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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Novartis |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00831792 |
Purpose
Primary Objective:
Secondary Objectives:
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: TK1258 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
| Official Title: | An Observational Study of Continuous TKI258, in Castration-Resistant Prostate Cancer Patients Evaluating Markers of FGF Signaling in Bone Marrow Plasma. |
| Estimated Enrollment: | 40 |
| Study Start Date: | December 2009 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| TK1258: Experimental |
Drug: TK1258
2 Capsules at 100 mg each by mouth twice daily (total of 400 mg per day), 28 day cycle.
|
Show Detailed Description
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Christopher Logothetis, MD | 713-792-2830 |
| United States, Texas | |
| The University of Texas M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Christopher Logothetis, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T.M.D. Anderson Cancer Center ( Christopher Logothetis, MD/Professor ) |
| Study ID Numbers: | 2008-0510 |
| Study First Received: | January 27, 2009 |
| Last Updated: | July 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00831792 History of Changes |
| Health Authority: | United States: Institutional Review Board |
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Prostate Cancer Advanced Prostate Cancer Castrate Resistant Prostate Cancer Prostate Specific Antigen |
PSA Castration-Resistant Prostate Cancer Patients TK1258 CHIR-258 |
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Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |