Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022509-17 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This single arm, open-label study will evaluate the efficacy and safety of erlotinib (Tarceva) in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erlotinib | Experimental | Participants will receive erlotinib 150 millgrams (mg) orally daily until disease progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erlotinib | Drug | Erlotinib 150 mg tablet will be given orally daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Objective Response (Complete Response [CR]/Partial Response [PR]) Based on Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | Objective response (OR) was based on criteria related to changes in size of target lesions according to modified RECIST. Target lesions were selected on the basis of their size (lesions with the longest diameter) as well as the feasibility of reproducible repeated measurements. OR was the sum of complete response (CR) and partial response (PR) four at least 4 weeks during treatment. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | Baseline up to 5 years (assessed at Baseline, every 8 weeks until disease progression or death or end of treatment period [up to 5 years]) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) Based on CT or MRI According to RECIST v 1.1 | Kaplan Meier estimate of the median PFS was defined as the time at which half of the participants have progressed (progressive disease [PD]) based on RECIST tumor response criteria or died from any cause, whichever occurred first. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Patients who had not died or progressed at the time of the final analysis were censored at the date of last contact. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Infante D. Pedro; Servico de Oncologia Medica | Aveiro | 3814-501 | Portugal | |||
| Hospital Geral; Servico de Pneumologia |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Erlotinib | Participants received erlotinib 150 millgrams (mg) orally daily until disease progression. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 28, 2014 | Sep 26, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline up to 5 years (assessed at Baseline, every 8 weeks until disease progression or death or end of treatment period [up to 5 years]) |
| Overall Survival | Overall Survival (OS) was defined as the time between the date of randomization and the date of death due to any cause. | Baseline up to 5 years |
| Percentage of Participants With Adverse Events | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Baseline up to 5 years |
| Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Mutation in Study Population | Mutations in the EGFR included exon 19 deletion mutations and the single-point substitution mutation L858R in exon 21. | Screening (21 days prior to Day 1) |
| Median Time Taken From the First Response Until Disease Progression Based on RECIST v 1.1 as Determined by the Investigator | The response duration was defined as the time of initial response (complete response (CR) /partial response (PR) whichever is first recorded) until documented disease progression. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression was defined as At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). | Baseline up to 5 years (assessed at Baseline, every 8 weeks until disease progression or death or end of treatment period [up to 5 years]) |
| Coimbra |
| 3041-801 |
| Portugal |
| IPO de Lisboa; Servico de Pneumologia | Lisbon | 1099-023 | Portugal |
| Hospital Santo Antonio dos Capuchos;Servico de Oncologia Medica | Lisbon | 1150-314 | Portugal |
| Hospital de Santa Maria; Servico de Pneumologia | Lisbon | 1600 | Portugal |
| Hospital Pulido Valente; Servico de Pneumologia | Lisbon | 1796-001 | Portugal |
| IPO do Porto; Servico de Oncologia Medica | Porto | 4200-072 | Portugal |
| Hospital de Sao Joao; Servico de Pneumologia | Porto | 4200 | Portugal |
| CHVNG/E_Unidade 1; Servico de Pneumologia | Vila Nova de Gaia | 4434-502 | Portugal |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The intention to treat (ITT) population was defined as all subjects who are enrolled to the treatment phase of the study, regardless if they completed treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Erlotinib | Participants received erlotinib 150 millgrams (mg) orally daily until disease progression. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Objective Response (Complete Response [CR]/Partial Response [PR]) Based on Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | Objective response (OR) was based on criteria related to changes in size of target lesions according to modified RECIST. Target lesions were selected on the basis of their size (lesions with the longest diameter) as well as the feasibility of reproducible repeated measurements. OR was the sum of complete response (CR) and partial response (PR) four at least 4 weeks during treatment. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | The ITT population was defined as all subjects who are enrolled to the treatment phase of the study, regardless if they completed treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 5 years (assessed at Baseline, every 8 weeks until disease progression or death or end of treatment period [up to 5 years]) |
|
|
| |||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) Based on CT or MRI According to RECIST v 1.1 | Kaplan Meier estimate of the median PFS was defined as the time at which half of the participants have progressed (progressive disease [PD]) based on RECIST tumor response criteria or died from any cause, whichever occurred first. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Patients who had not died or progressed at the time of the final analysis were censored at the date of last contact. | The ITT population was defined as all subjects who are enrolled to the treatment phase of the study, regardless if they completed treatment. | Posted | Median | 95% Confidence Interval | weeks | Baseline up to 5 years (assessed at Baseline, every 8 weeks until disease progression or death or end of treatment period [up to 5 years]) |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall Survival (OS) was defined as the time between the date of randomization and the date of death due to any cause. | The ITT population was defined as all subjects who are enrolled to the treatment phase of the study, regardless if they completed treatment. | Posted | Median | 95% Confidence Interval | weeks | Baseline up to 5 years |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | The safety population was identical to the ITT population, which included all participants enrolled in the study. | Posted | Number | percentage of participants | Baseline up to 5 years |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Mutation in Study Population | Mutations in the EGFR included exon 19 deletion mutations and the single-point substitution mutation L858R in exon 21. | The ITT population was defined as all subjects who are enrolled to the treatment phase of the study, regardless if they completed treatment. | Posted | Number | percentage of participants | Screening (21 days prior to Day 1) |
|
| |||||||||||||||||||||||||||
| Secondary | Median Time Taken From the First Response Until Disease Progression Based on RECIST v 1.1 as Determined by the Investigator | The response duration was defined as the time of initial response (complete response (CR) /partial response (PR) whichever is first recorded) until documented disease progression. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression was defined as At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). | The ITT population was defined as all subjects who are enrolled to the treatment phase of the study, regardless if they completed treatment. | Posted | Median | 95% Confidence Interval | weeks | Baseline up to 5 years (assessed at Baseline, every 8 weeks until disease progression or death or end of treatment period [up to 5 years]) |
|
|
5 years
The safety population was identical to the ITT population, which included all participants enrolled in the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Erlotinib | Participants received erlotinib 150 millgrams (mg) orally daily until disease progression. | 4 | 30 | 8 | 30 | 29 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Intestinal Perforation | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA, version 21.0 | Systematic Assessment |
| |
| Pelvic Infection | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA, version 21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dermatitis Acneiform | Skin and subcutaneous tissue disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Eye Infection | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Dry Eye | Eye disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Neutrophil Count Increased | Investigations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA, version 21.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA, version 21.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA, version 21.0 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Feb 12, 2014 | Sep 26, 2018 | Prot_001.pdf |
| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
|
|