The Drug Rediscovery Protocol (DRUP Trial)

NCT02925234 | Recruiting Phase 2 DMC

• 1 other identifier: M15DRU
• Study Type: interventional
• Target: 1,550
• Locations: 1 country
• Sites: 36

Brief Summary

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

Cancer; Tumors; Neoplasm; Neoplasia

Keywords

Molecular tumor profile; Multidisciplinary tumor board; Antitumor drugs; Molecular Targeted Therapy; Drug Repositioning; Off-Label Use; Sequence Analysis, DNA

Outcome Measures

Primary Outcomes (4)

• Percentage of patients that are treated based on their molecular tumor profile

  Primary outcome measure 1 is the percentage of submitted patients, that can be treated based on their molecular tumor profile within the context of this protocol.

  6 months after treatment initiation (estimated average)

• Objective tumor response

  Primary outcome measure 2 is the proportion of study participants with an objective tumor response upon study treatment..

  6 months after treatment initiation (estimated average)

• Stable disease

  Primary outcome measure 3 is the proportion of study participants that has stable disease (SD) during study treatment.

  6 months after treatment initiation (estimated average)

• Treatment-related grade≥3 and serious adverse events

  Primary outcome measure 4 is the proportion of patients that experience treatment-related grade≥3 and /or serious adverse events.

  6 months after treatment initiation (estimated average)

Secondary Outcomes (3)

• Progression-free survival

  Up to 1 year after study completion

• Overall survival

  Up to 1 year after study completion

• Duration of treatment on study (time on drug)

  6 months after treatment initiation (estimated average)

Other Outcomes (1)

• Concordance between pre-treatment and historic mutational tumor profile

  2 months after treatment initiation (estimated average)

Study Arms (37)

Panitumumab

EXPERIMENTAL

Panitumumab for patients with a molecular tumor profile that can potentially be targeted by Panitumumab.

Drug: Panitumumab

Olaparib

EXPERIMENTAL

Olaparib for patients with a molecular tumor profile that can potentially be targeted by Olaparib.

Drug: Olaparib

Dabrafenib

EXPERIMENTAL

Dabrafenib for patients with a molecular tumor profile that can potentially be targeted by Dabrafenib.

Drug: Dabrafenib

Nilotinib

EXPERIMENTAL

Nilotinib for patients with a molecular tumor profile that can potentially be targeted by nilotinib.

Drug: Nilotinib

Trametinib

EXPERIMENTAL

Trametinib for patients with a molecular tumor profile that can potentially be targeted by trametinib.

Drug: Trametinib

Erlotinib

EXPERIMENTAL

Erlotinib for patients with a molecular tumor profile that can potentially be targeted by erlotinib.

Drug: Erlotinib

Trastuzumab & Pertuzumab (combination)

EXPERIMENTAL

Trastuzumab and Pertuzumab (combination treatment) for patients with a molecular tumor profile that can potentially be targeted by Trastuzumab and Pertuzumab.

Drug: Trastuzumab and Pertuzumab (combination treatment)

Vemurafenib & Cobimetinib (combination)

EXPERIMENTAL

Vemurafenib and Cobimetinib (combination treatment) for patients with a molecular tumor profile that can potentially be targeted by Vemurafenib and Cobimetinib.

Drug: Vemurafenib and Cobimetinib (combination treatment)

Vismodegib

EXPERIMENTAL

Vismodegib for patients with a molecular tumor profile that can potentially be targeted by vismodegib.

Drug: Vismodegib

Regorafenib

EXPERIMENTAL

Regorafenib for patients with a molecular tumor profile that can potentially be targeted by regorafenib.

Drug: Regorafenib

Nivolumab

EXPERIMENTAL

Nivolumab for patients with a molecular tumor profile that can potentially be targeted by nivolumab.

Drug: Nivolumab

Afatinib

EXPERIMENTAL

Afatinib for patients with a molecular tumor profile that can potentially be targeted by Afatinib.

