Trial Outcomes & Findings for BrUOG-PA-209: Lapatinib and Gemcitabine for Metastatic Pancreaticobiliary Cancer (NCT NCT00447122)
NCT ID: NCT00447122
Last Updated: 2022-03-08
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
25 participants
Primary outcome timeframe
Date of study entry until the date of death, up to 12 months.
Results posted on
2022-03-08
Participant Flow
25 patients were enrolled
Participant milestones
| Measure |
Arm 1
lapatinib, 1,000 mg/day, and Gemcitabine, 1000mg/m2
|
Arm 2
Gem 1000mg/m2, lapatinib 1500mg/d
|
Arm 3
Gem 1000mg/m2 100 minutes oxaliplatin 100mg/m2 lapatinib 1000mg/d
|
Arm 4
Gem 1000mg/m2 100 minutes oxaliplatin 100mg/m2 lapatinib 1500mg/d
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
11
|
6
|
5
|
|
Overall Study
COMPLETED
|
3
|
10
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Arm 1
lapatinib, 1,000 mg/day, and Gemcitabine, 1000mg/m2
|
Arm 2
Gem 1000mg/m2, lapatinib 1500mg/d
|
Arm 3
Gem 1000mg/m2 100 minutes oxaliplatin 100mg/m2 lapatinib 1000mg/d
|
Arm 4
Gem 1000mg/m2 100 minutes oxaliplatin 100mg/m2 lapatinib 1500mg/d
|
|---|---|---|---|---|
|
Overall Study
worsening medical condition -came off
|
0
|
1
|
0
|
0
|
Baseline Characteristics
BrUOG-PA-209: Lapatinib and Gemcitabine for Metastatic Pancreaticobiliary Cancer
Baseline characteristics by cohort
| Measure |
Arm 1
n=3 Participants
Gemcitabine, 1000mg/m2 and lapatinib 1000mg/d
|
Arm 2
n=11 Participants
Gemcitabine, 1000mg/m2 and lapatinib 1500mg/d
|
Arm 3
n=6 Participants
Gemcitabine, 1000mg/m2 over 100minutes lapatinib 1000mg/d oxaliplatin 100mg/m2
|
Arm 4
n=5 Participants
Gemcitabine, 1000mg/m2 over 100minutes lapatinib 1500mg/d oxaliplatin 100mg/m2
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
11 participants
n=7 Participants
|
6 participants
n=5 Participants
|
5 participants
n=4 Participants
|
25 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Date of study entry until the date of death, up to 12 months.Outcome measures
| Measure |
Arm 1
n=3 Participants
Gem 1000mg/m2 lapatinib 1000mg/d
|
Arm 2
n=11 Participants
Gem 1000mg/m2 lapatinib 1500mg/d
|
Arm 3
n=6 Participants
Gem 1000mg/m2 lapatinib 1000mg/d oxaliplatin 100mg/m2
|
Arm 4
n=5 Participants
Gem 1000mg/m2 lapatinib 1500mg/d oxaliplatin 100mg/m2
|
|---|---|---|---|---|
|
Overall Survival for Patients With Metastatic Pancreatic Cancer.
|
3 participants
|
10 participants
|
6 participants
|
5 participants
|
Adverse Events
Arm 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm 3
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm 4
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=3 participants at risk
Gem 1000mg/m2 lapatinib 1000mg/d
|
Arm 2
n=11 participants at risk
Gem 1000mg/m2 lapatinib 1500mg/d
|
Arm 3
n=6 participants at risk
Gem 1000mg/m2 lapatinib 1000mg/d oxaliplatin 100mg/m2
|
Arm 4
n=5 participants at risk
Gem 1000mg/m2 lapatinib 1500mg/d oxaliplatin 100mg/m2
|
|---|---|---|---|---|
|
Investigations
pneumocystis sepsis and ARDS
|
0.00%
0/3 • Through study completion, an average of 1 year
|
9.1%
1/11 • Number of events 1 • Through study completion, an average of 1 year
|
16.7%
1/6 • Number of events 1 • Through study completion, an average of 1 year
|
40.0%
2/5 • Number of events 2 • Through study completion, an average of 1 year
|
Other adverse events
| Measure |
Arm 1
n=3 participants at risk
Gem 1000mg/m2 lapatinib 1000mg/d
|
Arm 2
n=11 participants at risk
Gem 1000mg/m2 lapatinib 1500mg/d
|
Arm 3
n=6 participants at risk
Gem 1000mg/m2 lapatinib 1000mg/d oxaliplatin 100mg/m2
|
Arm 4
n=5 participants at risk
Gem 1000mg/m2 lapatinib 1500mg/d oxaliplatin 100mg/m2
|
|---|---|---|---|---|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/3 • Through study completion, an average of 1 year
|
9.1%
1/11 • Number of events 11 • Through study completion, an average of 1 year
|
0.00%
0/6 • Through study completion, an average of 1 year
|
0.00%
0/5 • Through study completion, an average of 1 year
|
|
General disorders
fatigue
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/11 • Through study completion, an average of 1 year
|
16.7%
1/6 • Number of events 6 • Through study completion, an average of 1 year
|
0.00%
0/5 • Through study completion, an average of 1 year
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/11 • Through study completion, an average of 1 year
|
0.00%
0/6 • Through study completion, an average of 1 year
|
20.0%
1/5 • Number of events 5 • Through study completion, an average of 1 year
|
|
Metabolism and nutrition disorders
anorexia
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/11 • Through study completion, an average of 1 year
|
0.00%
0/6 • Through study completion, an average of 1 year
|
20.0%
1/5 • Number of events 5 • Through study completion, an average of 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place