The Drug Rediscovery Protocol (DRUP Trial)

Sponsor
The Netherlands Cancer Institute
Study ID
NCT02925234
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cancer
  • Neoplasia
  • Neoplasm
  • Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Aug 31, 2016
Status verified
Jan 2024
Primary completion
Sep 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
1,550 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Panitumumab
    Panitumumab for patients with a molecular tumor profile that can potentially be targeted by Panitumumab.
  • Experimental: Olaparib
    Olaparib for patients with a molecular tumor profile that can potentially be targeted by Olaparib.
  • Experimental: Dabrafenib
    Dabrafenib for patients with a molecular tumor profile that can potentially be targeted by Dabrafenib.
  • Experimental: Nilotinib
    Nilotinib for patients with a molecular tumor profile that can potentially be targeted by nilotinib.
  • Experimental: Trametinib
    Trametinib for patients with a molecular tumor profile that can potentially be targeted by trametinib.
  • Experimental: Erlotinib
    Erlotinib for patients with a molecular tumor profile that can potentially be targeted by erlotinib.
  • 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.
  • 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.
  • Experimental: Vismodegib
    Vismodegib for patients with a molecular tumor profile that can potentially be targeted by vismodegib.
  • Experimental: Regorafenib
    Regorafenib for patients with a molecular tumor profile that can potentially be targeted by regorafenib.
  • Experimental: Nivolumab
    Nivolumab for patients with a molecular tumor profile that can potentially be targeted by nivolumab.
  • Experimental: Afatinib
    Afatinib for patients with a molecular tumor profile that can potentially be targeted by Afatinib.
  • 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.
  • Experimental: Ribociclib
    Ribociclib for patients with a molecular tumor profile that can potentially be targeted by Ribociclib.
  • Experimental: Lenvatinib
    Lenvatinib for patients with a molecular tumor profile that can potentially be targeted by Lenvatinib.
  • Experimental: Pembrolizumab
    Pembrolizumab for patients with a molecular tumor profile that can potentially be targeted by Pembrolizumab.
  • Experimental: Durvalumab
    Durvalumab for patients with a molecular tumor profile that can potentially be targeted by Durvalumab.
  • Experimental: Rucaparib
    Rucaparib for patients with a molecular tumor profile that can potentially be targeted by Rucaparib.
  • Experimental: Axitinib
    Axitinib for patients with a molecular tumor profile that can potentially be targeted by Axitinib.
  • Experimental: Palbociclib
    Palbociclib for patients with a molecular tumor profile that can potentially be targeted by Palbociclib.
  • Experimental: Crizotinib
    Crizotinib for patients with a molecular tumor profile that can potentially be targeted by Crizotinib.
  • Experimental: Sunitinib
    Sunitinib for patients with a molecular tumor profile that can potentially be targeted by Sunitinib.
  • Experimental: Cabozantinib
    Cabozantinib for patients with a molecular tumor profile that can potentially be targeted by Cabozantinib.
  • Experimental: Abemaciclib
    Abemaciclib for patients with a molecular tumor profile that can potentially be targeted by Abemaciclib.
  • Experimental: Alectinib
    Alectinib for patients with a molecular tumor profile that can potentially be targeted by Alectinib.
  • Experimental: Atezolizumab/bevacizumab
    Atezolizumab and bevacizumab (combination treatment) for patients with a molecular tumor profile that can potentially be targeted by Atezolizumab and bevacizumab.
  • Experimental: Ipilimumab/nivolumab
    Ipilimumab and nivolumab (combination treatment) for patients with a molecular tumor profile that can potentially be targeted by Ipilimumab and nivolumab.
  • Experimental: Entrectinib
    Entrectinib for patients with a molecular tumor profile that can potentially be targeted by entrectinib.
  • Experimental: Talazoparib
    Talazoparib for patients with a molecular tumor profile that can potentially be targeted by talazoparib.
  • Experimental: dacomitinib
    Dacomitinib for patients with a molecular tumor profile that can potentially be targeted by dacomitinib.
  • Experimental: Lorlatinib
    Lorlatinib for patients with a molecular tumor profile that can potentially be targeted by lorlatinib.
  • Experimental: Erdafitinib
    Erdafitinib for patients with a molecular tumor profile that can potentially be targeted by erdafitinib.
  • Experimental: Alpelisib
    Alpelisib for patients with a molecular tumor profile that can potentially be targeted by alpelisib.
  • Experimental: Niraparib
    Niraparib for patients with a molecular tumor profile that can potentially be targeted by niraparib.
  • Experimental: Pemigatinib
    Pemigatinib for patients with a molecular tumor profile that can potentially be targeted by pemigatinib.
  • Experimental: Selpercatinib
    Selpercatinib for patients with a molecular tumor profile that can potentially be targeted by selpercatinib.
  • Experimental: Tepotinib
    Tepotinib for patients with a molecular tumor profile that can potentially be targeted by tepotinib.

Primary Outcome Measure

Percentage of patients that are treated based on their molecular tumor profile [ Time Frame: 6 months after treatment initiation (estimated average) ]

Central Contacts

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