Drug: Afatinib

Dabrafenib & trametinib (combination)

EXPERIMENTAL

Dabrafenib and trametinib (combination treatment) for patients with a molecular tumor profile that can potentially be targeted by Dabrafenib and trametinib.

Drug: Dabrafenib and trametinib

Ribociclib

EXPERIMENTAL

Ribociclib for patients with a molecular tumor profile that can potentially be targeted by Ribociclib.

Drug: Ribociclib

Lenvatinib

EXPERIMENTAL

Lenvatinib for patients with a molecular tumor profile that can potentially be targeted by Lenvatinib.

Drug: Lenvatinib

Pembrolizumab

EXPERIMENTAL

Pembrolizumab for patients with a molecular tumor profile that can potentially be targeted by Pembrolizumab.

Drug: Pembrolizumab

Durvalumab

EXPERIMENTAL

Durvalumab for patients with a molecular tumor profile that can potentially be targeted by Durvalumab.

Drug: Durvalumab

Rucaparib

EXPERIMENTAL

Rucaparib for patients with a molecular tumor profile that can potentially be targeted by Rucaparib.

Drug: Rucaparib

Axitinib

EXPERIMENTAL

Axitinib for patients with a molecular tumor profile that can potentially be targeted by Axitinib.

Drug: Axitinib

Palbociclib

EXPERIMENTAL

Palbociclib for patients with a molecular tumor profile that can potentially be targeted by Palbociclib.

Drug: Palbociclib

Crizotinib

EXPERIMENTAL

Crizotinib for patients with a molecular tumor profile that can potentially be targeted by Crizotinib.

Drug: Crizotinib

Sunitinib

EXPERIMENTAL

Sunitinib for patients with a molecular tumor profile that can potentially be targeted by Sunitinib.

Drug: Sunitinib

Cabozantinib

EXPERIMENTAL

Cabozantinib for patients with a molecular tumor profile that can potentially be targeted by Cabozantinib.

Drug: Cabozantinib

Abemaciclib

EXPERIMENTAL

Abemaciclib for patients with a molecular tumor profile that can potentially be targeted by Abemaciclib.

Drug: Abemaciclib

Alectinib

EXPERIMENTAL

Alectinib for patients with a molecular tumor profile that can potentially be targeted by Alectinib.

Drug: Alectinib

Atezolizumab/bevacizumab

EXPERIMENTAL

Atezolizumab and bevacizumab (combination treatment) for patients with a molecular tumor profile that can potentially be targeted by Atezolizumab and bevacizumab.

Drug: Atezolizumab and Bevacizumab

Ipilimumab/nivolumab

EXPERIMENTAL

Ipilimumab and nivolumab (combination treatment) for patients with a molecular tumor profile that can potentially be targeted by Ipilimumab and nivolumab.

Drug: Ipilimumab and nivolumab

Entrectinib

EXPERIMENTAL

Entrectinib for patients with a molecular tumor profile that can potentially be targeted by entrectinib.

Drug: Entrectinib

Talazoparib

EXPERIMENTAL

Talazoparib for patients with a molecular tumor profile that can potentially be targeted by talazoparib.

Drug: Talazoparib

dacomitinib

EXPERIMENTAL

Dacomitinib for patients with a molecular tumor profile that can potentially be targeted by dacomitinib.

Drug: Dacomitinib

Lorlatinib

EXPERIMENTAL

Lorlatinib for patients with a molecular tumor profile that can potentially be targeted by lorlatinib.

Drug: Lorlatinib

Erdafitinib

EXPERIMENTAL

Erdafitinib for patients with a molecular tumor profile that can potentially be targeted by erdafitinib.

Drug: Erdafitinib

Alpelisib

EXPERIMENTAL

Alpelisib for patients with a molecular tumor profile that can potentially be targeted by alpelisib.

Drug: Alpelisib

Niraparib

EXPERIMENTAL

Niraparib for patients with a molecular tumor profile that can potentially be targeted by niraparib.

Drug: Niraparib

Pemigatinib

EXPERIMENTAL

Pemigatinib for patients with a molecular tumor profile that can potentially be targeted by pemigatinib.

