Actively Recruiting
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
Eligibility Criteria
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
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
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
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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