Trial Outcomes & Findings for A Phase I/II Clinical Trial of Vorinostat in Combination With Erlotinib for Patients With Relapsed/Refractory Non-Small-Cell Lung Cancer (0683-025) (NCT NCT00251589)
NCT ID: NCT00251589
Last Updated: 2015-03-06
Results Overview
Adverse event(s) that determined the treatment dose level was not tolerable for that patient in Cycle 1 of the Phase I portion of the study.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
23 participants
Primary outcome timeframe
Day 1 to 28 in the Phase I portion of the study
Results posted on
2015-03-06
Participant Flow
This study was conducted at 12 investigative sites in the United States. The first patient's first visit was 30 March 2006. The study was terminated early on 12 Oct 2007 and the last patient's last visit was 30 Oct 2007.
Enrolled patients were assigned to 1 of 2 dose escalating cohorts (A and B) in the Phase I portion of the study to determine the maximum tolerated dose (MTD). Once determined, new patients were assigned to the Phase II portion of the study and treated with the MTD. Active Phase I patients continued into Phase II.
Participant milestones
| Measure |
Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
|
Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk
Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
3
|
2
|
2
|
|
Overall Study
COMPLETED
|
1
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
15
|
3
|
2
|
2
|
Reasons for withdrawal
| Measure |
Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
|
Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk
Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
1
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
|
Overall Study
Discontinued due to progressive disease
|
9
|
1
|
0
|
1
|
Baseline Characteristics
A Phase I/II Clinical Trial of Vorinostat in Combination With Erlotinib for Patients With Relapsed/Refractory Non-Small-Cell Lung Cancer (0683-025)
Baseline characteristics by cohort
| Measure |
Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
n=16 Participants
Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
|
Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
n=3 Participants
Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
n=2 Participants
Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk
n=2 Participants
Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
53.0 Years
STANDARD_DEVIATION 4.36 • n=5 Participants
|
66.0 Years
STANDARD_DEVIATION 8.49 • n=7 Participants
|
48.5 Years
STANDARD_DEVIATION 20.51 • n=5 Participants
|
59.1 Years
STANDARD_DEVIATION 11.59 • n=4 Participants
|
60.7 Years
STANDARD_DEVIATION 11.41 • n=21 Participants
|
|
Age, Customized
≤ 65 years
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Age, Customized
> 65 years
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1 to 28 in the Phase I portion of the studyPopulation: All patients as treated population in Cycle 1 of the Phase I portion of the study.
Adverse event(s) that determined the treatment dose level was not tolerable for that patient in Cycle 1 of the Phase I portion of the study.
Outcome measures
| Measure |
Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
n=4 Participants
Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
|
Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
n=3 Participants
Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
n=2 Participants
Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk
n=2 Participants
Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
|---|---|---|---|---|
|
Dose Limiting Toxicity (DLT) Occurring in Cycle 1 of the Phase I Portion of the Study
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 1 to 28 in the Phase II portion of the studyPopulation: All patients as treated population in Cycle 1 of the Phase II portion of the study.
Adverse event(s) that determined the treatment dose level was not tolerable for that patient in Cycle 1 of the Phase II portion of the study.
Outcome measures
| Measure |
Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
n=12 Participants
Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
|
Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk
Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
|---|---|---|---|---|
|
Dose Limiting Toxicity Occurring in Cycle 1 of the Phase II Portion of the Study
|
3 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every 57 days beginning with Cycle 3, or more frequently if appropriatePopulation: All patients as treated population with post-baseline data available to determine Unconfirmed Partial Response as Best Response.
An unconfirmed partial response is defined as a partial response that has not been confirmed by a follow up CT scan (or MRI) at least 4 weeks after the criteria for response are first met. (A partial response is defined as an at least 30% reduction in the sum of the longest diameter of the target lesions. Non-target lesions must be at least stable)
Outcome measures
| Measure |
Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
n=13 Participants
Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
|
Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
n=1 Participants
Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
n=1 Participants
Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk
n=1 Participants
Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
|---|---|---|---|---|
|
Unconfirmed Partial Response (UPR) Based on Response Criteria in Solid Tumors (RECIST)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Every 57 days beginning with Cycle 3, or more frequently if appropriatePopulation: All patients treated population with post-baseline data available to determine Stable Disease as Best Response.
Stable disease is defined as less than a radiographic partial response, but not progressive disease
Outcome measures
| Measure |
Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
n=13 Participants
Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
|
Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
n=1 Participants
Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
n=1 Participants
Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk
n=1 Participants
Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
|---|---|---|---|---|
|
Stable Disease (SD) as Best Response Based on Response Criteria in Solid Tumors (RECIST)
|
6 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Every 57 days beginning with Cycle 3, or more frequently if appropriatePopulation: All patients as treated population with post-baseline data available to determine Progressive Disease as Best Response.
Progressive disease is defined as a ≥20% increase in the sum of the longest diameter, the appearance of one or more new lesions and/or unequivocal progression of non-target lesions by conventional or spiral CT or MRI
Outcome measures
| Measure |
Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
n=13 Participants
Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
|
Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
n=1 Participants
Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
n=1 Participants
Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk
n=1 Participants
Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
|---|---|---|---|---|
|
Progressive Disease (PD) as Best Response Based on Response Criteria in Solid Tumors (RECIST)
|
7 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Every 57 days beginning with Cycle 3 (Week 8), or more frequently if appropriatePopulation: All patients as treated population with post-baseline data available to determine Disease Progression After Week 8.
First documentation of Progressive Disease (PD) occurring \> 8 weeks on study.
Outcome measures
| Measure |
Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
n=13 Participants
Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
|
Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
n=1 Participants
Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
n=1 Participants
Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk
n=1 Participants
Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
|---|---|---|---|---|
|
Disease Progression After Week 8 Based on Response Criteria in Solid Tumors (RECIST)
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 to disease progression or deathPopulation: All patients as treated population with post-baseline data available to determine progression free survival. Cohort A, Dose Level 1 (Amended), Cohort B, Dose Level 2 and Cohort A, Dose Level 1 (Original) are not represented in the below table as post-baseline data were not available to determine progression free survival.
Progression-free survival was measured from the start of the treatment to the time when the criteria for progression was met or death due to any cause (whichever is first recorded).
Outcome measures
| Measure |
Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
n=13 Participants
Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
|
Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk
Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
|---|---|---|---|---|
|
Progression-free Survival
|
57 Days
Interval 26.0 to 113.0
|
—
|
—
|
—
|
POST_HOC outcome
Timeframe: After day 28 in the Phase II portion of the studyPopulation: All patients as treated population in Cycles 2 and beyond of the Phase II portion of the study.
Adverse event(s) that determined the treatment dose level was not tolerable for that patient in Cycles 2 and beyond of the Phase II portion of the study.
Outcome measures
| Measure |
Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
n=12 Participants
Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
|
Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk
Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
|---|---|---|---|---|
|
Dose Limiting Toxicity Occurring in Cycles 2 and Beyond of the Phase II Portion of the Study
|
3 Participants
|
—
|
—
|
—
|
Adverse Events
Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
Serious events: 6 serious events
Other events: 16 other events
Deaths: 0 deaths
Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
n=16 participants at risk
Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
|
Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
n=3 participants at risk
Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
n=2 participants at risk
Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk
n=2 participants at risk
Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • Number of events 2
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Number of events 2
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
Infection
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
Pneumococcal bacteraemia
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
12.5%
2/16 • Number of events 2
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/16
|
0.00%
0/3
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/16
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
0.00%
0/2
|
|
Renal and urinary disorders
Urinary retention
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.00%
0/16
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
0.00%
0/2
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/16
|
0.00%
0/3
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
Other adverse events
| Measure |
Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
n=16 participants at risk
Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
|
Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
n=3 participants at risk
Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
n=2 participants at risk
Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk
n=2 participants at risk
Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.2%
1/16 • Number of events 3
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/16
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
0.00%
0/2
|
|
Cardiac disorders
Bradycardia
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Cardiac disorders
Palpitations
|
0.00%
0/16
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
0.00%
0/2
|
|
Eye disorders
Dry eye
|
12.5%
2/16 • Number of events 2
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Eye disorders
Eye irritation
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Eye disorders
Eye pain
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Eye disorders
Eye pruritus
|
6.2%
1/16 • Number of events 2
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Eye disorders
Eyelids pruritus
|
6.2%
1/16 • Number of events 4
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Eye disorders
Keratoconjunctivitis sicca
|
12.5%
2/16 • Number of events 2
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Eye disorders
Lacrimation increased
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Eye disorders
Photopsia
|
0.00%
0/16
|
0.00%
0/3
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
2/16 • Number of events 4
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.2%
1/16 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
Breath odour
|
0.00%
0/16
|
0.00%
0/3
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
|
Gastrointestinal disorders
Cheilitis
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
100.0%
2/2 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
81.2%
13/16 • Number of events 32
|
100.0%
3/3 • Number of events 6
|
100.0%
2/2 • Number of events 8
|
100.0%
2/2 • Number of events 4
|
|
Gastrointestinal disorders
Dry mouth
|
12.5%
2/16 • Number of events 2
|
0.00%
0/3
|
0.00%
0/2
|
50.0%
1/2 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
2/16 • Number of events 2
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/16
|
0.00%
0/3
|
0.00%
0/2
|
50.0%
1/2 • Number of events 2
|
|
Gastrointestinal disorders
Flatulence
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
50.0%
1/2 • Number of events 2
|
0.00%
0/2
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
Gingival pain
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/16
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
