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Trial record 30 of 48 for:    Dovitinib

Dovitinib (TKI258) and Abiraterone Acetate in Metastatic Castrate-Resistant Prostate Cancer (mCRPC)

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ClinicalTrials.gov Identifier: NCT01994590
Recruitment Status : Terminated (Sponsor stopped supplying study drug)
First Posted : November 26, 2013
Results First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Drug: Dovitinib
Drug: Abiraterone Acetate
Drug: Prednisone
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Patients
Hide Arm/Group Description Dovitinib combined with abiraterone and prednisone
Period Title: Overall Study
Started 4
Completed 2
Not Completed 2
Reason Not Completed
Adverse Event             1
Trial Terminated             1
Arm/Group Title All Patients
Hide Arm/Group Description Dovitinib combined with abiraterone and prednisone
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
0
   0.0%
>=65 years
4
 100.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants
71.25
(66 to 73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
0
   0.0%
Male
4
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
0
   0.0%
Unknown or Not Reported
4
 100.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
 100.0%
1.Primary Outcome
Title Safety and Tolerability
Hide Description Number of Participants with Adverse Events
Time Frame Participants are followed while actively taking study drug and for at least 30 days post last dose.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
Dovitinib combined with abiraterone and prednisone
Overall Number of Participants Analyzed 4
Measure Type: Count of Participants
Unit of Measure: Participants
4
Time Frame First study drug dose, until 30 days after the last dose of study drug, unless the participant withdraws consent
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Patients
Hide Arm/Group Description Dovitinib combined with abiraterone and prednisone
All-Cause Mortality
All Patients
Affected / at Risk (%)
Total   0/4 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
All Patients
Affected / at Risk (%)
Total   1/4 (25.00%) 
Blood and lymphatic system disorders   
Thromboembolic Event  1  1/4 (25.00%) 
Skin and subcutaneous tissue disorders   
Skin Infection  1  1/4 (25.00%) 
1
Term from vocabulary, CTCAE v4.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Patients
Affected / at Risk (%)
Total   4/4 (100.00%) 
Blood and lymphatic system disorders   
Anemia  1  2/4 (50.00%) 
Localized edema  1  1/4 (25.00%) 
Neutrophil count decreased  1  1/4 (25.00%) 
Platelet count decreased  1  3/4 (75.00%) 
White blood cell decreased  1  1/4 (25.00%) 
Gastrointestinal disorders   
Diarrhea  1  2/4 (50.00%) 
Hepatobiliary disorders   
Alanine aminotransferase increased  1  2/4 (50.00%) 
Alkaline phophatase increased  1  2/4 (50.00%) 
Aspartate aminotransferase increase  1  3/4 (75.00%) 
Metabolism and nutrition disorders   
Fatigue  1  4/4 (100.00%) 
Hypoalbuminemia  1  2/4 (50.00%) 
Hypokalemia  1  1/4 (25.00%) 
Hypomagnesium  1  2/4 (50.00%) 
Renal and urinary disorders   
Hematuria  1  1/4 (25.00%) 
Proteinuria  1  1/4 (25.00%) 
Urinary tract infection  1  1/4 (25.00%) 
Urinary urgency  1  1/4 (25.00%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/4 (25.00%) 
Upper respiratory infection  1  2/4 (50.00%) 
Skin and subcutaneous tissue disorders   
Dry skin  1  1/4 (25.00%) 
Vascular disorders   
Hot flashes  1  1/4 (25.00%) 
Hypertension  1  1/4 (25.00%) 
Hypotension  1  1/4 (25.00%) 
Thromboembolic event  1  1/4 (25.00%) 
1
Term from vocabulary, CTCAE v4.0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Corn,Paul,M.D. Ph.D. / Genitourinary Medical Oncology
Organization: UT MD Anderson Cancer Center
Phone: 713-792-2830
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01994590     History of Changes
Other Study ID Numbers: 2013-0086
NCI-2014-00887 ( Registry Identifier: NCI CTRP )
First Submitted: November 19, 2013
First Posted: November 26, 2013
Results First Submitted: April 30, 2018
Results First Posted: March 19, 2019
Last Update Posted: March 19, 2019