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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2014

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2014

Completed
18 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 20, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

4.3 years

First QC Date

April 13, 2014

Last Update Submit

March 12, 2019

Conditions

Metastatic Cancer

Keywords

Metastatic diseaseMetastasisTargeted therapySolid tumorPersonalized medicineN-of-1 trial

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival (PFS)

    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.

    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.

Secondary Outcomes (2)

  • Overall response rate (ORR)

    From date of initiation of study treatment until the date of first documented progression, assessed up to 24 months.

  • Overall survival (OS)

    From date of initiation of study treatment until date of death, from any cause, assessed up to 24 months.

Other Outcomes (5)

  • Overall clinical benefit rate (ORR + stable disease [SD] ≥ 6 months)

    From date of initial response to date of first documented progression, assessed up to 24 months.

  • ATI rate

    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.

    From date of initiation of study treatment until date of first documented progression in ATI lesions, assessed up to 24 months.

  • +2 more other outcomes

Study Arms (1)

ATI based targeted therapy.

EXPERIMENTAL

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

Interventions

EMA-approved ATI based targeted therapyDRUG

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.

Also known as: Cetuximab, Panitumumab, Gefitinib, Erlotinib, Crizotinib, Trastuzumab, Lapatinib, Imatinib, Dasatinib, Nilotinib, Vemurafenib, Everolimus, Temsirolimus, Sunitinib, Ruxolitinib, Vandetanib., Afatinib, Dabrafenib
ATI based targeted therapy.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Akershus University Hospital

Lillestrøm, 1478, Norway

Location

The Norwegian Radium Hospital

Oslo, 0379, Norway

Location

Related Publications (2)

  • Ree 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: 35943168DERIVED

  • Ree 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: 32208873DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

CetuximabPanitumumabGefitinibErlotinib HydrochlorideCrizotinibTrastuzumabLapatinibImatinib MesylateDasatinibnilotinibVemurafenibEverolimustemsirolimusSunitinibruxolitinibvandetanibAfatinibdabrafenib

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsQuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPiperidinesHeterocyclic Compounds, 1-RingAminopyridinesPyridinesBenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesPyrimidinesThiazolesSulfur CompoundsAzolesSulfonamidesSulfonesIndolesSirolimusMacrolidesLactonesPyrroles

Study Officials

  • Kjersti Flatmark, MD PhD

    Oslo University Hospital

    STUDY CHAIR

  • Svein Dueland, MD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

  • Anne Hansen Ree, Prof. MD PhD

    University Hospital, Akershus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
National coordinator

Study Record Dates

First Submitted

April 13, 2014

First Posted

May 20, 2014

Study Start

May 1, 2014

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

March 13, 2019

Record last verified: 2019-03

Locations

NO(2)