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The Drug Rediscovery Protocol...

The Drug Rediscovery Protocol (DRUP Trial)

Last Updated: 2024-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

1550 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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Problem description: evidence is building that matching targeted agents to tumor characteristics can improve outcomes. Such reports have fueled interest among patients and physicians to use molecular testing for treatment planning when standard treatment options have been exhausted. When oncologists aim to provide such personalized treatment to their patients though, obtaining the drugs can be challenging since off-label prescribing, while legal, is generally not reimbursed by insurance companies. Furthermore, outcomes of off-label treatment in routine clinical practice are not systematically recorded. As a result, the research and clinical communities have limited insight in these outcomes, leading to repetitive use of ineffective treatment for some tumor types, while effective treatment strategies might be missed for others. The latter is especially relevant for 'orphan diseases', that are too rare to conduct formal phase II and III trials. In summary, there is a lack of access to potentially effective therapy on one hand, and a lack of knowledge on broader use of such therapies on the other, altogether leading to sub-optimal use of available resources.

Envisioned solution and study aim: creation of a drug-access program, in which patients are treated with registered targeted therapy matched to their molecular tumor profile, and in which the outcomes of such therapies are recorded systematically, per tumor profile and tumor type (this is important since it is becoming increasingly clear that the tissue of origin is an important determinant of outcome of genetic abnormalities). We hereby aim to improve and broaden the use of registered targeted therapy, whilst facilitating patient access to such therapy.

Plan of investigation: patients will be treated with approved targeted agents, selected based on results of a molecular profiling test of the patient's tumor. Eligible patients will have exhausted standard treatment options, and their tumor must harbor a potentially actionable molecular variant as defined in the protocol. The study will provide a tumor board to help physicians understand the profiling test results and treatment options, and will enable insights about the utility of this approach. In addition, next generation sequencing will be performed on fresh tumor biopsies for additional biomarker discovery. Patients from the Netherlands and the USA will be included in two similar though independent protocols (DRUP and TAPUR), allowing data-exchange and empowering of both trials.

Expected outcome: early signs of clinical activity of approved drugs outside their label, providing effective personalized treatment options, improved patient outcomes and access to targeted therapy.

Conditions

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Cancer Tumors Neoplasm Neoplasia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Panitumumab

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

Group Type EXPERIMENTAL

Panitumumab

Intervention Type 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.

Olaparib

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

Group Type EXPERIMENTAL

Olaparib

Intervention Type 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.

Dabrafenib

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

Group Type EXPERIMENTAL

Dabrafenib

Intervention Type 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.

Nilotinib

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

Group Type EXPERIMENTAL

Nilotinib

Intervention Type 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.

Trametinib

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

Group Type EXPERIMENTAL

Trametinib

Intervention Type 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.

Erlotinib

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

Group Type EXPERIMENTAL

Erlotinib

Intervention Type 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.

Trastuzumab & Pertuzumab (combination)

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

Group Type EXPERIMENTAL

Trastuzumab and Pertuzumab (combination treatment)

Intervention Type 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.

Vemurafenib & Cobimetinib (combination)

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

Group Type EXPERIMENTAL

Vemurafenib and Cobimetinib (combination treatment)

Intervention Type 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.

Vismodegib

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

Group Type EXPERIMENTAL

Vismodegib

Intervention Type 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.

Regorafenib

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

Group Type EXPERIMENTAL

Regorafenib

Intervention Type 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.

Nivolumab

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

Group Type EXPERIMENTAL

Nivolumab

Intervention Type 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.

Afatinib

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

Group Type EXPERIMENTAL

Afatinib

Intervention Type 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.

Dabrafenib & trametinib (combination)

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

Group Type EXPERIMENTAL

Dabrafenib and trametinib

Intervention Type 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.

Ribociclib

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

Group Type EXPERIMENTAL

Ribociclib

Intervention Type 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.

Lenvatinib

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

Group Type EXPERIMENTAL

Lenvatinib

Intervention Type 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.

Pembrolizumab

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

Group Type EXPERIMENTAL

Pembrolizumab

Intervention Type 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.

Durvalumab

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

Group Type EXPERIMENTAL

Durvalumab

Intervention Type 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.

Rucaparib

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

Group Type EXPERIMENTAL

Rucaparib

Intervention Type 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.

Axitinib

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

Group Type EXPERIMENTAL

Axitinib

Intervention Type 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.

Palbociclib

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

Group Type EXPERIMENTAL

Palbociclib

Intervention Type 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.

Crizotinib

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

Group Type EXPERIMENTAL

Crizotinib

Intervention Type 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.

Sunitinib

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

Group Type EXPERIMENTAL

Sunitinib

Intervention Type 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.

Cabozantinib

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

Group Type EXPERIMENTAL

Cabozantinib

Intervention Type 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.

Abemaciclib

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

Group Type EXPERIMENTAL

Abemaciclib

Intervention Type 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.

Alectinib

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

Group Type EXPERIMENTAL

Alectinib

Intervention Type 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.

Atezolizumab/bevacizumab

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

Group Type EXPERIMENTAL

Atezolizumab and Bevacizumab

Intervention Type 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.

Ipilimumab/nivolumab

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

Group Type EXPERIMENTAL

Ipilimumab and nivolumab

Intervention Type 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.

Entrectinib

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

Group Type EXPERIMENTAL

Entrectinib

Intervention Type 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.

Talazoparib

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

Group Type EXPERIMENTAL

Talazoparib

Intervention Type 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.

dacomitinib

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

Group Type EXPERIMENTAL

Dacomitinib

Intervention Type 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.

Lorlatinib

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

Group Type EXPERIMENTAL

Lorlatinib

Intervention Type 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.

Erdafitinib

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

Group Type EXPERIMENTAL

Erdafitinib

Intervention Type 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.

Alpelisib

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

Group Type EXPERIMENTAL

Alpelisib

Intervention Type 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.

Niraparib

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

Group Type EXPERIMENTAL

Niraparib

Intervention Type 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.

Pemigatinib

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

Group Type EXPERIMENTAL

Pemigatinib

Intervention Type 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.

Selpercatinib

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

Group Type EXPERIMENTAL

Selpercatinib

Intervention Type 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.

Tepotinib

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

Group Type EXPERIMENTAL

Tepotinib

Intervention Type 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.

Interventions

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Panitumumab

Intervention Type DRUG

Olaparib

Intervention Type DRUG

Dabrafenib

Intervention Type DRUG

Nilotinib

Intervention Type DRUG

Trametinib

Intervention Type DRUG

Erlotinib

Intervention Type DRUG

Trastuzumab and Pertuzumab (combination treatment)

Intervention Type DRUG

Vemurafenib and Cobimetinib (combination treatment)

Intervention Type DRUG

Vismodegib

Intervention Type DRUG

Regorafenib

Intervention Type DRUG

Nivolumab

Intervention Type DRUG

Afatinib

Intervention Type DRUG

Dabrafenib and trametinib

Intervention Type DRUG

Ribociclib

Intervention Type DRUG

Lenvatinib

Intervention Type DRUG

Pembrolizumab

Intervention Type DRUG

Durvalumab

Intervention Type DRUG

Rucaparib

Intervention Type DRUG

Axitinib

Intervention Type DRUG

Palbociclib

Intervention Type DRUG

Crizotinib

Intervention Type DRUG

Sunitinib

Intervention Type DRUG

Cabozantinib

Intervention Type DRUG

Abemaciclib

Intervention Type DRUG

Alectinib

Intervention Type DRUG

Atezolizumab and Bevacizumab

Intervention Type DRUG

Ipilimumab and nivolumab

Intervention Type DRUG

Entrectinib

Intervention Type DRUG

Talazoparib

Intervention Type DRUG

Dacomitinib

Intervention Type DRUG

Lorlatinib

Intervention Type DRUG

Erdafitinib

Intervention Type DRUG

Alpelisib

Intervention Type DRUG

Niraparib

Intervention Type DRUG

Pemigatinib

Intervention Type DRUG

Selpercatinib

Intervention Type DRUG

Tepotinib

Intervention Type DRUG

Other Intervention Names

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Vectibix Lynparza Tafinlar Tasigna Mekinist Tarceva Herceptin + Perjeta Zelboraf + Cotellic Erivedge Stivarga Opdivo Giotrif Tafinlar and Mekinist Kisqali Lenvima Keytruda MEDI4736 Rubraca Inlyta Ibrance Xalkori Sutent Cabometyx Verzenios Alecensa Tecentriq and Avastin Yervoy and Opdivo Rozlytrek Talzenna Vizimpro Lorviqua Balversa Piqray Zejula Pemazyre Retsevmo Tepmetko

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. ECOG performance status 0-2

Exclusion Criteria

1. Absolute neutrophil count ≥ 1.5 x 109/l
2. Hemoglobin \> 5.6 mmol/l
3. Platelets \> 75 x 109/l
4. Total bilirubin \< 2 x ULN
5. AST (SGOT) and ALT (SGPT) \< 2.5 x institutional ULN (or \< 5 x ULN in patients with known hepatic metastases)
6. Serum creatinine ≤ 1.5 × ULN or calculated or measured creatinine clearance ≥ 50 mL/min/1.73 m2
4. 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).
5. 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.
6. 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).
7. new (obtained ≤2 months before inclusion, and without any type of anti-cancer therapy within those ≤2 months) fresh frozen tumor biopsy specimen for extensive biomarker testing is mandatory before the start of treatment with a targeted agent included in the protocol. Alternatively, fresh frozen tumor tissue acquired in the context of a standard care procedure may be used, provided that no systemic anti-cancer treatment was given between the procedure and start of study treatment within DRUP.

