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N-of-1 Trial: Actionable Target Identification in Metastatic Cancer for Palliative Systemic Therapy (MetAction)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02142036
Recruitment Status : Completed
First Posted : May 20, 2014
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
The Research Council of Norway
Information provided by (Responsible Party):
Kjersti Flatmark, Oslo University Hospital

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.


Condition or disease Intervention/treatment Phase
Metastatic Cancer Drug: EMA-approved ATI based targeted therapy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.
Other Names:
  • Cetuximab
  • Panitumumab
  • Gefitinib
  • Erlotinib
  • Crizotinib
  • Trastuzumab
  • Lapatinib
  • Imatinib
  • Dasatinib
  • Nilotinib
  • Vemurafenib
  • Everolimus
  • Temsirolimus
  • Sunitinib
  • Ruxolitinib
  • Vandetanib.
  • Afatinib
  • Dabrafenib




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. Overall survival (OS) [ Time Frame: From date of initiation of study treatment until date of death, from any cause, assessed up to 24 months. ]

Other Outcome Measures:
  1. 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. ]
  2. 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.. ]
  3. 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. ]
  4. 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.

  5. 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. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Norway
Akershus University Hospital
Lillestrøm, Norway, 1478
The Norwegian Radium Hospital
Oslo, Norway, 0379
Sponsors and Collaborators
Oslo University Hospital
The Research Council of Norway
Investigators
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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kjersti Flatmark, National coordinator, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02142036    
Other Study ID Numbers: MetAction
First Posted: May 20, 2014    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Kjersti Flatmark, Oslo University Hospital:
Metastatic disease
Metastasis
Targeted therapy
Solid tumor
Personalized medicine
N-of-1 trial
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes
Trastuzumab
Cetuximab
Panitumumab
Everolimus
Sunitinib
Dasatinib
Lapatinib
Gefitinib
Afatinib
Vemurafenib
Dabrafenib
Crizotinib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors