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
|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|