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Brief Title: N-of-1 Trial: Actionable Target Identification in Metastatic Cancer for Palliative Systemic Therapy
Official Title: N-of-1 Trial of Actionable Target Identification in Metastatic Cancer for Palliative Systemic Therapy
Study ID: NCT02142036
Brief Summary: The metastatic lesions may be very different from the primary tumor because of intrinsic tumor heterogenity, clonal selection through metastatic process and following previous cytotoxic treatments. Metastatic tumor harboring actionable targets or signaling pathways may respond to inhibitory agents directed against specific aberrations irrespective of tumor origin. In the MetAction study, patients will receive therapy based on molecular aberrations in the metastatic lesions, actionable target identification (ATI), rather than on histological tumor type. The ATI rate in an unselected metastatic patient population is uncertain, and response rates associated with ATI based targeted therapy have hardly been reported. In this perspective, The MetAction study is essentially a feasibility study aiming to tailor metastatic cancer therapy based on genomic profiles.
Detailed Description: Recognizing the rapidly increasing number of drugs targeting specific molecular aberrations in cancer, it is necessary to define rational strategies to make such treatment available to Norwegian cancer patients.These targeted drugs are extremely costly and have significant side effects, although presumably to a lesser extent than many of the classic cytotoxic drugs available. Thus, in the interest of the patient in question and the society in general, it is important to give the right drug to the right patient and to the presumably right time in the disease course. Hitherto, most of the drugs in question are given in the palliative setting, i.e. to patients with disseminated metastatic disease. The metastatic lesion may be very different from the primary tumor, and hence, it is rational to analyze the tumor to be treated, the metastatic lesion(s), for the presence of molecular aberrations, rather than basing treatment decisions on molecular features known to be present in a particular tumor type or in the primary tumor.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Akershus University Hospital, Lillestrøm, , Norway
The Norwegian Radium Hospital, Oslo, , Norway
Name: Kjersti Flatmark, MD PhD
Affiliation: Oslo University Hospital
Role: STUDY_CHAIR
Name: Svein Dueland, MD
Affiliation: Oslo University Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Anne Hansen Ree, Prof. MD PhD
Affiliation: University Hospital, Akershus
Role: PRINCIPAL_INVESTIGATOR