Trial Outcomes & Findings for Histological Characterization and Differentiation of Rash From Other Epidermal Growth Factor Receptor (EGFR) Inhibitors (NCT NCT00709878)
NCT ID: NCT00709878
Last Updated: 2015-03-17
Results Overview
Recruitment status
COMPLETED
Target enrollment
32 participants
Primary outcome timeframe
6 months
Results posted on
2015-03-17
Participant Flow
A total of 8 samples per patient/inhibitor were collected, with a total of 32 patient specimens analyzed for this study.
Participant milestones
| Measure |
Patients Treated With Lapatinib (L)
Patients treated with lapatinib who developed skin toxicities and have been biopsied for skin rash.
|
Patients Treated With Cetuximab (C)
Patients treated with cetuximab who developed skin toxicities and have been biopsied for skin rash.
|
Patients Treated With Panitumumab (P)
Patients treated with panitumumab who developed skin toxicities and have been biopsied for skin rash.
|
Patients Treated With Erlotinib (E)
Patients treated with erlotinib who developed skin toxicities and have been biopsied for a skin rash.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Histological Characterization and Differentiation of Rash From Other Epidermal Growth Factor Receptor (EGFR) Inhibitors
Baseline characteristics by cohort
| Measure |
Patients Treated With Lapatinib (L)
n=8 Participants
Patients treated with lapatinib who developed skin toxicities and have been biopsied for skin rash.
|
Patients Treated With Cetuximab (C)
n=8 Participants
Patients treated with cetuximab who developed skin toxicities and have been biopsied for skin rash.
|
Patients Treated With Panitumumab (P)
n=8 Participants
Patients treated with panitumumab who developed skin toxicities and have been biopsied for skin rash.
|
Patients Treated With Erlotinib (E)
n=8 Participants
Patients treated with erlotinib who developed skin toxicities and have been biopsied for a skin rash.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
55.7 years
n=5 Participants
|
54.5 years
n=7 Participants
|
65 years
n=5 Participants
|
66.7 years
n=4 Participants
|
60.35 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
32 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Patients Treated With Lapatinib (L)
n=8 Participants
Patients treated with lapatinib who developed skin toxicities and have been biopsied for skin rash.
|
Patients Treated With Cetuximab (C)
n=8 Participants
Patients treated with cetuximab who developed skin toxicities and have been biopsied for skin rash.
|
Patients Treated With Panitumumab (P)
n=8 Participants
Patients treated with panitumumab who developed skin toxicities and have been biopsied for skin rash.
|
Patients Treated With Erlotinib (E)
n=8 Participants
Patients treated with erlotinib who developed skin toxicities and have been biopsied for a skin rash.
|
|---|---|---|---|---|
|
Differences in Histologic Alterations in Rash Caused by Lapatinib, a Dual HER1/2 Inhibitor (HER1/2i), and the Single HER1 Inhibitors (HER1i) Cetuximab, Erlotinib,and Panitumumab.
Follicular monocytic infiltrate
|
2 Total number of cases
|
2 Total number of cases
|
2 Total number of cases
|
2 Total number of cases
|
|
Differences in Histologic Alterations in Rash Caused by Lapatinib, a Dual HER1/2 Inhibitor (HER1/2i), and the Single HER1 Inhibitors (HER1i) Cetuximab, Erlotinib,and Panitumumab.
Ulceration
|
1 Total number of cases
|
1 Total number of cases
|
0 Total number of cases
|
2 Total number of cases
|
|
Differences in Histologic Alterations in Rash Caused by Lapatinib, a Dual HER1/2 Inhibitor (HER1/2i), and the Single HER1 Inhibitors (HER1i) Cetuximab, Erlotinib,and Panitumumab.
Parakeratosis
|
1 Total number of cases
|
2 Total number of cases
|
1 Total number of cases
|
0 Total number of cases
|
|
Differences in Histologic Alterations in Rash Caused by Lapatinib, a Dual HER1/2 Inhibitor (HER1/2i), and the Single HER1 Inhibitors (HER1i) Cetuximab, Erlotinib,and Panitumumab.
Acanthosis
|
1 Total number of cases
|
1 Total number of cases
|
0 Total number of cases
|
0 Total number of cases
|
|
Differences in Histologic Alterations in Rash Caused by Lapatinib, a Dual HER1/2 Inhibitor (HER1/2i), and the Single HER1 Inhibitors (HER1i) Cetuximab, Erlotinib,and Panitumumab.
Epidermal atrophy
|
7 Total number of cases
|
5 Total number of cases
|
2 Total number of cases
|
4 Total number of cases
|
|
Differences in Histologic Alterations in Rash Caused by Lapatinib, a Dual HER1/2 Inhibitor (HER1/2i), and the Single HER1 Inhibitors (HER1i) Cetuximab, Erlotinib,and Panitumumab.
Epidermal dysmaturation
|
2 Total number of cases
|
3 Total number of cases
|
1 Total number of cases
|
0 Total number of cases
|
|
Differences in Histologic Alterations in Rash Caused by Lapatinib, a Dual HER1/2 Inhibitor (HER1/2i), and the Single HER1 Inhibitors (HER1i) Cetuximab, Erlotinib,and Panitumumab.
Epidermal dyskeratosis
|
3 Total number of cases
|
3 Total number of cases
|
0 Total number of cases
|
0 Total number of cases
|
|
Differences in Histologic Alterations in Rash Caused by Lapatinib, a Dual HER1/2 Inhibitor (HER1/2i), and the Single HER1 Inhibitors (HER1i) Cetuximab, Erlotinib,and Panitumumab.
Epidermal neutrophilc infiltrate
|
1 Total number of cases
|
1 Total number of cases
|
0 Total number of cases
|
1 Total number of cases
|
|
Differences in Histologic Alterations in Rash Caused by Lapatinib, a Dual HER1/2 Inhibitor (HER1/2i), and the Single HER1 Inhibitors (HER1i) Cetuximab, Erlotinib,and Panitumumab.
Epidermal monocytic infiltrate
|
0 Total number of cases
|
0 Total number of cases
|
2 Total number of cases
|
0 Total number of cases
|
|
Differences in Histologic Alterations in Rash Caused by Lapatinib, a Dual HER1/2 Inhibitor (HER1/2i), and the Single HER1 Inhibitors (HER1i) Cetuximab, Erlotinib,and Panitumumab.
Epidermal eosinophilic infiltrate
|
0 Total number of cases
|
0 Total number of cases
|
0 Total number of cases
|
1 Total number of cases
|
|
Differences in Histologic Alterations in Rash Caused by Lapatinib, a Dual HER1/2 Inhibitor (HER1/2i), and the Single HER1 Inhibitors (HER1i) Cetuximab, Erlotinib,and Panitumumab.
Dermal neutrophilic infiltrate
|
2 Total number of cases
|
0 Total number of cases
|
2 Total number of cases
|
4 Total number of cases
|
|
Differences in Histologic Alterations in Rash Caused by Lapatinib, a Dual HER1/2 Inhibitor (HER1/2i), and the Single HER1 Inhibitors (HER1i) Cetuximab, Erlotinib,and Panitumumab.
Dermal monocytic infiltrate
|
1 Total number of cases
|
4 Total number of cases
|
4 Total number of cases
|
4 Total number of cases
|
|
Differences in Histologic Alterations in Rash Caused by Lapatinib, a Dual HER1/2 Inhibitor (HER1/2i), and the Single HER1 Inhibitors (HER1i) Cetuximab, Erlotinib,and Panitumumab.
Dermal eosinophilic infiltrate
|
2 Total number of cases
|
2 Total number of cases
|
0 Total number of cases
|
0 Total number of cases
|
|
Differences in Histologic Alterations in Rash Caused by Lapatinib, a Dual HER1/2 Inhibitor (HER1/2i), and the Single HER1 Inhibitors (HER1i) Cetuximab, Erlotinib,and Panitumumab.
Follicular concretions
|
3 Total number of cases
|
5 Total number of cases
|
2 Total number of cases
|
3 Total number of cases
|
|
Differences in Histologic Alterations in Rash Caused by Lapatinib, a Dual HER1/2 Inhibitor (HER1/2i), and the Single HER1 Inhibitors (HER1i) Cetuximab, Erlotinib,and Panitumumab.
Follicular neutrophilic pustule
|
3 Total number of cases
|
4 Total number of cases
|
3 Total number of cases
|
6 Total number of cases
|
|
Differences in Histologic Alterations in Rash Caused by Lapatinib, a Dual HER1/2 Inhibitor (HER1/2i), and the Single HER1 Inhibitors (HER1i) Cetuximab, Erlotinib,and Panitumumab.
Dysmorphic follicle
|
4 Total number of cases
|
2 Total number of cases
|
2 Total number of cases
|
4 Total number of cases
|
|
Differences in Histologic Alterations in Rash Caused by Lapatinib, a Dual HER1/2 Inhibitor (HER1/2i), and the Single HER1 Inhibitors (HER1i) Cetuximab, Erlotinib,and Panitumumab.
Follicular dyskeratosis
|
4 Total number of cases
|
3 Total number of cases
|
1 Total number of cases
|
1 Total number of cases
|
|
Differences in Histologic Alterations in Rash Caused by Lapatinib, a Dual HER1/2 Inhibitor (HER1/2i), and the Single HER1 Inhibitors (HER1i) Cetuximab, Erlotinib,and Panitumumab.
Follicular neurtrophilic infiltrate
|
5 Total number of cases
|
5 Total number of cases
|
3 Total number of cases
|
7 Total number of cases
|
|
Differences in Histologic Alterations in Rash Caused by Lapatinib, a Dual HER1/2 Inhibitor (HER1/2i), and the Single HER1 Inhibitors (HER1i) Cetuximab, Erlotinib,and Panitumumab.
Follicular eosinophilic infiltrate
|
2 Total number of cases
|
1 Total number of cases
|
1 Total number of cases
|
1 Total number of cases
|
|
Differences in Histologic Alterations in Rash Caused by Lapatinib, a Dual HER1/2 Inhibitor (HER1/2i), and the Single HER1 Inhibitors (HER1i) Cetuximab, Erlotinib,and Panitumumab.
Eccrine dyskeratosis
|
0 Total number of cases
|
1 Total number of cases
|
0 Total number of cases
|
0 Total number of cases
|
|
Differences in Histologic Alterations in Rash Caused by Lapatinib, a Dual HER1/2 Inhibitor (HER1/2i), and the Single HER1 Inhibitors (HER1i) Cetuximab, Erlotinib,and Panitumumab.
Eccrine necrosis
|
0 Total number of cases
|
2 Total number of cases
|
0 Total number of cases
|
1 Total number of cases
|
|
Differences in Histologic Alterations in Rash Caused by Lapatinib, a Dual HER1/2 Inhibitor (HER1/2i), and the Single HER1 Inhibitors (HER1i) Cetuximab, Erlotinib,and Panitumumab.
Eccrine infiltrate
|
0 Total number of cases
|
0 Total number of cases
|
0 Total number of cases
|
0 Total number of cases
|
|
Differences in Histologic Alterations in Rash Caused by Lapatinib, a Dual HER1/2 Inhibitor (HER1/2i), and the Single HER1 Inhibitors (HER1i) Cetuximab, Erlotinib,and Panitumumab.
Sebaceous infiltrate
|
0 Total number of cases
|
1 Total number of cases
|
1 Total number of cases
|
3 Total number of cases
|
Adverse Events
Patients Treated With Lapatinib (L)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patients Treated With Cetuximab (C)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patients Treated With Panitumumab (P)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patients Treated With Erlotinib (E)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place