Drug: Pemigatinib

Selpercatinib

EXPERIMENTAL

Selpercatinib for patients with a molecular tumor profile that can potentially be targeted by selpercatinib.

Drug: Selpercatinib

Tepotinib

EXPERIMENTAL

Tepotinib for patients with a molecular tumor profile that can potentially be targeted by tepotinib.

Drug: Tepotinib

Interventions

Panitumumab DRUG

Panitumumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of panitumumab might be expected based on their molecular tumor profile.

Also known as: Vectibix

Panitumumab

Olaparib DRUG

Olaparib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of olaparib might be expected based on their molecular tumor profile.

Also known as: Lynparza

Olaparib

Dabrafenib DRUG

Dabrafenib treatment for patients with an mutated advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of dabrafenib might be expected based on their molecular tumor profile.

Also known as: Tafinlar

Dabrafenib

Nilotinib DRUG

Nilotinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of nilotinib might be expected based on their molecular tumor profile.

Also known as: Tasigna

Nilotinib

Trametinib DRUG

Trametinib treatment for patients with an mutated advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of trametinib might be expected based on their molecular tumor profile.

Also known as: Mekinist

Trametinib

Erlotinib DRUG

Erlotinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of erlotinib might be expected based on their molecular tumor profile.

Also known as: Tarceva

Erlotinib

Trastuzumab and Pertuzumab (combination treatment) DRUG

Trastuzumab and Pertuzumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of trastuzumab + pertuzumab might be expected based on their molecular tumor profile.

Also known as: Herceptin + Perjeta

Trastuzumab & Pertuzumab (combination)

Vemurafenib and Cobimetinib (combination treatment) DRUG

Vemurafenib + Cobimetinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Vemurafenib + Cobimetinib might be expected based on their molecular tumor profile.

Also known as: Zelboraf + Cotellic

Vemurafenib & Cobimetinib (combination)

Vismodegib DRUG

Vismodegib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of vismodegib might be expected based on their molecular tumor profile.

Also known as: Erivedge

Vismodegib

Regorafenib DRUG

Regorafenib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of vismodegib might be expected based on their molecular tumor profile.

Also known as: Stivarga

Regorafenib

Nivolumab DRUG

Nivolumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of nivolumab might be expected based on their molecular tumor profile.

Also known as: Opdivo

Nivolumab

Afatinib DRUG

Afatinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Afatinib might be expected based on their molecular tumor profile.

Also known as: Giotrif

Afatinib

Dabrafenib and trametinib DRUG

Dabrafenib + trametinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Dabrafenib + Trametinib might be expected based on their molecular tumor profile.

Also known as: Tafinlar and Mekinist

Dabrafenib & trametinib (combination)

Ribociclib DRUG

Ribociclib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Ribociclib might be expected based on their molecular tumor profile.

Also known as: Kisqali

Ribociclib

Lenvatinib DRUG

Lenvatinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Lenvatinib might be expected based on their molecular tumor profile.

Also known as: Lenvima

Lenvatinib

Pembrolizumab DRUG

Pembrolizumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Pembrolizumab might be expected based on their molecular tumor profile.

Also known as: Keytruda

Pembrolizumab

Durvalumab DRUG

Durvalumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Durvalumab might be expected based on their molecular tumor profile.

Also known as: MEDI4736

Durvalumab

Rucaparib DRUG

Rucaparib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Rucaparib might be expected based on their molecular tumor profile.

Also known as: Rubraca

Rucaparib

Axitinib DRUG

Axitinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Axitinib might be expected based on their molecular tumor profile.

Also known as: Inlyta

Axitinib

Palbociclib DRUG

Palbociclib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Palbociclib might be expected based on their molecular tumor profile.

Also known as: Ibrance

Palbociclib

Crizotinib DRUG

Crizotinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Crizotinib might be expected based on their molecular tumor profile.

Also known as: Xalkori

Crizotinib

Sunitinib DRUG

Sunitinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Sunitinib might be expected based on their molecular tumor profile.

