A Study of Tarceva (Erlotinib) in Patients With Locally Advanced, Metastatic or Recurrent Non-Small Cell Cancer Who Present Epidermal Growth Factor Receptor Mutations
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|ClinicalTrials.gov Identifier: NCT01372384|
Recruitment Status : Completed
First Posted : June 13, 2011
Results First Posted : November 16, 2015
Last Update Posted : February 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Non-Squamous Non-Small Cell Lung Cancer||Drug: erlotinib [Tarceva]||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II, Open-label Study of Erlotinib (Tarceva®) Treatment in Patients With Locally Advanced, Metastatic or Recurrent Non-small Cell Lung Cancer Who Present Activating Mutations in the Tyrosine Kinase Domain of the Epidermal Growth Factor Receptor|
|Study Start Date :||January 2012|
|Primary Completion Date :||January 2014|
|Study Completion Date :||January 2014|
|Experimental: Single Arm||
Drug: erlotinib [Tarceva]
150 mg orally daily
- Progression-free Survival (Tumour Assessments According to RECIST Criteria) [ Time Frame: Until participants had disease progression, unacceptable toxicity or died; approximately 24 months. ]Progression free survival is (PFS) defined as the time from the first dose of Erlotinib to the date of first occurrence of disease progression or death.
- Objective Response Rate (Investigator Assessed) [ Time Frame: Visit 4, Visit 6, Visit 10 and Visit 22; (up to approximately 24 months) ]Objective response rate (ORR) was defined by RECIST criteria: Partial response (PR) was defined as ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) was defined as disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression of disease (PD) = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions. Stable Disease (SD) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on the study.
- Safety: Incidence of Adverse Events [ Time Frame: Until participants had disease progression, unacceptable toxicity, or died; approximately 24 months. ]An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An SAE is any experience that suggests a significant hazard, contraindication, side effect, or precaution.
- Overall Survival [ Time Frame: Until participants had disease progression, unacceptable toxicity, or died; approximately 24 months. ]The overall survival (OS) is defined as the time from the first dose of Erlotinib to the date of death due to any cause.
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): NCT01372384
|Plovdiv, Bulgaria, 4004|
|Sofia, Bulgaria, 1404|
|Sofia, Bulgaria, 1431|
|Sofia, Bulgaria, 1527|
|Sofia, Bulgaria, 1756|
|Stara Zagora, Bulgaria, 8000|
|Varna, Bulgaria, 9002|
|Varna, Bulgaria, 9010|
|Veliko Tarnovo, Bulgaria, 5000|
|Study Director:||Clinical Trials||Hoffmann-La Roche|