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:
1. 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)
2. 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.

b. In case WGS is performed on tumor tissue outside the context of a clinical trial before inclusion, and without any type of anti-cancer therapy between the collection of tissue and inclusion in DRUP, this can replace the DRUP pre-treatment biopsy, provided that the patient gives consent to use his/her WGS data for biomarker analysis in DRUP.

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.
8. Ability to understand and the willingness to sign a written informed consent document.
9. For orally administered drugs, the patient must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome.
10. Because of the risks of drug treatment to the developing foetus, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation, and for four months following completion of study therapy. Male patients should avoid impregnating a female partner. Male patients, even if surgically sterilized, (i.e. post-vasectomy) must agree to one of the following: practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or completely abstain from sexual intercourse.

1. Ongoing toxicity \> grade 2, other than alopecia.
2. Patient is receiving any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement). Required wash out period prior to starting study treatment is at least two weeks. An exception is made for:

* Patients suffering from CRPC are allowed to continue androgen deprivation therapy.
* Medications that are prescribed for supportive care but may potentially have an anti-cancer effect (e.g., megestrol acetate, bisphosphonates). These medications must have been started ≥ 1 week prior to enrollment on this study.
3. Patient is pregnant or nursing.
4. Patients with known active progressive brain metastases. Patients with previously treated brain metastases are eligible, provided that the patient has not experienced a seizure or had a clinically significant change in neurological status within the 3 months prior to registration. All patients with previously treated brain metastases must be stable for at least 1 month after completion of treatment and off steroid treatment prior to study enrollment.

1. Patients who require anti-convulsant therapy must be taking non-enzyme inducing antiepileptic drugs (non-EIAED). EIAED are prohibited. Patients previously on EIAED must be switched to non-EIAED at least 2 weeks prior to randomization.
2. No radiotherapy within the three months prior to the diagnosis of progression.
3. No radiotherapy with a dose over 65 Gy, stereotactic radiosurgery or brachytherapy unless the recurrence is histologically proven.
5. Patients with clinically significant preexisting cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure are not eligible.
6. Patients with known left ventricular ejection fraction (LVEF) \< 40% are not eligible
7. Patients with stroke (including TIA) or acute myocardial infarction within 3 months before the first dose of study treatment are not eligible
8. Patients with any other clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements including, but not limited to: ongoing or active infection, significant uncontrolled hypertension, or severe psychiatric illness/social situations.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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E.E. Voest, prof.

Role: PRINCIPAL_INVESTIGATOR

The Netherlands Cancer Institute

Locations

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Noordwest ziekenhuisgroep Alkmaar (NWZ)

Alkmaar, , Netherlands

Site Status RECRUITING

Ziekenhuisgroep Twente

Almelo, , Netherlands

Site Status RECRUITING

Meander medisch centrum

Amersfoort, , Netherlands

Site Status RECRUITING

Netherlands Cancer Institute

Amsterdam, , Netherlands

Site Status RECRUITING

Amsterdam UMC, locatie VUmc

Amsterdam, , Netherlands

Site Status RECRUITING

Amsterdam UMC, locatie AMC

Amsterdam, , Netherlands

Site Status ACTIVE_NOT_RECRUITING

Onze Lieve Vrouwe Gasthuis (OLVG)

Amsterdam, , Netherlands

Site Status RECRUITING

Gelre ziekenhuizen

Apeldoorn, , Netherlands

Site Status RECRUITING

Rijnstate ziekenhuis

Arnhem, , Netherlands

Site Status RECRUITING

Amphia Ziekenhuis

Breda, , Netherlands

Site Status RECRUITING

Reiner de Graaf Gasthuis

Delft, , Netherlands

Site Status RECRUITING

Deventer ziekenhuis

Deventer, , Netherlands

Site Status RECRUITING

Nij Smellinghe Ziekenhuis

Drachten, , Netherlands

Site Status RECRUITING

Ziekenhuis Gelderse Vallei

Ede, , Netherlands

Site Status RECRUITING

Maxima Medisch Centrum

Eindhoven, , Netherlands

Site Status RECRUITING

Zuyderland medisch centrum

Geleen, , Netherlands

Site Status RECRUITING

Rivas zorggroep

Gorinchem, , Netherlands

Site Status RECRUITING

Martini ziekenhuis

Groningen, , Netherlands

Site Status RECRUITING

University Medical Center Groningen

Groningen, , Netherlands

Site Status RECRUITING

Spaarne gasthuis

Haarlem, , Netherlands

Site Status RECRUITING

Tergooi MC

Hilversum, , Netherlands

Site Status NOT_YET_RECRUITING

Treant zorggroep

Hoogeveen, , Netherlands

Site Status RECRUITING

Medisch Centrum Leeuwaarden

Leeuwarden, , Netherlands

Site Status RECRUITING

Leiden University Medical Center

Leiden, , Netherlands

Site Status RECRUITING

Maastricht University Medical Center

Maastricht, , Netherlands

Site Status RECRUITING

St. Antonius ziekenhuis

Nieuwegein, , Netherlands

Site Status RECRUITING

Radboud umc

Nijmegen, , Netherlands

Site Status RECRUITING

Bravis ziekenhuis

Roosendaal, , Netherlands

Site Status RECRUITING

St. Fransicus Gasthuis

Rotterdam, , Netherlands

Site Status RECRUITING

Erasmus MC

Rotterdam, , Netherlands

Site Status RECRUITING

Haaglanden medisch centrum

The Hague, , Netherlands

Site Status RECRUITING

Haga ziekenhuis

The Hague, , Netherlands

Site Status RECRUITING

Elisabeth-TweeSteden Ziekenhuis

Tilburg, , Netherlands

Site Status RECRUITING

University Medical Center Utrecht

Utrecht, , Netherlands

Site Status RECRUITING

VieCuri medisch centrum

Venlo, , Netherlands

Site Status RECRUITING

Isala klinieken

Zwolle, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

E.E. Voest, prof.

Role: CONTACT

[email protected]

0031205129111

K. Verkerk, MD

Role: CONTACT

[email protected]

0031205129111

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

M.P. Hendriks, MD, PhD

Role: primary

E. Siemerink

Role: primary

G.A. Cirkel, MD

Role: primary

E.E. Voest, prof.

Role: primary

[email protected]

0031205129111

K Verkerk, MD

Role: backup

[email protected]

0031205129111

M Labots

Role: primary

E.D. Kerver

Role: primary

S.C.S. Tromp

Role: primary

T. van Voorthuizen

Role: primary

H. Westgeest, MD, PhD

Role: primary

A. Vulink

Role: primary

A. Imholz

Role: primary

S. Hovenga

Role: primary

P. de Mol

Role: primary

G Vreugdenhil, MD, PhD

Role: primary

F.L.G. Erdkamp, MD

Role: primary

M.A. Davidis

Role: primary

J. van Rooijen

Role: primary

D.J.A. de Groot, MD, PhD

Role: primary

G.J. de Klerk

Role: primary

H.P. van den Berg

Role: primary

C. Oldenhuis

Role: primary

H. de Graaf

Role: primary

A.J. Gelderblom, MD, PhD

Role: primary

A. Hoeben, MD, PhD

Role: primary

M. Los

Role: primary

C.M.L. van Herpen, MD, PhD

Role: primary

S. Boudewijns

Role: primary

A P Hamberg, MD

Role: primary

M.J.A. de Jonge, MD, PhD

Role: primary

F. Jeurissen

Role: primary

D. Hautsma

Role: primary

L.V. Beerepoot, MD, PhD

Role: primary

L.A. Devriese, MD, PhD

Role: primary

Y. van der Wouw

Role: primary

J.W.B. de Groot

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED

PMID: 38630551 (View on PubMed)

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.

Reference Type DERIVED

PMID: 37424386 (View on PubMed)

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.

Reference Type DERIVED

PMID: 36870947 (View on PubMed)

van Berge Henegouwen JM, van der Wijngaart H, Zeverijn LJ, Hoes LR, Meertens M, Huitema ADR, Devriese LA, Labots M, Verheul HMW, Voest EE, Gelderblom H. 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. Cancer Chemother Pharmacol. 2022 Jul;90(1):97-104. doi: 10.1007/s00280-022-04437-z. Epub 2022 May 22.

Reference Type DERIVED

PMID: 35598186 (View on PubMed)

Nakauma-Gonzalez JA, Rijnders M, van Riet J, van der Heijden MS, Voortman J, Cuppen E, Mehra N, van Wilpe S, Oosting SF, Rijstenberg LL, Westgeest HM, Zwarthoff EC, de Wit R, van der Veldt AAM, van de Werken HJG, Lolkema MPJ, Boormans JL. Comprehensive Molecular Characterization Reveals Genomic and Transcriptomic Subtypes of Metastatic Urothelial Carcinoma. Eur Urol. 2022 Apr;81(4):331-336. doi: 10.1016/j.eururo.2022.01.026. Epub 2022 Jan 25.

Reference Type DERIVED

PMID: 35086719 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

M15DRU

Identifier Type: -

Identifier Source: org_study_id

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