Also known as: Sutent

Sunitinib

Cabozantinib DRUG

Cabozantinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Cabozantinib might be expected based on their molecular tumor profile.

Also known as: Cabometyx

Cabozantinib

Abemaciclib DRUG

Abemaciclib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Abemaciclib might be expected based on their molecular tumor profile.

Also known as: Verzenios

Abemaciclib

Alectinib DRUG

Alectinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Alectinib might be expected based on their molecular tumor profile.

Also known as: Alecensa

Alectinib

Atezolizumab and Bevacizumab DRUG

Atezolizumab + Bevacizumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Atezolizumab + Bevacizumab might be expected based on their molecular tumor profile.

Also known as: Tecentriq and Avastin

Atezolizumab/bevacizumab

Ipilimumab and nivolumab DRUG

Ipilimumab+nivolumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of ipilimimab + nivolumab might be expected based on their molecular tumor profile.

Also known as: Yervoy and Opdivo

Ipilimumab/nivolumab

Entrectinib DRUG

Entrectinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of entrectinib might be expected based on their molecular tumor profile.

Also known as: Rozlytrek

Entrectinib

Talazoparib DRUG

Talazoparib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of talazoparib might be expected based on their molecular tumor profile.

Also known as: Talzenna

Talazoparib

Dacomitinib DRUG

Dacomitinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of dacomitinib might be expected based on their molecular tumor profile.

Also known as: Vizimpro

dacomitinib

Lorlatinib DRUG

Lorlatinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of lorlatinib might be expected based on their molecular tumor profile.

Also known as: Lorviqua

Lorlatinib

Erdafitinib DRUG

Erdafitinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of erdafitinib might be expected based on their molecular tumor profile.

Also known as: Balversa

Erdafitinib

Alpelisib DRUG

Alpelisib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of alpelisib might be expected based on their molecular tumor profile.

Also known as: Piqray

Alpelisib

Niraparib DRUG

Niraparib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of niraparib might be expected based on their molecular tumor profile.

Also known as: Zejula

Niraparib

Pemigatinib DRUG

Pemigatinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of pemigatinib might be expected based on their molecular tumor profile.

Also known as: Pemazyre

Pemigatinib

Selpercatinib DRUG

Selpercatinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of selpercatinib might be expected based on their molecular tumor profile.

Also known as: Retsevmo

Selpercatinib

Tepotinib DRUG

Tepotinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of tepotinib might be expected based on their molecular tumor profile.

Also known as: Tepmetko

Tepotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \* For patients with a primary brain tumor: Histologically confirmed recurrent or de novo primary brain tumor, with unequivocal progression after prior therapy, at least 3 months after radiotherapy (either first line chemo-radiotherapy or re-irradiation), and with stable or decreasing dosage of steroids for at least 7 days prior to the baseline MRI scan.
• ECOG performance status 0-2

You may not qualify if:

• Absolute neutrophil count ≥ 1.5 x 109/l
• Hemoglobin \> 5.6 mmol/l
• Platelets \> 75 x 109/l
• Total bilirubin \< 2 x ULN
• AST (SGOT) and ALT (SGPT) \< 2.5 x institutional ULN (or \< 5 x ULN in patients with known hepatic metastases)
• Serum creatinine ≤ 1.5 × ULN or calculated or measured creatinine clearance ≥ 50 mL/min/1.73 m2
• Patients must have objectively measurable disease (by physical or radiographic examination, according to RECIST v1.1 for patients with solid tumors, or according to IMWG, Lugano, RANO or GCIG criteria, resp., for patients with multiple myeloma, non-Hodgkin lymphoma, glioblastoma or ovarian cancer in case of CA125-based evaluation (please refer to appendices for further details).
• Results must be available from a tumor genomic or protein expression test. Eligible tests may include any of the following technologies: fluorescence in situ hybridization (FISH), polymerase chain reaction (PCR), comparative genomic hybridization (CGH), next generation sequencing (NGS) or immunohistochemistry (IHC). The test may have been performed on the primary tumor or a metastatic deposit, in a diagnostic laboratory or within the context of another CPCT study, and must reveal a potentially actionable variant as defined in Section 5. The test results (full pathology or molecular diagnostics report) must be uploaded in the eCRF.
• Patients must have a tumor profile for which treatment with one of the FDA and / or EMA approved (or under revision for approval) targeted anti-cancer drugs included in this study has potential clinical benefit based on preclinical data or clinical information (see section 5).
• The following exceptions are made:
• a. An exception is made for patients with a primary brain tumor, only if the mandatory DRUP pre-treatment biopsy for biomarker analysis cannot safely be obtained:
• The fresh frozen tumor biopsy sample may be replaced by fresh frozen tumor tissue, obtained earlier from recurrent disease, as part of standard of care surgical procedure (i.e., performed at progression)
• If no fresh frozen tumor tissue is available for NGS, and the risk of obtaining a new tumor biopsy is considered too high, no biopsy will be required. In this case, the study coordinators must be informed in advance, and there will be no reimbursement for the biopsy procedure.
• c. An exception is made for patients that underwent an allogeneic hematopoietic stem cell transplantation prior to study enrollment, since this will prevent a correct WGS analysis due to a mismatch between the biopsy specimen and the required blood sample.
• Ability to understand and the willingness to sign a written informed consent document.

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead
• 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

Study Sites (36)

Noordwest ziekenhuisgroep Alkmaar (NWZ)

Alkmaar, Netherlands

RECRUITING

Ziekenhuisgroep Twente

Almelo, Netherlands

RECRUITING

Meander medisch centrum

Amersfoort, 3818 ES, Netherlands

RECRUITING

Netherlands Cancer Institute

Amsterdam, 1066CX, Netherlands

RECRUITING

Amsterdam UMC, locatie VUmc

Amsterdam, 1081 HV, Netherlands

RECRUITING

Amsterdam UMC, locatie AMC

Amsterdam, 1105AZ, Netherlands

ACTIVE NOT RECRUITING

Onze Lieve Vrouwe Gasthuis (OLVG)

