Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT02925234

The Drug Rediscovery Protocol (DRUP Trial)

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

1550

Participants Needed

36

Research Sites

591 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

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.

CONDITIONS

Official Title

The Drug Rediscovery Protocol (DRUP Trial)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult (over 18 years) with histologically confirmed advanced or metastatic solid tumor, multiple myeloma, or B cell non-Hodgkin lymphoma with disease progression after standard treatment or no standard treatment available
  • For primary brain tumor patients: confirmed recurrent or new brain tumor with progression after prior therapy, stable or decreasing steroid use for at least 7 days before MRI
  • ECOG performance status between 0 and 2
  • Acceptable organ function including neutrophil count ≥ 1.5 x 109/l, hemoglobin > 5.6 mmol/l, platelets > 75 x 109/l, bilirubin less than twice the upper limit, AST and ALT less than 2.5 times upper limit (or 5 times if liver metastases), and creatinine clearance ≥ 50 mL/min/1.73 m2
  • Objectively measurable disease by physical or radiographic exam according to standard criteria
  • Tumor genomic or protein expression test results available showing a potentially actionable variant using approved technologies
  • Tumor profile with potential benefit from FDA/EMA approved targeted anti-cancer drugs included in the study
  • Fresh frozen tumor biopsy obtained within 2 months before treatment start for biomarker testing, with exceptions for brain tumors and prior whole genome sequencing
  • Ability to understand and sign informed consent
  • Ability to swallow and tolerate oral medication for orally administered drugs
  • Women and men of child-bearing potential agree to use adequate contraception during and for 4 months after study treatment
Not Eligible

You will not qualify if you...

  • Ongoing toxicity greater than grade 2, except hair loss
  • Receiving other anti-cancer therapies within 2 weeks before study start, except androgen deprivation therapy for CRPC or supportive care medications started at least 1 week prior
  • Pregnant or nursing
  • Active progressive brain metastases; patients with treated brain metastases must be stable without recent seizures or neurological changes and off steroids
  • For glioblastoma patients: use of enzyme-inducing antiepileptic drugs prohibited; no radiotherapy within 3 months prior to progression diagnosis; no high-dose radiotherapy or stereotactic radiosurgery unless recurrence is confirmed
  • Significant preexisting cardiac conditions including uncontrolled angina, arrhythmias, or symptomatic heart failure
  • Left ventricular ejection fraction below 40%
  • Stroke or acute myocardial infarction within 3 months before first treatment dose
  • Other serious medical conditions or psychiatric/social situations that could interfere with study participation or compliance

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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.

CONTACT

K

K. Verkerk, MD

CONTACT

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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