TKI258 in Castrate Resistant Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00831792|
Recruitment Status : Completed
First Posted : January 29, 2009
Last Update Posted : June 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: TK1258||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Observational Study of Continuous TKI258, in Castration-Resistant Prostate Cancer Patients Evaluating Markers of FGF Signaling in Bone Marrow Plasma|
|Actual Study Start Date :||April 7, 2010|
|Actual Primary Completion Date :||June 12, 2017|
|Actual Study Completion Date :||June 12, 2017|
4 capsules (100 mg/capsules) of TKI 258 by mouth once daily (total of 400 mg of TKI258 per day). Following an initial 4-week cycle at a starting dose of 400 mg 5 days- on and 2 days off, TKI258 may be escalated to 500 mg/day 5 days-on/2 days off if no significant Grade3/4 AEs or laboratory abnormalities are observed.
4 capsules (100 mg/capsules) of TKI 258 by mouth once daily (total of 400 mg of TKI258 per day).
Other Name: CHIR-258
- Patient Overall Survival Time + Early Response Time as Characterized by a Drop in PSA [ Time Frame: Continuously from baseline until disease progression ]Drop in PSA defined by working group criteria.
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): NCT00831792
|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|