Amsterdam, Netherlands

RECRUITING

Gelre ziekenhuizen

Apeldoorn, Netherlands

RECRUITING

Rijnstate ziekenhuis

Arnhem, Netherlands

RECRUITING

Amphia Ziekenhuis

Breda, Netherlands

RECRUITING

Reiner de Graaf Gasthuis

Delft, Netherlands

RECRUITING

Deventer ziekenhuis

Deventer, Netherlands

RECRUITING

Nij Smellinghe Ziekenhuis

Drachten, Netherlands

RECRUITING

Ziekenhuis Gelderse Vallei

Ede, Netherlands

RECRUITING

Maxima Medisch Centrum

Eindhoven, 5631 BM, Netherlands

RECRUITING

Zuyderland medisch centrum

Geleen, 6162 BG, Netherlands

RECRUITING

Rivas zorggroep

Gorinchem, Netherlands

RECRUITING

Martini ziekenhuis

Groningen, Netherlands

RECRUITING

University Medical Center Groningen

Groningen, Netherlands

RECRUITING

Spaarne gasthuis

Haarlem, Netherlands

RECRUITING

Tergooi MC

Hilversum, Netherlands

NOT YET RECRUITING

Treant zorggroep

Hoogeveen, Netherlands

RECRUITING

Medisch Centrum Leeuwaarden

Leeuwarden, Netherlands

RECRUITING

Leiden University Medical Center

Leiden, Netherlands

RECRUITING

Maastricht University Medical Center

Maastricht, Netherlands

RECRUITING

St. Antonius ziekenhuis

Nieuwegein, Netherlands

RECRUITING

Radboud umc

Nijmegen, 6225GA, Netherlands

RECRUITING

Bravis ziekenhuis

Roosendaal, Netherlands

RECRUITING

St. Fransicus Gasthuis

Rotterdam, 3045 PM, Netherlands

RECRUITING

Erasmus MC

Rotterdam, Netherlands

RECRUITING

Haaglanden medisch centrum

The Hague, Netherlands

RECRUITING

Haga ziekenhuis

The Hague, Netherlands

RECRUITING

Elisabeth-TweeSteden Ziekenhuis

Tilburg, 5022 GC, Netherlands

RECRUITING

University Medical Center Utrecht

Utrecht, 3584CX, Netherlands

RECRUITING

VieCuri medisch centrum

Venlo, Netherlands

RECRUITING

Isala klinieken

Zwolle, Netherlands

RECRUITING

Related Publications (5)

• Geurts BS, Zeverijn LJ, Leek LVM, van Berge Henegouwen JM, Hoes LR, van der Wijngaart H, van der Noort V, van de Haar J, van Ommen-Nijhof A, Kok M, Roepman P, Jansen AML, de Leng WWJ, de Jonge MJA, Hoeben A, van Herpen CML, Westgeest HM, Wessels LFA, Verheul HMW, Gelderblom H, Voest EE. Efficacy of Pembrolizumab and Biomarker Analysis in Patients with WGS-Based Intermediate to High Tumor Mutational Load: Results from the Drug Rediscovery Protocol. Clin Cancer Res. 2024 Sep 3;30(17):3735-3746. doi: 10.1158/1078-0432.CCR-24-0011.

  PMID: 38630551 DERIVED

• Zeverijn LJ, Looze EJ, Thavaneswaran S, van Berge Henegouwen JM, Simes RJ, Hoes LR, Sjoquist KM, van der Wijngaart H, Sebastian L, Geurts BS, Lee CK, de Wit GF, Espinoza D, Roepman P, Lin FP, Jansen AML, de Leng WWJ, van der Noort V, Leek LVM, de Vos FYFL, van Herpen CML, Gelderblom H, Verheul HMW, Thomas DM, Voest EE. 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. Int J Cancer. 2023 Oct 1;153(7):1413-1422. doi: 10.1002/ijc.34649. Epub 2023 Jul 10.

  PMID: 37424386 DERIVED

• Geurts BS, Battaglia TW, van Berge Henegouwen JM, Zeverijn LJ, de Wit GF, Hoes LR, van der Wijngaart H, van der Noort V, Roepman P, de Leng WWJ, Jansen AML, Opdam FL, de Jonge MJA, Cirkel GA, Labots M, Hoeben A, Kerver ED, Bins AD, Erdkamp FGL, van Rooijen JM, Houtsma D, Hendriks MP, de Groot JB, Verheul HMW, Gelderblom H, Voest EE. Efficacy, safety and biomarker analysis of durvalumab in patients with mismatch-repair deficient or microsatellite instability-high solid tumours. BMC Cancer. 2023 Mar 4;23(1):205. doi: 10.1186/s12885-023-10663-2.

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MeSH Terms

Conditions

Neoplasms

Interventions

Panitumumab; olaparib; dabrafenib; nilotinib; trametinib; Erlotinib Hydrochloride; Trastuzumab; pertuzumab; Vemurafenib; cobimetinib; HhAntag691; regorafenib; Nivolumab; Afatinib; ribociclib; lenvatinib; pembrolizumab; durvalumab; rucaparib; Axitinib; palbociclib; Crizotinib; Sunitinib; cabozantinib; abemaciclib; alectinib; atezolizumab; Bevacizumab; Ipilimumab; entrectinib; talazoparib; dacomitinib; lorlatinib; erdafitinib; Alpelisib; niraparib; pemigatinib; selpercatinib; tepotinib

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Indoles; Benzamides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Piperidines; Aminopyridines; Pyridines; Pyrroles

Study Officials

• E.E. Voest, prof.

  The Netherlands Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

E.E. Voest, prof.

CONTACT

0031205129111; DRUP@nki.nl

K. Verkerk, MD

CONTACT

0031205129111; DRUP@nki.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2016
• First Posted: October 5, 2016
• Study Start: August 1, 2016
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (36)