaart, L J Zeverijn...

https://pubmed.ncbi.nlm.nih.gov/35598186

Comprehensive Molecular Characterization Reveals Genomic and Transcriptomic Subtypes of Metastatic Urothelial Carcinoma.

J Alberto Nakauma-González, Maud Rijnders, Job van Riet...

https://pubmed.ncbi.nlm.nih.gov/35086719