Trial Outcomes & Findings for A Trial of GW572016, Gemcitabine and Oxaliplatin for Metastatic Pancreaticobiliary Cancer Schema (NCT NCT00439179)
NCT ID: NCT00439179
Last Updated: 2020-02-17
Results Overview
To determine the safety and tolerability of GW572016 when administered with gemcitabine and the combination of gemcitabine and oxaliplatin in patients with advanced pancreaticobiliary cancers. Numbers below are DLTs
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
27 participants
Primary outcome timeframe
until death, approximately 2 years
Results posted on
2020-02-17
Participant Flow
Patients with both pancreatic and bilary cancer were enrolled
Participant milestones
| Measure |
Cohort 1
Cohort 1: Weekly gem + GW572016, 1000mg/day. (combination)
|
Cohort 2
Cohort 2: Weekly gem + GW572016, 1500 mg/day. (combination)
|
Cohort 3
Cohort 3: GEMOX + GW572016 1000 mg/day. (combination)
|
Cohort 4
Cohort 4: GEMOX + GW572016 1500 mg/day.(combination)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
13
|
6
|
5
|
|
Overall Study
COMPLETED
|
3
|
11
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1
Cohort 1: Weekly gem + GW572016, 1000mg/day. (combination)
|
Cohort 2
Cohort 2: Weekly gem + GW572016, 1500 mg/day. (combination)
|
Cohort 3
Cohort 3: GEMOX + GW572016 1000 mg/day. (combination)
|
Cohort 4
Cohort 4: GEMOX + GW572016 1500 mg/day.(combination)
|
|---|---|---|---|---|
|
Overall Study
* 1 pt inelig, 1 pt numb not used
|
0
|
2
|
0
|
0
|
Baseline Characteristics
A Trial of GW572016, Gemcitabine and Oxaliplatin for Metastatic Pancreaticobiliary Cancer Schema
Baseline characteristics by cohort
| Measure |
Cohort 1
n=3 Participants
Cohort 1: Weekly gem + GW572016, 1000mg/day.
|
Cohort 2
n=11 Participants
Cohort 2: Weekly gem + GW572016, 1500 mg/day.
|
Cohort 3
n=6 Participants
Cohort 3: GEMOX + GW572016 1000 mg/day.
|
Cohort 4
n=5 Participants
Cohort 4: GEMOX + GW572016 1500 mg/day
|
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
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Age, Continuous
|
58.6 years
STANDARD_DEVIATION 17 • n=5 Participants
|
66 years
STANDARD_DEVIATION 11 • n=7 Participants
|
61.5 years
STANDARD_DEVIATION 6 • n=5 Participants
|
64.2 years
STANDARD_DEVIATION 12 • n=4 Participants
|
63.7 years
STANDARD_DEVIATION 10.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
14 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: until death, approximately 2 yearsTo determine the safety and tolerability of GW572016 when administered with gemcitabine and the combination of gemcitabine and oxaliplatin in patients with advanced pancreaticobiliary cancers. Numbers below are DLTs
Outcome measures
| Measure |
Cohorts 1
n=3 Participants
Cohort 1: Weekly gem + GW572016, 1000mg/day.
|
Cohort 2
n=11 Participants
weekly gem+ GW572016, 1500mg/day
|
Cohort 3
n=6 Participants
GEMOX+ GW572016 1000mg day
|
Cohort 4
n=5 Participants
GEMOX+ GW572016 1500mg/day
|
|---|---|---|---|---|
|
Toxicity (Number of Patients Who Experiened DLTs)
|
0 participants
|
1 participants
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: every two months until progressionTo assess clinical activity of GW572016 with gemcitabine and with the combination of gemcitabine and oxaliplatin in patients with advanced pancreaticobiliary cancers.
Outcome measures
| Measure |
Cohorts 1
n=3 Participants
Cohort 1: Weekly gem + GW572016, 1000mg/day.
|
Cohort 2
n=11 Participants
weekly gem+ GW572016, 1500mg/day
|
Cohort 3
n=6 Participants
GEMOX+ GW572016 1000mg day
|
Cohort 4
n=5 Participants
GEMOX+ GW572016 1500mg/day
|
|---|---|---|---|---|
|
Number of Patients Who Experienced a Partial Response
|
0 participants
|
2 participants
|
1 participants
|
1 participants
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 4
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=3 participants at risk
Cohort 1: Weekly gem + GW572016, 1000mg/day.
|
Cohort 2
n=11 participants at risk
Cohort 2: Weekly gem + GW572016, 1500 mg/day.
|
Cohort 3
n=6 participants at risk
Cohort 3: GEMOX + GW572016 1000 mg/day.
|
Cohort 4
n=5 participants at risk
Cohort 4: GEMOX + GW572016 1500 mg/day
|
|---|---|---|---|---|
|
Investigations
Gr 3 Infection
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
Other adverse events
| Measure |
Cohort 1
n=3 participants at risk
Cohort 1: Weekly gem + GW572016, 1000mg/day.
|
Cohort 2
n=11 participants at risk
Cohort 2: Weekly gem + GW572016, 1500 mg/day.
|
Cohort 3
n=6 participants at risk
Cohort 3: GEMOX + GW572016 1000 mg/day.
|
Cohort 4
n=5 participants at risk
Cohort 4: GEMOX + GW572016 1500 mg/day
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
0.00%
0/6
|
0.00%
0/5
|
|
Investigations
Fatigue
|
0.00%
0/3
|
0.00%
0/11
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
|
Investigations
nausea
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
|
Investigations
anorexia
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place