Trial Outcomes & Findings for Dovitinib (TKI258) and Abiraterone Acetate in Metastatic Castrate-Resistant Prostate Cancer (mCRPC) (NCT NCT01994590)
NCT ID: NCT01994590
Last Updated: 2019-03-19
Results Overview
Number of Participants with Adverse Events
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
Participants are followed while actively taking study drug and for at least 30 days post last dose.
Results posted on
2019-03-19
Participant Flow
Participant milestones
| Measure |
All Patients
Dovitinib combined with abiraterone and prednisone
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
All Patients
Dovitinib combined with abiraterone and prednisone
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Trial Terminated
|
1
|
Baseline Characteristics
Dovitinib (TKI258) and Abiraterone Acetate in Metastatic Castrate-Resistant Prostate Cancer (mCRPC)
Baseline characteristics by cohort
| Measure |
All Patients
n=4 Participants
Dovitinib combined with abiraterone and prednisone
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
71.25 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants are followed while actively taking study drug and for at least 30 days post last dose.Number of Participants with Adverse Events
Outcome measures
| Measure |
All Patients
n=4 Participants
Dovitinib combined with abiraterone and prednisone
|
|---|---|
|
Safety and Tolerability
|
4 Participants
|
Adverse Events
All Patients
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Patients
n=4 participants at risk
Dovitinib combined with abiraterone and prednisone
|
|---|---|
|
Blood and lymphatic system disorders
Thromboembolic Event
|
25.0%
1/4 • First study drug dose, until 30 days after the last dose of study drug, unless the participant withdraws consent
|
|
Skin and subcutaneous tissue disorders
Skin Infection
|
25.0%
1/4 • First study drug dose, until 30 days after the last dose of study drug, unless the participant withdraws consent
|
Other adverse events
| Measure |
All Patients
n=4 participants at risk
Dovitinib combined with abiraterone and prednisone
|
|---|---|
|
Hepatobiliary disorders
Alanine aminotransferase increased
|
50.0%
2/4 • First study drug dose, until 30 days after the last dose of study drug, unless the participant withdraws consent
|
|
Hepatobiliary disorders
Alkaline phophatase increased
|
50.0%
2/4 • First study drug dose, until 30 days after the last dose of study drug, unless the participant withdraws consent
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
2/4 • First study drug dose, until 30 days after the last dose of study drug, unless the participant withdraws consent
|
|
Hepatobiliary disorders
Aspartate aminotransferase increase
|
75.0%
3/4 • First study drug dose, until 30 days after the last dose of study drug, unless the participant withdraws consent
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
2/4 • First study drug dose, until 30 days after the last dose of study drug, unless the participant withdraws consent
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
1/4 • First study drug dose, until 30 days after the last dose of study drug, unless the participant withdraws consent
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
1/4 • First study drug dose, until 30 days after the last dose of study drug, unless the participant withdraws consent
|
|
Metabolism and nutrition disorders
Fatigue
|
100.0%
4/4 • First study drug dose, until 30 days after the last dose of study drug, unless the participant withdraws consent
|
|
Renal and urinary disorders
Hematuria
|
25.0%
1/4 • First study drug dose, until 30 days after the last dose of study drug, unless the participant withdraws consent
|
|
Vascular disorders
Hot flashes
|
25.0%
1/4 • First study drug dose, until 30 days after the last dose of study drug, unless the participant withdraws consent
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • First study drug dose, until 30 days after the last dose of study drug, unless the participant withdraws consent
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
2/4 • First study drug dose, until 30 days after the last dose of study drug, unless the participant withdraws consent
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.0%
1/4 • First study drug dose, until 30 days after the last dose of study drug, unless the participant withdraws consent
|
|
Metabolism and nutrition disorders
Hypomagnesium
|
50.0%
2/4 • First study drug dose, until 30 days after the last dose of study drug, unless the participant withdraws consent
|
|
Vascular disorders
Hypotension
|
25.0%
1/4 • First study drug dose, until 30 days after the last dose of study drug, unless the participant withdraws consent
|
|
Blood and lymphatic system disorders
Localized edema
|
25.0%
1/4 • First study drug dose, until 30 days after the last dose of study drug, unless the participant withdraws consent
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
25.0%
1/4 • First study drug dose, until 30 days after the last dose of study drug, unless the participant withdraws consent
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
75.0%
3/4 • First study drug dose, until 30 days after the last dose of study drug, unless the participant withdraws consent
|
|
Renal and urinary disorders
Proteinuria
|
25.0%
1/4 • First study drug dose, until 30 days after the last dose of study drug, unless the participant withdraws consent
|
|
Vascular disorders
Thromboembolic event
|
25.0%
1/4 • First study drug dose, until 30 days after the last dose of study drug, unless the participant withdraws consent
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
50.0%
2/4 • First study drug dose, until 30 days after the last dose of study drug, unless the participant withdraws consent
|
|
Renal and urinary disorders
Urinary tract infection
|
25.0%
1/4 • First study drug dose, until 30 days after the last dose of study drug, unless the participant withdraws consent
|
|
Renal and urinary disorders
Urinary urgency
|
25.0%
1/4 • First study drug dose, until 30 days after the last dose of study drug, unless the participant withdraws consent
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
25.0%
1/4 • First study drug dose, until 30 days after the last dose of study drug, unless the participant withdraws consent
|
Additional Information
Corn,Paul,M.D. Ph.D. / Genitourinary Medical Oncology
UT MD Anderson Cancer Center
Phone: 713-792-2830
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place