- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02925234
The Drug Rediscovery Protocol (DRUP Trial) (DRUP)
A Dutch National Study on Behalf of the CPCT to Facilitate Patient Access to Commercially Available, Targeted Anti-cancer Drugs to Determine the Potential Efficacy in Treatment of Advanced Cancers With a Known Molecular Profile
Study Overview
Status
Intervention / Treatment
- Drug: Alectinib
- Drug: Axitinib
- Drug: Panitumumab
- Drug: Olaparib
- Drug: Dabrafenib
- Drug: Nilotinib
- Drug: Trametinib
- Drug: Erlotinib
- Drug: Trastuzumab and Pertuzumab (combination treatment)
- Drug: Vemurafenib and Cobimetinib (combination treatment)
- Drug: Vismodegib
- Drug: Regorafenib
- Drug: Nivolumab
- Drug: Afatinib
- Drug: Dabrafenib and trametinib
- Drug: Ribociclib
- Drug: Lenvatinib
- Drug: Pembrolizumab
- Drug: Durvalumab
- Drug: Rucaparib
- Drug: Palbociclib
- Drug: Crizotinib
- Drug: Sunitinib
- Drug: Cabozantinib
- Drug: Abemaciclib
- Drug: Atezolizumab and Bevacizumab
- Drug: Ipilimumab and nivolumab
- Drug: Entrectinib
- Drug: Talazoparib
- Drug: Dacomitinib
- Drug: Lorlatinib
- Drug: Erdafitinib
- Drug: Alpelisib
- Drug: Niraparib
- Drug: Pemigatinib
- Drug: Selpercatinib
- Drug: Tepotinib
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: E.E. Voest, prof.
- Phone Number: 0031205129111
- Email: DRUP@nki.nl
Study Contact Backup
- Name: K. Verkerk, MD
- Phone Number: 0031205129111
- Email: DRUP@nki.nl
Study Locations
-
-
-
Alkmaar, Netherlands
- Recruiting
- Noordwest ziekenhuisgroep Alkmaar (NWZ)
-
Contact:
- M.P. Hendriks, MD, PhD
-
Principal Investigator:
- M.P. Hendriks, MD, PhD
-
Almelo, Netherlands
- Recruiting
- Ziekenhuisgroep Twente
-
Contact:
- E. Siemerink
-
Principal Investigator:
- E. Siemerink
-
Amersfoort, Netherlands, 3818 ES
- Recruiting
- Meander Medisch Centrum
-
Principal Investigator:
- G.A. Cirkel, MD
-
Contact:
- G.A. Cirkel, MD
-
Amsterdam, Netherlands, 1066CX
- Recruiting
- Netherlands Cancer Institute
-
Contact:
- E.E. Voest, prof.
- Phone Number: 0031205129111
- Email: DRUP@nki.nl
-
Contact:
- K Verkerk, MD
- Phone Number: 0031205129111
- Email: DRUP@nki.nl
-
Amsterdam, Netherlands
- Recruiting
- Onze Lieve Vrouwe Gasthuis (OLVG)
-
Contact:
- E.D. Kerver
-
Principal Investigator:
- E.D. Kerver
-
Amsterdam, Netherlands, 1081 HV
- Recruiting
- Amsterdam UMC, locatie VUmc
-
Contact:
- M Labots
-
Principal Investigator:
- M Labots
-
Amsterdam, Netherlands, 1105AZ
- Active, not recruiting
- Amsterdam UMC, Locatie AMC
-
Apeldoorn, Netherlands
- Recruiting
- Gelre Ziekenhuizen
-
Contact:
- S.C.S. Tromp
-
Principal Investigator:
- S.C.S. Tromp
-
Arnhem, Netherlands
- Recruiting
- Rijnstate Ziekenhuis
-
Contact:
- T. van Voorthuizen
-
Principal Investigator:
- T. van Voorthuizen
-
Breda, Netherlands
- Recruiting
- Amphia Ziekenhuis
-
Contact:
- H. Westgeest, MD, PhD
-
Principal Investigator:
- H. Westgeest, MD, PhD
-
Delft, Netherlands
- Recruiting
- Reiner de Graaf Gasthuis
-
Principal Investigator:
- A. Vulink
-
Contact:
- A. Vulink
-
Den Haag, Netherlands
- Recruiting
- HAGA ziekenhuis
-
Contact:
- D. Hautsma
-
Principal Investigator:
- D. Hautsma
-
Den Haag, Netherlands
- Recruiting
- Haaglanden Medisch Centrum
-
Contact:
- F. Jeurissen
-
Principal Investigator:
- F. Jeurissen
-
Deventer, Netherlands
- Recruiting
- Deventer Ziekenhuis
-
Contact:
- A. Imholz
-
Principal Investigator:
- A. Imholz
-
Drachten, Netherlands
- Recruiting
- Nij Smellinghe Ziekenhuis
-
Contact:
- S. Hovenga
-
Principal Investigator:
- S. Hovenga
-
Ede, Netherlands
- Recruiting
- Ziekenhuis Gelderse Vallei
-
Contact:
- P. de Mol
-
Principal Investigator:
- P. de Mol
-
Eindhoven, Netherlands, 5631 BM
- Recruiting
- Maxima Medisch Centrum
-
Contact:
- G Vreugdenhil, MD, PhD
-
Principal Investigator:
- G Vreugdenhil, MD, PhD
-
Geleen, Netherlands, 6162 BG
- Recruiting
- Zuyderland Medisch Centrum
-
Contact:
- F.L.G. Erdkamp, MD
-
Principal Investigator:
- F.L.G. Erdkamp, MD
-
Gorinchem, Netherlands
- Recruiting
- Rivas zorggroep
-
Contact:
- M.A. Davidis
-
Principal Investigator:
- M.A. Davidis
-
Groningen, Netherlands
- Recruiting
- University Medical Center Groningen
-
Contact:
- D.J.A. de Groot, MD, PhD
-
Principal Investigator:
- D.J.A. de Groot, MD, PhD
-
Groningen, Netherlands
- Recruiting
- Martini Ziekenhuis
-
Contact:
- J. van Rooijen
-
Principal Investigator:
- J. van Rooijen
-
Haarlem, Netherlands
- Recruiting
- Spaarne Gasthuis
-
Contact:
- G.J. de Klerk
-
Principal Investigator:
- G.J. de Klerk
-
Hilversum, Netherlands
- Not yet recruiting
- Tergooi MC
-
Contact:
- H.P. van den Berg
-
Principal Investigator:
- H.P. van den Berg
-
Hoogeveen, Netherlands
- Recruiting
- Treant zorggroep
-
Contact:
- C. Oldenhuis
-
Principal Investigator:
- C. Oldenhuis
-
Leeuwarden, Netherlands
- Recruiting
- Medisch Centrum Leeuwaarden
-
Contact:
- H. de Graaf
-
Principal Investigator:
- H. de Graaf
-
Leiden, Netherlands
- Recruiting
- Leiden University Medical Center
-
Contact:
- A.J. Gelderblom, MD, PhD
-
Principal Investigator:
- A.J. Gelderblom, MD, PhD
-
Maastricht, Netherlands
- Recruiting
- Maastricht University Medical Center
-
Contact:
- A. Hoeben, MD, PhD
-
Principal Investigator:
- A. Hoeben, MD, PhD
-
NIjmegen, Netherlands, 6225GA
- Recruiting
- Radboud UMC
-
Contact:
- C.M.L. van Herpen, MD, PhD
-
Principal Investigator:
- C.M.L. van Herpen, MD, PhD
-
Nieuwegein, Netherlands
- Recruiting
- St. Antonius Ziekenhuis
-
Contact:
- M. Los
-
Principal Investigator:
- M. Los
-
Roosendaal, Netherlands
- Recruiting
- Bravis Ziekenhuis
-
Contact:
- S. Boudewijns
-
Principal Investigator:
- S. Boudewijns
-
Rotterdam, Netherlands
- Recruiting
- Erasmus MC
-
Contact:
- M.J.A. de Jonge, MD, PhD
-
Principal Investigator:
- M.J.A. de Jonge, MD, PhD
-
Rotterdam, Netherlands, 3045 PM
- Recruiting
- St. Fransicus Gasthuis
-
Contact:
- A P Hamberg, MD
-
Principal Investigator:
- A P Hamberg, MD
-
Tilburg, Netherlands, 5022 GC
- Recruiting
- Elisabeth-TweeSteden Ziekenhuis
-
Contact:
- L.V. Beerepoot, MD, PhD
-
Principal Investigator:
- L.V. Beerepoot, MD, PhD
-
Utrecht, Netherlands, 3584CX
- Recruiting
- University Medical Center Utrecht
-
Contact:
- L.A. Devriese, MD, PhD
-
Principal Investigator:
- L.A. Devriese, MD, PhD
-
Venlo, Netherlands
- Recruiting
- VieCuri Medisch Centrum
-
Contact:
- Y. van der Wouw
-
Principal Investigator:
- Y. van der Wouw
-
Zwolle, Netherlands
- Recruiting
- Isala Klinieken
-
Contact:
- J.W.B. de Groot
-
Principal Investigator:
- J.W.B. de Groot
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
Patients must have acceptable organ function as defined below. However, specific inclusion/exclusion criteria specified in the drug-specific study manual will take precedence:
- 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).
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:
- 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.
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.
- Ability to understand and the willingness to sign a written informed consent document.
- For orally administered drugs, the patient must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome.
- 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.
Exclusion Criteria:
- Ongoing toxicity > grade 2, other than alopecia.
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.
- Patient is pregnant or nursing.
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.
* Additional exclusion criteria specific for glioblastoma patients:
- 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.
- No radiotherapy within the three months prior to the diagnosis of progression.
- No radiotherapy with a dose over 65 Gy, stereotactic radiosurgery or brachytherapy unless the recurrence is histologically proven.
- 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.
- Patients with known left ventricular ejection fraction (LVEF) < 40% are not eligible
- Patients with stroke (including TIA) or acute myocardial infarction within 3 months before the first dose of study treatment are not eligible
- 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.
For each drug included in this protocol, specific inclusion and exclusion criteria (based on the Package Insert or manufacturers recommendations) may also apply. These can be found in the supplemental information about each agent included in the drug-specific study manuals. Drug-specific inclusion and exclusion criteria will take precedence over the inclusion/exclusion criteria listed above.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Alectinib
Alectinib for patients with a molecular tumor profile that can potentially be targeted by Alectinib.
|
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.
Other Names:
|
Experimental: Axitinib
Axitinib for patients with a molecular tumor profile that can potentially be targeted by Axitinib.
|
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.
Other Names:
|
Experimental: Panitumumab
Panitumumab for patients with a molecular tumor profile that can potentially be targeted by Panitumumab.
|
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.
Other Names:
|
Experimental: Olaparib
Olaparib for patients with a molecular tumor profile that can potentially be targeted by Olaparib.
|
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.
Other Names:
|
Experimental: Dabrafenib
Dabrafenib for patients with a molecular tumor profile that can potentially be targeted by Dabrafenib.
|
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.
Other Names:
|
Experimental: Nilotinib
Nilotinib for patients with a molecular tumor profile that can potentially be targeted by nilotinib.
|
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.
Other Names:
|
Experimental: Trametinib
Trametinib for patients with a molecular tumor profile that can potentially be targeted by trametinib.
|
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.
Other Names:
|
Experimental: Erlotinib
Erlotinib for patients with a molecular tumor profile that can potentially be targeted by erlotinib.
|
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.
Other Names:
|
Experimental: Trastuzumab & Pertuzumab (combination)
Trastuzumab and Pertuzumab (combination treatment) for patients with a molecular tumor profile that can potentially be targeted by Trastuzumab and Pertuzumab.
|
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.
Other Names:
|
Experimental: Vemurafenib & Cobimetinib (combination)
Vemurafenib and Cobimetinib (combination treatment) for patients with a molecular tumor profile that can potentially be targeted by Vemurafenib and Cobimetinib.
|
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.
Other Names:
|
Experimental: Vismodegib
Vismodegib for patients with a molecular tumor profile that can potentially be targeted by vismodegib.
|
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.
Other Names:
|
Experimental: Regorafenib
Regorafenib for patients with a molecular tumor profile that can potentially be targeted by regorafenib.
|
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.
Other Names:
|
Experimental: Nivolumab
Nivolumab for patients with a molecular tumor profile that can potentially be targeted by nivolumab.
|
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.
Other Names:
|
Experimental: Afatinib
Afatinib for patients with a molecular tumor profile that can potentially be targeted by Afatinib.
|
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.
Other Names:
|
Experimental: Dabrafenib & trametinib (combination)
Dabrafenib and trametinib (combination treatment) for patients with a molecular tumor profile that can potentially be targeted by Dabrafenib and trametinib.
|
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.
Other Names:
|
Experimental: Ribociclib
Ribociclib for patients with a molecular tumor profile that can potentially be targeted by Ribociclib.
|
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.
Other Names:
|
Experimental: Lenvatinib
Lenvatinib for patients with a molecular tumor profile that can potentially be targeted by Lenvatinib.
|
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.
Other Names:
|
Experimental: Pembrolizumab
Pembrolizumab for patients with a molecular tumor profile that can potentially be targeted by Pembrolizumab.
|
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.
Other Names:
|
Experimental: Durvalumab
Durvalumab for patients with a molecular tumor profile that can potentially be targeted by Durvalumab.
|
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.
Other Names:
|
Experimental: Rucaparib
Rucaparib for patients with a molecular tumor profile that can potentially be targeted by Rucaparib.
|
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.
Other Names:
|
Experimental: Palbociclib
Palbociclib for patients with a molecular tumor profile that can potentially be targeted by Palbociclib.
|
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.
Other Names:
|
Experimental: Crizotinib
Crizotinib for patients with a molecular tumor profile that can potentially be targeted by Crizotinib.
|
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.
Other Names:
|
Experimental: Sunitinib
Sunitinib for patients with a molecular tumor profile that can potentially be targeted by Sunitinib.
|
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.
Other Names:
|
Experimental: Cabozantinib
Cabozantinib for patients with a molecular tumor profile that can potentially be targeted by Cabozantinib.
|
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.
Other Names:
|
Experimental: Abemaciclib
Abemaciclib for patients with a molecular tumor profile that can potentially be targeted by Abemaciclib.
|
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.
Other Names:
|
Experimental: Atezolizumab/bevacizumab
Atezolizumab and bevacizumab (combination treatment) for patients with a molecular tumor profile that can potentially be targeted by Atezolizumab and bevacizumab.
|
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.
Other Names:
|
Experimental: Ipilimumab/nivolumab
Ipilimumab and nivolumab (combination treatment) for patients with a molecular tumor profile that can potentially be targeted by Ipilimumab and nivolumab.
|
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.
Other Names:
|
Experimental: Entrectinib
Entrectinib for patients with a molecular tumor profile that can potentially be targeted by entrectinib.
|
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.
Other Names:
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Experimental: Talazoparib
Talazoparib for patients with a molecular tumor profile that can potentially be targeted by talazoparib.
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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.
Other Names:
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Experimental: dacomitinib
Dacomitinib for patients with a molecular tumor profile that can potentially be targeted by dacomitinib.
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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.
Other Names:
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Experimental: Lorlatinib
Lorlatinib for patients with a molecular tumor profile that can potentially be targeted by lorlatinib.
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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.
Other Names:
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Experimental: Erdafitinib
Erdafitinib for patients with a molecular tumor profile that can potentially be targeted by erdafitinib.
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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.
Other Names:
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Experimental: Alpelisib
Alpelisib for patients with a molecular tumor profile that can potentially be targeted by alpelisib.
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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.
Other Names:
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Experimental: Niraparib
Niraparib for patients with a molecular tumor profile that can potentially be targeted by niraparib.
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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.
Other Names:
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Experimental: Pemigatinib
Pemigatinib for patients with a molecular tumor profile that can potentially be targeted by pemigatinib.
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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.
Other Names:
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Experimental: Selpercatinib
Selpercatinib for patients with a molecular tumor profile that can potentially be targeted by selpercatinib.
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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.
Other Names:
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Experimental: Tepotinib
Tepotinib for patients with a molecular tumor profile that can potentially be targeted by tepotinib.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of patients that are treated based on their molecular tumor profile
Time Frame: 6 months after treatment initiation (estimated average)
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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.
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6 months after treatment initiation (estimated average)
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Objective tumor response
Time Frame: 6 months after treatment initiation (estimated average)
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Primary outcome measure 2 is the proportion of study participants with an objective tumor response upon study treatment..
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6 months after treatment initiation (estimated average)
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Stable disease
Time Frame: 6 months after treatment initiation (estimated average)
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Primary outcome measure 3 is the proportion of study participants that has stable disease (SD) during study treatment.
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6 months after treatment initiation (estimated average)
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Treatment-related grade≥3 and serious adverse events
Time Frame: 6 months after treatment initiation (estimated average)
|
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)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-free survival
Time Frame: Up to 1 year after study completion
|
Up to 1 year after study completion
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Overall survival
Time Frame: Up to 1 year after study completion
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Up to 1 year after study completion
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Duration of treatment on study (time on drug)
Time Frame: 6 months after treatment initiation (estimated average)
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6 months after treatment initiation (estimated average)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concordance between pre-treatment and historic mutational tumor profile
Time Frame: 2 months after treatment initiation (estimated average)
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Sequencing results of fresh pre-treatment biopsies will be available within 2 months after treatment initiation.
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2 months after treatment initiation (estimated average)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: E.E. Voest, prof., The Netherlands Cancer Institute
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Poly(ADP-ribose) Polymerase Inhibitors
- Immune Checkpoint Inhibitors
- Trastuzumab
- Olaparib
- Sunitinib
- Nivolumab
- Palbociclib
- Durvalumab
- Bevacizumab
- Pembrolizumab
- Axitinib
- Niraparib
- Rucaparib
- Panitumumab
- Lenvatinib
- Trametinib
- Dabrafenib
- Ipilimumab
- Atezolizumab
- Afatinib
- Pertuzumab
- Vemurafenib
- Crizotinib
- Entrectinib
- Tepotinib
- Talazoparib
Other Study ID Numbers
- M15DRU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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