Clinical trial · Interventional
N-of-1 Trial: Actionable Target Identification in Metastatic Cancer for Palliative Systemic Therapy
N-of-1 Trial of Actionable Target Identification in Metastatic Cancer for Palliative Systemic Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EMA-approved ATI based targeted therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ATI based targeted therapy.
- description
- EMA-approved ATI based targeted therapy. Patients will receive therapy based on molecular aberrations identified in the metastatic lesion.
- interventionNames
- Drug: EMA-approved ATI based targeted therapy
Primary outcomes (1)
- measure
- Progression-free survival (PFS)
- timeFrame
- 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.
- description
- 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.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Metastatic cancer and progression by RECIST 1.0 evaluated by internal review on at least one prior regimen of established palliative systemic therapies for advanced disease and eligibility for repeat biopsy sampling. The patient must have received ≥6 weeks of the previous treatment. Only patients who have no other standard treatment option or were the treatment option is considered to offer the patients only minor benefit may be included in the study. * Radiological evaluation intervals on last prior therapy (period A) must have been 6 to 12 weeks. * At least one measurable lesions (\>10mm on CT-scan) according to RECIST 1.0. * Age ≥ 18 years. Eastern Cooperative Oncology Group (ECOG) performance status 1 or lower. * Life expectancy of more than 3 months. * Adequate bone marrow function without current use of colony-stimulating factors: Neutrophils ≥1.5 x109/l; Platelets ≥100 x109/l; Hb \>10 g/dl, INR within normal level. * Adequate liver function: AST/ALT ≤5x ULN; Bilirubin ≤2x ULN, albumin \>30 g/l. * Adequate renal function: Creatinine ≤1.5x ULN. * Be able to use recommended dose of the selected targeted therapy as described in the drug specific SPC. * Be able to comply with the protocol. * Fertile men and women must be willing to use effective contraceptives. * Provide written (signed) informed consent to participate in the trial prior to any trial specific screening procedures. Exclusion Criteria: * Metastatic disease from more than one malignancy. * Untreated or symptomatic brain metastasis (patients must be symptom-free without the use of corticosteroids). * Any reason why, in the opinion of the investigator, the patient should not participate. * Pregnancy. * Breastfeeding * Anticoagulation with coumarin derivatives. * Radiation therapy within 4 weeks of start of treatment. * Need to use medications contraindicated according to SPC of the different drugs.
References
Publications (2)
- DERIVEDRee AH, Maelandsmo GM, Flatmark K, Russnes HG, Gomez Castaneda M, Aas E. Cost-effectiveness of molecularly matched off-label therapies for end-stage cancer - the MetAction precision medicine study. Acta Oncol. 2022 Aug;61(8):955-962. doi: 10.1080/0284186X.2022.2098053. Epub 2022 Aug 9. PMID 35943168
- DERIVEDRee AH, Nygaard V, Boye K, Heinrich D, Dueland S, Bergheim IR, Johansen C, Beiske K, Negard A, Lund-Iversen M, Nygaard V, Hovig E, Nakken S, Nasser S, Julsrud L, Reisse CH, Ruud EA, Kristensen VN, Florenes VA, Geitvik GA, Lingjaerde OC, Borresen-Dale AL, Russnes HG, Maelandsmo GM, Flatmark K. Molecularly matched therapy in the context of sensitivity, resistance, and safety; patient outcomes in end-stage cancer - the MetAction study. Acta Oncol. 2020 Jul;59(7):733-740. doi: 10.1080/0284186X.2020.1742377. Epub 2020 Mar 25. PMID 32208873