N-of-1 Trial: Actionable Target Identification in Metastatic Cancer for Palliative Systemic Therapy (MetAction)
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|ClinicalTrials.gov Identifier: NCT02142036|
Recruitment Status : Completed
First Posted : May 20, 2014
Last Update Posted : March 13, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Cancer||Drug: EMA-approved ATI based targeted therapy||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||N-of-1 Trial of Actionable Target Identification in Metastatic Cancer for Palliative Systemic Therapy|
|Actual Study Start Date :||May 2014|
|Actual Primary Completion Date :||August 2018|
|Actual Study Completion Date :||August 2018|
Experimental: ATI based targeted therapy.
EMA-approved ATI based targeted therapy. Patients will receive therapy based on molecular aberrations identified in the metastatic lesion.
Drug: EMA-approved ATI based targeted therapy
All drugs that may be used in the study are approved by EMA for treatment of disseminated cancer in the palliative setting, but not for the particular tumor type in question.
- Progression-free survival (PFS) [ Time Frame: 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.
- Overall response rate (ORR) [ Time Frame: From date of initiation of study treatment until the date of first documented progression, assessed up to 24 months. ]The sum of partial responses (PS) plus complete responses (CR).
- Overall survival (OS) [ Time Frame: From date of initiation of study treatment until date of death, from any cause, assessed up to 24 months. ]
- Overall clinical benefit rate (ORR + stable disease [SD] ≥ 6 months) [ Time Frame: From date of initial response to date of first documented progression, assessed up to 24 months. ]
- ATI rate [ Time Frame: From date of screening of first included patient until date of completion of screening phase, an expected time period of 24 months.. ]
- PFS in ATI lesions only. [ Time Frame: From date of initiation of study treatment until date of first documented progression in ATI lesions, assessed up to 24 months. ]
- Health Related Quality of Life (HRQoL) Questionnaire [ Time Frame: From date of initiation of study treatment until date of end of study visit, an expected average of 4 months. ]Assessed by the subject questionnaire EORTC Quality of Life Questionnaire Core 30 (QlQ-C30) at baseline, every 8 week during treatment and at end of study visit.
- Toxicity grade 3-5 [ Time Frame: From date of initiation of study treatment until date of follow-up visit, an expected average of 5 months. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02142036
|Akershus University Hospital|
|Lillestrøm, Norway, 1478|
|The Norwegian Radium Hospital|
|Oslo, Norway, 0379|
|Study Chair:||Kjersti Flatmark, MD PhD||Oslo University Hospital|
|Principal Investigator:||Svein Dueland, MD||Oslo University Hospital|
|Principal Investigator:||Anne Hansen Ree, Prof. MD PhD||University Hospital, Akershus|