This is a prospective non-randomized national clinical phase 2 trial that aims to determine the efficacy and toxicity of targeted anticancer drugs or combinations that are approved or under review by EMA, FDA or PMDA and are used for treatment of patients with advanced cancer with a potentially actionable variant as revealed by a genomic, RNA-molecular or protein expression test.
This is a prospective non-randomized clinical trial that aims to determine the efficacy and toxicity of targeted anticancer drugs or combinations that are approved or under review by EMA, FDA or PMDA and are used for treatment of patients with advanced cancer with a potentially actionable variant as revealed by a genomic, RNA-molecular or protein expression test. The study also aims to facilitate patient access to approved targeted therapies that are contributed to the program by collaborating pharmaceutical companies and to perform next generation sequencing and further deeper analysis on tumor biopsies and/or liquid biopsies for biomarker analyses and resistance mechanisms. Eligible patients have an advanced cancer for which standard treatment options no longer exist and acceptable performance status and organ function. A tumour DNA, RNA or protein expression analysis is required and the results must identify at least one potentially actionable molecular variant as defined in the protocol. Molecular profiling will be utilized to determine an appropriate drug(s) from among those available in the protocol. Drug selection will be guided by a list of potential profiles, the molecular tumor board and databases of identified targets for review and approval of the recommended treatment. The protocol-specified treatment will be administered to the patient once any drug- and disease specific eligibility criteria and overall study criteria are met. Data for standard efficacy outcomes including tumor response, progression-free and overall survival as well as duration of treatment will be collected for all patients receiving treatment within the trial. In addition, treatment related toxicity will be collected according to CTCAE 5.0.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
ALK
MEK1, MEK2
Hedgehog
HER2
NTRK/ ROS1, ALK
PD-L1
BRAF V600
KIT/BRAF, RET
AR
CDK4/6
MET ex14
RAF
MEK1, MEK2
RAF, MEK1, MEK2
FGFR2
Turku University Hospital Cancer Centre
Turku, Southwest Finland, Finland
RECRUITINGHelsinki University Hospital Comprehensive Cancer Center
Helsinki, Uusimaa, Finland
RECRUITINGKuopio University Hospital
Kuopio, Finland
RECRUITINGOulu University Hospital OYS Cancer Center
Oulu, Finland
RECRUITINGTampere University Hospital Department of Oncology
Tampere, Finland
RECRUITINGDisease control rate
Disease control rate at 16 weeks after treatment initiation (defined as patients by CR, PR, SD)
Time frame: 16 weeks
Duration of treatment
Time on drug
Time frame: 5 years
Adverse Events
Treatment-related grade ≥3 and serious adverse events
Time frame: 5 years
Overall response
Best overall response (defined as patients by CR, PR, SD)
Time frame: 5 years
PFS
Progression free survival
Time frame: 5 years
OS
Overall survival
Time frame: 5 years
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