Trial Outcomes & Findings for GTX Regimen for Biliary Cancers (NCT NCT00868998)
NCT ID: NCT00868998
Last Updated: 2016-05-23
Results Overview
Data was not analyzed due to poor accrual.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
10 weeks
Results posted on
2016-05-23
Participant Flow
Participant milestones
| Measure |
Treatment
Gemcitabine, Docetaxel, and Capecitabine
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Treatment
Gemcitabine, Docetaxel, and Capecitabine
|
|---|---|
|
Overall Study
Screen Failure
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Progression of disease
|
2
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
GTX Regimen for Biliary Cancers
Baseline characteristics by cohort
| Measure |
Treatment
n=5 Participants
Gemcitabine, Docetaxel, and Capecitabine
|
|---|---|
|
Age, Customized
50-59
|
1 participants
n=5 Participants
|
|
Age, Customized
60-69
|
3 participants
n=5 Participants
|
|
Age, Customized
70-79
|
1 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 weeksData was not analyzed due to poor accrual.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Prior to day 4 and on day 12Data was not analyzed due to poor accrual.
Outcome measures
Outcome data not reported
Adverse Events
Treatment
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment
n=4 participants at risk
Gemcitabine, Docetaxel, and Capecitabine
|
|---|---|
|
General disorders
Dehydration and low blood pressure
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Death
|
25.0%
1/4 • Number of events 1
|
Other adverse events
| Measure |
Treatment
n=4 participants at risk
Gemcitabine, Docetaxel, and Capecitabine
|
|---|---|
|
General disorders
Bruising
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Nausea
|
50.0%
2/4 • Number of events 2
|
|
General disorders
Vomiting
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
2/4 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Stomatitis
|
50.0%
2/4 • Number of events 2
|
|
General disorders
Edema
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Asthenia
|
25.0%
1/4 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
2/4 • Number of events 2
|
|
General disorders
Fatigue
|
25.0%
1/4 • Number of events 1
|
|
Nervous system disorders
Neuropathy
|
25.0%
1/4 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
25.0%
1/4 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hand Foot Syndrome
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Night sweats
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Change in taste
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Change in appetite
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Ascites
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Oral ulcer bleeding
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Mucositis
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Pain
|
25.0%
1/4 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place