Melaena
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
Nausea
|
81.2%
13/16 • Number of events 21
|
66.7%
2/3 • Number of events 2
|
100.0%
2/2 • Number of events 5
|
100.0%
2/2 • Number of events 3
|
|
Gastrointestinal disorders
Oesophagitis
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
Rectal fissure
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
Stomatitis
|
18.8%
3/16 • Number of events 4
|
0.00%
0/3
|
50.0%
1/2 • Number of events 3
|
0.00%
0/2
|
|
Gastrointestinal disorders
Vomiting
|
37.5%
6/16 • Number of events 14
|
33.3%
1/3 • Number of events 1
|
100.0%
2/2 • Number of events 3
|
100.0%
2/2 • Number of events 3
|
|
General disorders
Asthenia
|
18.8%
3/16 • Number of events 4
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
General disorders
Catheter site pain
|
0.00%
0/16
|
0.00%
0/3
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
|
General disorders
Chest pain
|
6.2%
1/16 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
0.00%
0/2
|
|
General disorders
Chills
|
18.8%
3/16 • Number of events 4
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
General disorders
Face oedema
|
0.00%
0/16
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
0.00%
0/2
|
|
General disorders
Fatigue
|
50.0%
8/16 • Number of events 14
|
33.3%
1/3 • Number of events 4
|
0.00%
0/2
|
100.0%
2/2 • Number of events 2
|
|
General disorders
Non-cardiac chest pain
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
General disorders
Oedema
|
18.8%
3/16 • Number of events 4
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
General disorders
Pain
|
0.00%
0/16
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
|
General disorders
Pyrexia
|
18.8%
3/16 • Number of events 4
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/16
|
0.00%
0/3
|
50.0%
1/2 • Number of events 5
|
0.00%
0/2
|
|
Infections and infestations
Candidiasis
|
0.00%
0/16
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
Eye infection
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
Gastroenteritis viral
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
Infection
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
Vaginal infection
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/16
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
0.00%
0/2
|
|
Investigations
Blood creatinine increased
|
0.00%
0/16
|
0.00%
0/3
|
50.0%
1/2 • Number of events 3
|
0.00%
0/2
|
|
Investigations
Blood glucose decreased
|
6.2%
1/16 • Number of events 2
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Investigations
Blood glucose increased
|
6.2%
1/16 • Number of events 2
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Investigations
Blood phosphorus decreased
|
6.2%
1/16 • Number of events 2
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Investigations
Blood sodium decreased
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Investigations
Blood urine present
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Investigations
International normalised ratio increased
|
0.00%
0/16
|
0.00%
0/3
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Investigations
Weight decreased
|
37.5%
6/16 • Number of events 7
|
33.3%
1/3 • Number of events 2
|
100.0%
2/2 • Number of events 2
|
50.0%
1/2 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
62.5%
10/16 • Number of events 15
|
33.3%
1/3 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Dehydration
|
18.8%
3/16 • Number of events 4
|
33.3%
1/3 • Number of events 1
|
50.0%
1/2 • Number of events 2
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Failure to thrive
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.2%
1/16 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/16
|
0.00%
0/3
|
50.0%
1/2 • Number of events 2
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/16
|
0.00%
0/3
|
50.0%
1/2 • Number of events 2
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/16
|
0.00%
0/3
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
2/16 • Number of events 2
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.2%
1/16 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
50.0%
1/2 • Number of events 2
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/16
|
0.00%
0/3
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Nervous system disorders
Dizziness
|
18.8%
3/16 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
50.0%
1/2 • Number of events 2
|
|
Nervous system disorders
Dysgeusia
|
25.0%
4/16 • Number of events 4
|
0.00%
0/3
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/16
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
0.00%
0/2
|
|
Nervous system disorders
Headache
|
12.5%
2/16 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
50.0%
1/2 • Number of events 2
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/16
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
0.00%
0/2
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/16
|
0.00%
0/3
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Nervous system disorders
Peripheral motor neuropathy
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
12.5%
2/16 • Number of events 2
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Nervous system disorders
Syncope
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Psychiatric disorders
Anxiety
|
6.2%
1/16 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/16
|
33.3%
1/3 • Number of events 2
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Psychiatric disorders
Depression
|
0.00%
0/16
|
0.00%
0/3
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/16
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
0.00%
0/2
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/16
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
|
Psychiatric disorders
Nightmare
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/16
|
0.00%
0/3
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Reproductive system and breast disorders
Perineal pain
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
2/16 • Number of events 2
|
0.00%
0/3
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
4/16 • Number of events 4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
50.0%
1/2 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
2/16 • Number of events 2
|
0.00%
0/3
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/16
|
0.00%
0/3
|
50.0%
1/2 • Number of events 2
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
6.2%
1/16 • Number of events 2
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
1/16 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
43.8%
7/16 • Number of events 7
|
0.00%
0/3
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
6.2%
1/16 • Number of events 2
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
6.2%
1/16 • Number of events 3
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
2/16 • Number of events 2
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Rash
|
56.2%
9/16 • Number of events 13
|
100.0%
3/3 • Number of events 4
|
0.00%
0/2
|
100.0%
2/2 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/16
|
33.3%
1/3 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Vascular disorders
Hypertension
|
6.2%
1/16 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Vascular disorders
Hypotension
|
12.5%
2/16 • Number of events 3
|
0.00%
0/3
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Vascular disorders
Phlebitis
|
0.00%
0/16
|
0.00%
0/3
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER