Dovitinib (TKI258) and Abiraterone Acetate in Metastatic Castrate-Resistant Prostate Cancer (mCRPC)
|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
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Dovitinib Drug: Abiraterone Acetate Drug: Prednisone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Dovitinib (TKI258) Combined With Abiraterone Acetate in Patients With Metastatic Castrate-Resistant Prostate Cancer Evaluating Markers of FGF and AR Signaling in Bone Marrow and Plasma|
|Actual Study Start Date :||May 19, 2014|
|Actual Primary Completion Date :||June 5, 2017|
|Actual Study Completion Date :||June 5, 2017|
Experimental: Dovitinib + Abiraterone Acetate + Prednisone
Participants receive a single daily oral dose of Dovitinib for 5 consecutive days, on Days 1-5, 8-12, 15-19, and 22-26 of each 28 day cycle. Starting dose will be 400 mg daily.
Participant to take 4 tablets (250 mg each) orally (PO) daily of Abiraterone acetate.
Participant to take 5 mg oral prednisone, twice daily.
Starting dose will be 400 mg by mouth daily on Days 1-5, 8-12, 15-19, and 22-26 of each 28 day cycle.
Other Name: TKI258
Drug: Abiraterone Acetate
4 tablets (250 mg each) by mouth daily.
Other Name: Zytiga
5 mg by mouth twice daily.
- Safety and Tolerability [ Time Frame: Participants are followed while actively taking study drug and for at least 30 days post last dose. ]Number of Participants with Adverse Events
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994590
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Paul Corn, MD,PHD||M.D. Anderson Cancer Center|