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This 3 arm study will compare the efficacy and safety of three different dermatological creams designed for prophylaxis of skin rash associated with Tarceva treatment in patients with locally advanced or metastatic non-small cell lung cancer. Eligible patients who have recently started Tarceva treatment will be randomized to one of 3 groups, to receive daily treatment with Verutex, Eritex or Fisiogel cream for 30 days, and the incidence and severity of skin rash will be assessed. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| erlotinib [Tarceva] | Drug | 150mg po daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Develop Skin Rash | Skin rash was assessed by the investigator and dermatologists (the latter ones only through pictures) and scored according to (National cancer Institute -Common Terminology Criteria for Adverse Events ) NCI-CTCAE ( version 3 (line "Rash/desquamation" - short name "rash"). | 30 Days |
| Percentage of Participants With Skin Rash Stratified by Severity Grade | The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Appearance of Skin Rash | Time to occurence of skin rash was calculated as the number of days from Day 0 until the first appearance of skin rash as defined by NCI-CTCAE | Days 0, 15, and 30 |
| Percentage of Participants With Erythema |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortaleza | Ceará | 60125-151 | Brazil | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Fisiogel | Participants received erlotinib 150 milligrams (mg) daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. |
| FG001 | Stiemicyn |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| fusidic acid [Verutex] |
| Drug |
topical, daily for 30 days. |
|
| erythromycin [Eritex] | Drug | topical, daily for 30 days. |
|
| Fisiogel | Drug | topical, daily for 30 days |
|
Erythema is defined as redness of the skin or mucous membranes, caused by hyperemia of superficial capillaries
| Days 0, 15, and 30 |
| Percentage of Participants With Pruritus | Pruritus is defined as intense localized itching | Days 0, 15, and 30 |
| Percentage of Participants With Pain | Pain is defined as an unpleasant feeling often caused by intense or damaging stimuli | Days 0, 15, and 30 |
| Percentage of Participants With Erythema Stratified by Severity Grade | The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist. | 30 Days |
| Percentage of Participants With Pruritus Stratified by Severity Grade | The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist. | 30 Days |
| Percentage of Participants With Pain Stratified by Severity Grade | The severity of pain was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist. | 30 Days |
| Fortaleza |
| Ceará |
| 60190-800 |
| Brazil |
| Salvador | Estado de Bahia | 40110-150 | Brazil |
| Salvador | Estado de Bahia | 40170-110 | Brazil |
| Salvador | Estado de Bahia | 41950-610 | Brazil |
| Taguatinga | Federal District | 72115-700 | Brazil |
| Goiânia | Goiás | 74140-050 | Brazil |
| Belo Horizonte | Minas Gerais | 30150-281 | Brazil |
| Belo Horizonte | Minas Gerais | 30150-321 | Brazil |
| Divinópolis | Minas Gerais | 35500-222 | Brazil |
| Curitiba | Paraná | 80010030 | Brazil |
| Curitiba | Paraná | 80810-050 | Brazil |
| Recife | Pernambuco | 50070-170 | Brazil |
| Rio de Janeiro | Rio de Janeiro | 22260-020 | Brazil |
| Rio de Janeiro | Rio de Janeiro | 22290-160 | Brazil |
| Natal | Rio Grande do Norte | 59040150 | Brazil |
| Ijuà | Rio Grande do Sul | 98700-000 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90430-090 | Brazil |
| Itajaà | Santa Catarina | 88301-220 | Brazil |
| Ribeirão Preto | São Paulo | 14025-270 | Brazil |
| São Paulo | São Paulo | 01221-020 | Brazil |
| São Paulo | São Paulo | 01308-000 | Brazil |
| São Paulo | São Paulo | 01323-000 | Brazil |
| São Paulo | São Paulo | 01406100 | Brazil |
| São Paulo | São Paulo | 04039-901 | Brazil |
| São Paulo | São Paulo | 05652-000 | Brazil |
Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. |
| FG002 | Verutex | Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intention to treat (ITT) population covered all participants who had at least one application of study drug and who had at least one post-treatment assessment, irrespective of compliance extent with protocol criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | Fisiogel | Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. |
| BG001 | Stiemicyn | Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. |
| BG002 | Verutex | Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. |
| BG003 | Total | Total of all reporting groups |
| 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 |
|
| 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 Who Develop Skin Rash | Skin rash was assessed by the investigator and dermatologists (the latter ones only through pictures) and scored according to (National cancer Institute -Common Terminology Criteria for Adverse Events ) NCI-CTCAE ( version 3 (line "Rash/desquamation" - short name "rash"). | ITT Population | Posted | Number | 95% Confidence Interval | percentage of participants | 30 Days |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Skin Rash Stratified by Severity Grade | The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death | ITT Population | Posted | Number | percentage of participants | 30 Days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Appearance of Skin Rash | Time to occurence of skin rash was calculated as the number of days from Day 0 until the first appearance of skin rash as defined by NCI-CTCAE | ITT Population | Posted | Median | 95% Confidence Interval | Days | Days 0, 15, and 30 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Erythema | Erythema is defined as redness of the skin or mucous membranes, caused by hyperemia of superficial capillaries | ITT Population | Posted | Number | 95% Confidence Interval | percentage of participants | Days 0, 15, and 30 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Pruritus | Pruritus is defined as intense localized itching | ITT Population | Posted | Number | 95% Confidence Interval | percentage of participants | Days 0, 15, and 30 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Pain | Pain is defined as an unpleasant feeling often caused by intense or damaging stimuli | ITT Population | Posted | Number | 95% Confidence Interval | percentage of participants | Days 0, 15, and 30 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Erythema Stratified by Severity Grade | The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist. | ITT Population | Posted | Number | percentage of participants | 30 Days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Pruritus Stratified by Severity Grade | The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist. | ITT Population | Posted | Number | percentage of participants | 30 Days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Pain Stratified by Severity Grade | The severity of pain was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist. | ITT Population | Posted | Number | percentage of participants | 30 Days |
|
Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fisiogel | Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. | 12 | 67 | 45 | 67 | ||
| EG001 | Stiemicyn | Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. | 13 | 66 | 45 | 66 | ||
| EG002 | Verutex | Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days | 19 | 67 | 48 | 67 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue (asthenia, lethargy, malaise | General disorders | MedDRA | Non-systematic Assessment |
| |
| Pericardial effusion (non-malignant) | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Fever (in the absence of neutropenia, where neurtropenia is defined as ANC <1.0x109/L) | General disorders | MedDRA | Non-systematic Assessment |
| |
| No specification | General disorders | MedDRA | Non-systematic Assessment |
| |
| Death not associated with CTCAE term | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Death not associated with CTCAE term - "cardiac arrest" | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Ascites (non-malignant) | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Obstruction, GI - small bowel NOS | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| No specification | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Hemorrhage, pulmonary/upper respiratory, bronchopulmonary NOS | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Hemorrhage, GI, lower GI NOS | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Hemorrhage, GI, stomach | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Hemorrhage, pulmonary/upper respiratory, respiratory tract NOS | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Lung (pneumonia) | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pulmonary/upper respiratory | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| CNS cerebrovascular ischemia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Confusion | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| No specification, pulmonary/upper respiratory, pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| No specification, cardiovascular, pain | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| No specification | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Disease progression NOS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Vessel injury - vein - SVC | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Mucositis/stomatitis (clinical exam) - oral cavity | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Mucositis/stomatitis (functional/symptomatic) - oral cavity | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| No specification | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dry mouth/salivary gland (xerostomia) | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| No specification | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Fatigue (asthenia, lethargy, malaise) | General disorders | MedDRA | Non-systematic Assessment |
| |
| Fever | General disorders | MedDRA | Non-systematic Assessment |
| |
| No specification | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Nail change | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Lung (pneumonia) | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pulmonary/upper respiratory | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Renal/genitourinary | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| No specification | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| No specification | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| No specification | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| No specification | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| No specification | General disorders | MedDRA | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Death not associated with CTCAE term | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Dry eye syndrome | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| No specification | Musculoskeletal and connective tissue disorders | MedDRA | Non-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 after the first publication or presentation that involves the overall study. 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- LaRoche | 1-800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| D005672 | Fusidic Acid |
| D004917 | Erythromycin |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002775 | Cholestadienols |
| D002774 | Cholestadienes |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Male |
|
Test for Binomial Ratio, where H0: P >=61%; Ha: P < 61% (One-tailed Test) |
| No |
| Superiority or Other |
| t-test, 1 sided | 0.986 | Test for Binomial Ratio, where H0: P >=61%; Ha: P < 61% (One-tailed Test) | No | Superiority or Other |
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