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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-002895-32 | EudraCT Number |
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This study will evaluate the efficacy and safety of metronidazole actavis 1 percent (%) topical cream in the prevention and treatment of rash associated with Tarceva treatment, in participants with non-small cell lung cancer. The first cohort of participants enrolled in the study will be treated twice daily with metronidazole cream on the right side of the face and upper thorax, the same day as they start treatment with Tarceva (150 mg orally daily). The corresponding body parts on the left side will be treated according to local standard procedures (ie, with non-active moisturizing cream). The second cohort of Tarceva-treated participants will only receive twice daily treatment with metronidazole cream if and when they develop rash. In both cohorts, efficacy will be evaluated at Week 2 and Week 4. The anticipated time on metronidazole treatment is less than (<) 3 months, and the target sample size is <100 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prevention (Erlotinib + Metronidazole Actavis) | Experimental | Participants will receive erlotinib orally daily. Metronidazole actavis treatment will be initiated at the same day as the start of erlotinib. Metronidazole actavis 1% topical cream will be applied on the right side of the face and chest twice daily for 4 weeks. Left side of the face and chest will be treated according to local standard procedures (ie, with non-active moisturizing cream). |
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| Treatment (Erlotinib + Metronidazole Actavis) | Experimental | Participants will receive erlotinib orally daily. Metronidazole actavis treatment will be initiated when participants develop rash. Metronidazole actavis 1% topical cream will be applied on the right side of the face and chest twice daily for 4 weeks. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erlotinib | Drug | Participants will receive erlotinib 150 milligrams (mg) orally daily for 4 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Severity of the rash was evaluated semi-quantitatively using the scale of Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0). Grade 0: no rash; Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening or disabling; Grade 5: Death related to rash. Same participant may be counted in more than one reported categories. | After 2 weeks of metronidazole treatment |
| Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Severity of the rash was evaluated semi-quantitatively using the scale of CTCAE v3.0. Grade 0: no rash; Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening or disabling; Grade 5: Death related to rash. Same participant may be counted in more than one reported categories. | After 4 weeks of metronidazole treatment |
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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 |
|---|---|---|---|---|---|---|
| Gothenburg | 41345 | Sweden | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Prevention (Erlotinib + Metronidazole Actavis) | Participants received erlotinib 150 milligrams (mg) orally daily. Metronidazole actavis treatment was initiated the same day as the start of erlotinib. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the prevention of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Metronidazole Actavis | Drug | Metronidazole actavis 1% topical cream will be applied on the face and chest twice daily for 4 weeks. |
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| Non-active Moisturizing Cream | Other | Left side of the face and chest will be treated according to local standard procedures (ie, with non-active moisturizing cream). |
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| Lund |
| 22185 |
| Sweden |
| Malmö | 20502 | Sweden |
| Stockholm | S-14186 | Sweden |
| Umeå | S-901 85 | Sweden |
| Vaxjo | 35185 | Sweden |
| FG001 | Treatment (Erlotinib + Metronidazole Actavis) | Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the treatment of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream). |
| COMPLETED |
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| NOT COMPLETED |
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All enrolled participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Prevention (Erlotinib + Metronidazole Actavis) | Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated the same day as the start of erlotinib. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the prevention of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream). |
| BG001 | Treatment (Erlotinib + Metronidazole Actavis) | Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the treatment of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 Erlotinib Associated Rash Stratified by Severity Grade at Week 2 | Severity of the rash was evaluated semi-quantitatively using the scale of Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0). Grade 0: no rash; Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening or disabling; Grade 5: Death related to rash. Same participant may be counted in more than one reported categories. | All enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome in respective arms. | Posted | Number | percentage of participants | After 2 weeks of metronidazole treatment |
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| Primary | Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 | Severity of the rash was evaluated semi-quantitatively using the scale of CTCAE v3.0. Grade 0: no rash; Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening or disabling; Grade 5: Death related to rash. Same participant may be counted in more than one reported categories. | All enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome in respective arms. | Posted | Number | percentage of participants | After 4 weeks of metronidazole treatment |
|
Baseline to Week 4
Adverse events were not coded using MedDRA or any other standard coding dictionary. Rash was considered an efficacy parameter only and was not considered an adverse event for this 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 | Prevention (Erlotinib + Metronidazole Actavis) | Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated the same day as the start of erlotinib. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the prevention of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream). | 3 | 18 | 6 | 18 | ||
| EG001 | Treatment (Erlotinib + Metronidazole Actavis) | Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the treatment of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream). | 5 | 16 | 1 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Falling | General disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Aphthae | Gastrointestinal disorders | Non-systematic Assessment |
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| Pain | Gastrointestinal disorders | Non-systematic Assessment |
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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 |
| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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| Chest Rash: Grade 0 (n=9,9,6,6) |
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| Facial Rash: Grade 1 (n=9,9,6,6) |
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| Chest Rash: Grade 1 (n=9,9,6,6) |
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| Facial Rash: Grade 2 (n=9,9,6,6) |
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| Chest Rash: Grade 2 (n=9,9,6,6) |
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| Facial Rash: Grade 3 (n=9,9,6,6) |
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| Chest Rash: Grade 3 (n=9,9,6,6) |
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| Facial Rash: Grade 4 (n=9,9,6,6) |
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| Chest Rash: Grade 4 (n=9,9,6,6) |
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| Facial Rash: Grade 5 (n=9,9,6,6) |
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| Chest Rash: Grade 5 (n=9,9,6,6) |
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| OG002 |
| Left Side - Treatment (Erlotinib + Standard Procedures) |
Participants received erlotinib 150 mg orally daily for 4 weeks. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream) to evaluate whether it was effective in the treatment of erlotinib associated rash. |
| OG003 | Right Side - Treatment (Erlotinib + Metronidazole Actavis) | Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the treatment of erlotinib associated rash. |
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