Trial Outcomes & Findings for ET 743 (Yondelis) in Men With Advanced Prostate Cancer (NCT NCT00147212)
NCT ID: NCT00147212
Last Updated: 2013-01-18
Results Overview
Prostate specific antigen (PSA) response rate, as defined by the PSA Working Group Criteria (see Bubley et al, J Clin Oncol. 1999 Nov;17(11):3461-7)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Participants were followed until disease progression, an average of 6 months
Results posted on
2013-01-18
Participant Flow
Completed
Participant milestones
| Measure |
Trabectedin
Experimental arm treated with trabectedin (ET-743)
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ET 743 (Yondelis) in Men With Advanced Prostate Cancer
Baseline characteristics by cohort
| Measure |
Trabectedin
n=50 Participants
Experimental arm treated with trabectedin (ET-743)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=5 Participants
|
|
Age Continuous
|
65 years
STANDARD_DEVIATION 5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
4 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants were followed until disease progression, an average of 6 monthsPopulation: Intent to treat
Prostate specific antigen (PSA) response rate, as defined by the PSA Working Group Criteria (see Bubley et al, J Clin Oncol. 1999 Nov;17(11):3461-7)
Outcome measures
| Measure |
Trabectedin
n=50 Participants
Men with metastatic castration resistant prostate cancer (CRPC) treated with trabectedin
|
|---|---|
|
The Number of Men With Advanced Prostate Cancer Treated With Trabectedin Who Have a PSA Response
|
7 participants
Interval 0.0 to 50.0
|
Adverse Events
Trabectedin
Serious events: 10 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Trabectedin
n=50 participants at risk
Experimental arm treated with trabectedin (ET-743)
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
20.0%
10/50 • Number of events 10
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place