A Study of Tarceva (Erlotinib) in First Line in Patients With Locally Advanced or Metastatic Lung Adenocarcinoma With EGFR Mutations
NCT ID: NCT01609543
Last Updated: 2016-02-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
62 participants
INTERVENTIONAL
2012-05-31
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm
erlotinib [Tarceva]
150 mg orally daily, until disease progression, unacceptable toxicity or withdrawal due to any reason
Interventions
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erlotinib [Tarceva]
150 mg orally daily, until disease progression, unacceptable toxicity or withdrawal due to any reason
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically documented, inoperable, locally advanced, recurrent or metastatic (Stage IIIB or Stage IV) lung adenocarcinoma
* Non-small cell lung cancer with an EGFR activating mutation
* Patients must have evidence of disease, but measurable disease is not mandatory
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Adequate renal and liver function
Exclusion Criteria
* Prior therapy with systemic anti-tumour therapy with HER1/EGFR inhibitors
* Any other malignancies within 5 years, except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin carcinoma
* Brain metastasis or spinal cord compression not yet definitely treated with surgery and/or radiation
* Patients unable to take oral medication or requiring intravenous alimentation, with prior surgical procedures affecting absorption or active peptic ulcer disease
* Any significant ophthalmologic abnormality, especially those likely to increase the risk of corneal epithelial lesions; the use of contact lenses is not recommended during the study
* Pregnant or breast-feeding women
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Deszk, , Hungary
Farkasgyepű, , Hungary
Gyula, , Hungary
Mátraháza, , Hungary
Mosonmagyaróvar, , Hungary
Nyíregyháza, , Hungary
Pécs, , Hungary
Szekszárd, , Hungary
Székesfehérvár, , Hungary
Szolnok, , Hungary
Szombathely, , Hungary
Törökbálint, , Hungary
Törökbálint, , Hungary
Riga, , Latvia
Riga, , Latvia
Ankara, , Turkey (Türkiye)
Ankara, , Turkey (Türkiye)
Antalya, , Turkey (Türkiye)
Edirne, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Countries
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References
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Markoczy Z, Sarosi V, Kudaba I, Galffy G, Turay UY, Demirkazik A, Purkalne G, Somfay A, Papai-Szekely Z, Raso E, Ostoros G. Erlotinib as single agent first line treatment in locally advanced or metastatic activating EGFR mutation-positive lung adenocarcinoma (CEETAC): an open-label, non-randomized, multicenter, phase IV clinical trial. BMC Cancer. 2018 May 25;18(1):598. doi: 10.1186/s12885-018-4283-z.
Other Identifiers
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2011-002168-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ML27880
Identifier Type: -
Identifier Source: org_study_id
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