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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.
|
Hide Detailed DescriptionThe Study Drug:
TKI258 is designed to perform several anti-tumor functions, including cutting off the blood supply to tumors. Researchers think this may help slow or stop the growth of prostate cancer.
Screening Tests:
Signing this consent form does not mean that you will be able to take part in this study. You will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed within 30 days before you begin taking the study drug:
The following tests and procedures will be performed within 14 days before you begin taking the study drug:
The study doctor will discuss the screening test results with you. If the screening tests show that you are not eligible to take part in the study, you will not be enrolled. Other treatment options will be discussed with you.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take 2 capsules of TKI258 2 times each day (4 total capsules each day) while you are on study.
Study Visits:
Every 28 days makes up 1 study "cycle."
On Day 1 of Cycles 1, 2, and every evenly numbered Cycle after this (Cycles 4, 6, and so on), the following tests and procedures will be performed:
About 7-10 weeks after your first dose of study drug, you will have another bone marrow biopsy and aspiration performed to check the status of the disease and for biomarker testing.
CT and/or bone scans will be performed whenever the study doctor thinks they are needed to check the status of the disease.
Length of Study:
You may remain on study for as long as you are benefiting. You will be taken off study if intolerable side effects occur or if the disease gets worse.
End-of-Study Visit:
Within 4 weeks after your last dose of the study drug, you will return to the clinic for an end-of-study visit. The following tests and procedures will be performed:
Long-Term Follow-up:
Once you are no longer on this study, the research staff will check up on you about every 3 months. This update will consist of a phone call, an e-mail, or a review of your medical and/or other records. You will not have any extra tests, procedures, or study visits. If contacted by phone, the call would only last about 5 minutes.
THIS IS AN INVESTIGATIONAL STUDY. TKI258 is not FDA approved or commercially available. It is being used in this study for research purposes only.
Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.
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 |
|
Prostate Cancer Advanced Prostate Cancer Castrate Resistant Prostate Cancer Prostate Specific Antigen |
PSA Castration-Resistant Prostate Cancer Patients TK1258 CHIR-258 |
|
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |