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N-of-1 Trial of Actionable Target Identification in Metastatic Cancer for Palliative Systemic Therapy (MetAction)
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.
Details
| Lead sponsor | Oslo University Hospital |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 50 |
| Start date | 2014-05 |
| Completion | 2018-08 |
Conditions
- Metastatic Cancer
Interventions
- EMA-approved ATI based targeted therapy
Primary outcomes
- Progression-free survival (PFS) — From date of initiation of study treatment until the date of first documented progression or date of death, from any cause, whichever came first, assessed up to 24 months.
Comparing the PFS using therapy selected by ATI in a patient's tumor (period B) with the PFS for the most recent therapy on which the patient had just experienced progression (period A). The ATI-selected therapy is defined as having benefit for the patient if PFS period B/PFS in period A ratio is ≥ 1.3.
Countries
Norway