Trial Outcomes & Findings for Carboplatin and Paclitaxel in Patients With Metastatic, Castrate-Resistant Prostate Cancer (NCT NCT01558492)
NCT ID: NCT01558492
Last Updated: 2017-06-09
Results Overview
TERMINATED
PHASE2
3 participants
Baseline, week 4, week 8, week 12, week 16, week 20, week 24 and end of study.
2017-06-09
Participant Flow
Participant milestones
| Measure |
All Subjects
Carboplatin and Paclitaxel
Carboplatin: AUC = 5 intravenously (IV) on day 1 of a 28 day cycle
Paclitaxel: 80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Carboplatin and Paclitaxel in Patients With Metastatic, Castrate-Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
All Subjects
n=3 Participants
Carboplatin and Paclitaxel
Carboplatin: AUC = 5 intravenously (IV) on day 1 of a 28 day cycle
Paclitaxel: 80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, week 4, week 8, week 12, week 16, week 20, week 24 and end of study.Population: This study was terminated early due to poor accrual. There were no publications as a result. Data were not collected.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, week 12, week 24 and end of study.Population: This study was terminated early due to poor accrual. There were no publications as a result. Data were not collected.
Assessed by CT or MRI scan and/or bone scan.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months and 48 months.Population: This study was terminated early due to poor accrual. There were no publications as a result. Data were not collected.
Outcome measures
Outcome data not reported
Adverse Events
All Subjects
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place