Trial Outcomes & Findings for A Study of Metronidazole Cream in the Prevention and Treatment of Tarceva (Erlotinib)-Associated Rash (NCT NCT00642473)
NCT ID: NCT00642473
Last Updated: 2016-05-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
After 2 weeks of metronidazole treatment
Results posted on
2016-05-23
Participant Flow
Participant milestones
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
16
|
|
Overall Study
COMPLETED
|
14
|
5
|
|
Overall Study
NOT COMPLETED
|
4
|
11
|
Reasons for withdrawal
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
5
|
|
Overall Study
Progression or death
|
2
|
4
|
|
Overall Study
Other
|
2
|
2
|
Baseline Characteristics
A Study of Metronidazole Cream in the Prevention and Treatment of Tarceva (Erlotinib)-Associated Rash
Baseline characteristics by cohort
| Measure |
Prevention (Erlotinib + Metronidazole Actavis)
n=18 Participants
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).
|
Treatment (Erlotinib + Metronidazole Actavis)
n=16 Participants
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).
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
70 years
STANDARD_DEVIATION 13.1 • n=7 Participants
|
69 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After 2 weeks of metronidazole treatmentPopulation: All enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome in respective arms.
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.
Outcome measures
| Measure |
Left Side - Prevention (Erlotinib + Standard Procedures)
n=9 Participants
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 prevention of erlotinib associated rash .
|
Right Side - Prevention (Erlotinib + Metronidazole Actavis)
n=9 Participants
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 prevention of erlotinib associated rash.
|
Left Side - Treatment (Erlotinib + Standard Procedures)
n=6 Participants
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.
|
Right Side - Treatment (Erlotinib + Metronidazole Actavis)
n=6 Participants
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.
|
|---|---|---|---|---|
|
Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2
Facial Rash: Grade 0 (n=9,9,6,6)
|
11 percentage of participants
|
22 percentage of participants
|
0 percentage of participants
|
33 percentage of participants
|
|
Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2
Chest Rash: Grade 0 (n=9,9,6,6)
|
56 percentage of participants
|
56 percentage of participants
|
33 percentage of participants
|
50 percentage of participants
|
|
Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2
Facial Rash: Grade 1 (n=9,9,6,6)
|
33 percentage of participants
|
22 percentage of participants
|
50 percentage of participants
|
33 percentage of participants
|
|
Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2
Chest Rash: Grade 1 (n=9,9,6,6)
|
33 percentage of participants
|
33 percentage of participants
|
17 percentage of participants
|
17 percentage of participants
|
|
Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2
Facial Rash: Grade 2 (n=9,9,6,6)
|
22 percentage of participants
|
33 percentage of participants
|
33 percentage of participants
|
17 percentage of participants
|
|
Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2
Chest Rash: Grade 2 (n=9,9,6,6)
|
11 percentage of participants
|
11 percentage of participants
|
33 percentage of participants
|
17 percentage of participants
|
|
Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2
Facial Rash: Grade 3 (n=9,9,6,6)
|
33 percentage of participants
|
22 percentage of participants
|
17 percentage of participants
|
17 percentage of participants
|
|
Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2
Chest Rash: Grade 3 (n=9,9,6,6)
|
0 percentage of participants
|
0 percentage of participants
|
17 percentage of participants
|
17 percentage of participants
|
|
Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2
Facial Rash: Grade 4 (n=9,9,6,6)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2
Chest Rash: Grade 4 (n=9,9,6,6)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2
Facial Rash: Grade 5 (n=9,9,6,6)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2
Chest Rash: Grade 5 (n=9,9,6,6)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: After 4 weeks of metronidazole treatmentPopulation: All enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome in respective arms.
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.
Outcome measures
| Measure |
Left Side - Prevention (Erlotinib + Standard Procedures)
n=8 Participants
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 prevention of erlotinib associated rash .
|
Right Side - Prevention (Erlotinib + Metronidazole Actavis)
n=8 Participants
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 prevention of erlotinib associated rash.
|
Left Side - Treatment (Erlotinib + Standard Procedures)
n=4 Participants
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.
|
Right Side - Treatment (Erlotinib + Metronidazole Actavis)
n=4 Participants
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.
|
|---|---|---|---|---|
|
Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4
Facial Rash: Grade 0 (n=8,8,4,4)
|
13 percentage of participants
|
25 percentage of participants
|
0 percentage of participants
|
25 percentage of participants
|
|
Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4
Chest Rash: Grade 0 (n=8,8,4,4)
|
75 percentage of participants
|
63 percentage of participants
|
25 percentage of participants
|
50 percentage of participants
|
|
Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4
Facial Rash: Grade 1 (n=8,8,4,4)
|
63 percentage of participants
|
50 percentage of participants
|
50 percentage of participants
|
50 percentage of participants
|
|
Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4
Chest Rash: Grade 1 (n=8,8,4,4)
|
0 percentage of participants
|
13 percentage of participants
|
25 percentage of participants
|
25 percentage of participants
|
|
Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4
Facial Rash: Grade 2 (n=8,8,4,4)
|
13 percentage of participants
|
25 percentage of participants
|
25 percentage of participants
|
50 percentage of participants
|
|
Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4
Chest Rash: Grade 2 (n=8,8,4,4)
|
13 percentage of participants
|
13 percentage of participants
|
25 percentage of participants
|
25 percentage of participants
|
|
Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4
Facial Rash: Grade 3 (n=8,8,4,4)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4
Chest Rash: Grade 3 (n=8,8,4,4)
|
0 percentage of participants
|
13 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4
Facial Rash: Grade 4 (n=8,8,4,4)
|
13 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4
Chest Rash: Grade 4 (n=8,8,4,4)
|
13 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4
Facial Rash: Grade 5 (n=8,8,4,4)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4
Chest Rash: Grade 5 (n=8,8,4,4)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Prevention (Erlotinib + Metronidazole Actavis)
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Treatment (Erlotinib + Metronidazole Actavis)
Serious events: 5 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prevention (Erlotinib + Metronidazole Actavis)
n=18 participants at risk
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).
|
Treatment (Erlotinib + Metronidazole Actavis)
n=16 participants at risk
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).
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
5.6%
1/18 • 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.
|
0.00%
0/16 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/18 • 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.
|
6.2%
1/16 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death
|
11.1%
2/18 • 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.
|
18.8%
3/16 • 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.
|
|
General disorders
Falling
|
0.00%
0/18 • 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.
|
6.2%
1/16 • 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.
|
Other adverse events
| Measure |
Prevention (Erlotinib + Metronidazole Actavis)
n=18 participants at risk
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).
|
Treatment (Erlotinib + Metronidazole Actavis)
n=16 participants at risk
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).
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
22.2%
4/18 • 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.
|
6.2%
1/16 • 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.
|
|
Gastrointestinal disorders
Aphthae
|
5.6%
1/18 • 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.
|
0.00%
0/16 • 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.
|
|
Gastrointestinal disorders
Pain
|
5.6%
1/18 • 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.
|
0.00%
0/16 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER