Trial Outcomes & Findings for Dasatinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer (NCT NCT00507767)
NCT ID: NCT00507767
Last Updated: 2014-10-01
Results Overview
Progression-free survival (PFS) is defined as stable disease or better. Participants who have received at least one dose of dasatinib and who die or leave the study before 12 weeks will be counted as having progressive disease.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
At 12-weeks
Results posted on
2014-10-01
Participant Flow
Recruitment period: July 24, 2007 to February 26, 2009. Al recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
Participant milestones
| Measure |
Dasatinib
100 mg orally twice daily
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dasatinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Dasatinib
n=15 Participants
100 mg orally twice daily
|
|---|---|
|
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
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
54 years
FULL_RANGE 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 12-weeksPopulation: Analysis per protocol.
Progression-free survival (PFS) is defined as stable disease or better. Participants who have received at least one dose of dasatinib and who die or leave the study before 12 weeks will be counted as having progressive disease.
Outcome measures
| Measure |
Dasatinib
n=15 Participants
100 mg orally twice daily
|
|---|---|
|
Number of Participants With Progression-free Survival at 12-weeks
|
1 participants
Interval 0.2 to 0.05
|
Adverse Events
Dasatinib
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dasatinib
n=15 participants at risk
100 mg orally twice daily
|
|---|---|
|
General disorders
Dehydration
|
6.7%
1/15 • Treatment period three 4-week cycles for total of 12 weeks with follow up every 2 cycles following first cycle. Study data collection period for all participants was 18 months.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
6.7%
1/15 • Treatment period three 4-week cycles for total of 12 weeks with follow up every 2 cycles following first cycle. Study data collection period for all participants was 18 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
6.7%
1/15 • Treatment period three 4-week cycles for total of 12 weeks with follow up every 2 cycles following first cycle. Study data collection period for all participants was 18 months.
|
|
General disorders
Toxicity
|
26.7%
4/15 • Treatment period three 4-week cycles for total of 12 weeks with follow up every 2 cycles following first cycle. Study data collection period for all participants was 18 months.
|
Other adverse events
| Measure |
Dasatinib
n=15 participants at risk
100 mg orally twice daily
|
|---|---|
|
General disorders
Anorexia
|
13.3%
2/15 • Treatment period three 4-week cycles for total of 12 weeks with follow up every 2 cycles following first cycle. Study data collection period for all participants was 18 months.
|
|
Gastrointestinal disorders
nausea/vomiting
|
100.0%
15/15 • Treatment period three 4-week cycles for total of 12 weeks with follow up every 2 cycles following first cycle. Study data collection period for all participants was 18 months.
|
|
Gastrointestinal disorders
diarrhea
|
6.7%
1/15 • Treatment period three 4-week cycles for total of 12 weeks with follow up every 2 cycles following first cycle. Study data collection period for all participants was 18 months.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
6.7%
1/15 • Treatment period three 4-week cycles for total of 12 weeks with follow up every 2 cycles following first cycle. Study data collection period for all participants was 18 months.
|
|
General disorders
dehydration
|
6.7%
1/15 • Treatment period three 4-week cycles for total of 12 weeks with follow up every 2 cycles following first cycle. Study data collection period for all participants was 18 months.
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
13.3%
2/15 • Treatment period three 4-week cycles for total of 12 weeks with follow up every 2 cycles following first cycle. Study data collection period for all participants was 18 months.
|
|
General disorders
edema: limb
|
20.0%
3/15 • Treatment period three 4-week cycles for total of 12 weeks with follow up every 2 cycles following first cycle. Study data collection period for all participants was 18 months.
|
|
Ear and labyrinth disorders
Hearing (without monitoring)
|
6.7%
1/15 • Treatment period three 4-week cycles for total of 12 weeks with follow up every 2 cycles following first cycle. Study data collection period for all participants was 18 months.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
6.7%
1/15 • Treatment period three 4-week cycles for total of 12 weeks with follow up every 2 cycles following first cycle. Study data collection period for all participants was 18 months.
|
|
Infections and infestations
Infection
|
6.7%
1/15 • Treatment period three 4-week cycles for total of 12 weeks with follow up every 2 cycles following first cycle. Study data collection period for all participants was 18 months.
|
|
General disorders
Pain (bone)
|
6.7%
1/15 • Treatment period three 4-week cycles for total of 12 weeks with follow up every 2 cycles following first cycle. Study data collection period for all participants was 18 months.
|
Additional Information
Dr. Vassiliki Papadimitrakopoulou, Professor
MD Anderson Cancer Center
Phone: 713-792-6363
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60