Trial Outcomes & Findings for Alisertib, Abiraterone Acetate and Prednisone in Treating Patients With Hormone-Resistant Prostate Cancer (NCT NCT01848067)
NCT ID: NCT01848067
Last Updated: 2025-05-04
Results Overview
Summarized with descriptive statistics.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Up to 21 days
Results posted on
2025-05-04
Participant Flow
Participant milestones
| Measure |
Treatment (Alisertib, Abiraterone Acetate, Prednisone)
Patients receive alisertib PO BID on days 1-7, abiraterone acetate PO daily, and prednisone PO BID. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Alisertib: Given PO
Abiraterone acetate: Given PO
Prednisone: Given PO
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Alisertib, Abiraterone Acetate and Prednisone in Treating Patients With Hormone-Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Alisertib, Abiraterone Acetate, Prednisone)
n=9 Participants
Patients receive alisertib PO BID on days 1-7, abiraterone acetate PO daily, and prednisone PO BID. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Alisertib: Given PO
Abiraterone acetate: Given PO
Prednisone: Given PO
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 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
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 21 daysSummarized with descriptive statistics.
Outcome measures
| Measure |
Treatment (Alisertib, Abiraterone Acetate, Prednisone)
n=9 Participants
Patients receive alisertib PO BID on days 1-7, abiraterone acetate PO daily, and prednisone PO BID. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Alisertib: Given PO
Abiraterone acetate: Given PO
Prednisone: Given PO
|
|---|---|
|
Phase I: Frequency of Dose Limiting Toxicities of Alisertib, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.1
|
2 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The toxicity / efficacy ratio did not warrant further pursuing this treatment and the trial was terminated earlier after discussion with sponsor. Trial did not progress to Phase II.
The Kaplan-Meier product limit method will be used to estimate the probability distribution of progression free survival (PFS). The proportion of patients achieving at least a 50% decline from baseline will be reported with a 95% confidence interval. The results will be presented graphically using a waterfall plot.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 3 monthsCompared between the two patient subsets using the nonparametric Mann-Whitney test. A comparison of CTC counts between baseline and at progression for those who have progressed will be carried out using either a paired t test or the nonparameteric Wilcoxon matched pairs test.
Outcome measures
| Measure |
Treatment (Alisertib, Abiraterone Acetate, Prednisone)
n=9 Participants
Patients receive alisertib PO BID on days 1-7, abiraterone acetate PO daily, and prednisone PO BID. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Alisertib: Given PO
Abiraterone acetate: Given PO
Prednisone: Given PO
|
|---|---|
|
Number of Participants With a PSA Value Equal to or Greater Than 25%
|
3 Participants
|
Adverse Events
Treatment (Alisertib, Abiraterone Acetate, Prednisone)
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Alisertib, Abiraterone Acetate, Prednisone)
n=9 participants at risk
Patients receive alisertib PO BID on days 1-7, abiraterone acetate PO daily, and prednisone PO BID. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Alisertib: Given PO
Abiraterone acetate: Given PO
Prednisone: Given PO
|
|---|---|
|
Blood and lymphatic system disorders
Neutrophil Count Decreased
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Nervous system disorders
Memory Loss
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Immune system disorders
White blood cell count decreased
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Immune system disorders
Mucositis
|
11.1%
1/9 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
Treatment (Alisertib, Abiraterone Acetate, Prednisone)
n=9 participants at risk
Patients receive alisertib PO BID on days 1-7, abiraterone acetate PO daily, and prednisone PO BID. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Alisertib: Given PO
Abiraterone acetate: Given PO
Prednisone: Given PO
|
|---|---|
|
Blood and lymphatic system disorders
Hyperglycemia
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
gastroesophogeal reflux disease (GERD)
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Immune system disorders
Mucositis
|
22.2%
2/9 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
General disorders
Mouth Sore
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
General disorders
Dehydration
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Immune system disorders
WBC decreased
|
33.3%
3/9 • Number of events 3 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
55.6%
5/9 • Number of events 5 • 2 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
General disorders
Dizziness
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
General disorders
Dysphagia
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
General disorders
Tongue Swelling
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Neutrophil Count decreased
|
22.2%
2/9 • Number of events 2 • 2 years
|
Additional Information
Dr. Jianqing Lin
Sidney Kimmel Cancer Center at Thomas Jefferson University
Phone: (215) 955-8874
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place