Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2025-12-27 @ 7:41 AM
Study NCT ID:
NCT00831792
Status:
COMPLETED
Last Update Posted:
2019-09-11
First Post:
2009-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
TKI258 in Castrate Resistant Prostate Cancer
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
An Observational Study of Continuous TKI258, in Castration-Resistant Prostate Cancer Patients Evaluating Markers of FGF Signaling in Bone Marrow Plasma
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical research study is to learn if a decrease in the levels of prostate specific antigen (PSA) may be linked with the status of prostate cancer that has spread to the bones. Researchers also want to learn how changes in your blood PSA level might affect the rebuilding of healthy bones while you are being treated with TKI258 for prostate cancer.
Detailed Description:
The 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.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take 4 capsules of TKI258 1 time each day for 5 days in a row followed by 2 days of rest (Days 1-5, 8-12, 15-19, and 22-26 of each 28-day study "cycle"). You should take the TKI258 capsules with about 8 ounces of water and at least 1 hour before a meal (breakfast) or at least 2 hours following a meal (breakfast). If you want, you may take the drug with a meal that has fewer than 500 calories and 20 grams of fat.
Study Visits:
Every 28 days makes up 1 study "cycle."
On Day 1 of Cycle 1 and all cycles after that, the following tests and procedures will be performed:
* Your complete medical history will be recorded.
* You will be asked about any drugs or treatments you may be receiving.
* You will be asked about any side effects you may have experienced.
* You will have a physical exam, including measurement of your vital signs and weight.
* Your performance status will be evaluated.
* Blood (about 2 tablespoons) will be collected for routine tests. This blood will also be tested to measure your PSA.
* You will have a triplicate ECG (3 ECGs in a row) before you take the study drug. You will also have 1 ECG about 6 hours after you take the study drug.
On Day 12 (+/- 3 days) of Cycles 1 and 2, and day 26 of Cycle 1 (+/- 3 days) blood (about 1 tablespoon) will be collected for routine tests. Part of the Cycle 2 blood draw will be used to measure the amount of TKI258 in your system. Note that the Day 26 of Cycle 1 visit could end up being scheduled on the same day as the Day 1 of Cycle 2 visit described above.
On Day 1 of Cycle 2 and every odd numbered Cycle after this (Cycles 3, 5, 7and so on), the following tests and procedures will be performed:
* Blood (about 2 teaspoons) will be collected for routine tests.
* Urine will be collected to test for markers relating to your bone.
At the end of every cycle (about Day 26), you will have an ECG.
Every 3 Cycles (about every 12 weeks), the following tests and procedures will be performed:
* Blood (about 1 teaspoon) will be drawn to measure your levels of heart enzymes
* You will have an echocardiogram or MUGA scan like the one you had at the screening visit to check your heart function.
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 every 8 weeks for the first 6 months and every 3 months after that 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:
* You will have a physical exam, including measurement of your vital signs, and weight.
* Your performance status will be evaluated.
* You will be asked about any drugs or treatments you may be receiving.
* You will be asked about any side effects you have experienced since you last visit.
* Blood (about 3 tablespoons) and urine will be collected for routine tests. This blood will also be tested to measure certain hormones, heart enzymes, and PSA.
* You will have a chest x-ray, bone scan, and either a computed tomography (CT) or magnetic resonance imaging (MRI) scan of your abdomen and pelvis to check the status of the disease.
* You will have an ECG and either an echocardiogram or a MUGA scan.
* You will have a bone marrow biopsy and aspiration performed to check the status of the disease and for biomarker testing.
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 MD Anderson.
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.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take 4 capsules of TKI258 1 time each day for 5 days in a row followed by 2 days of rest (Days 1-5, 8-12, 15-19, and 22-26 of each 28-day study "cycle"). You should take the TKI258 capsules with about 8 ounces of water and at least 1 hour before a meal (breakfast) or at least 2 hours following a meal (breakfast). If you want, you may take the drug with a meal that has fewer than 500 calories and 20 grams of fat.
Study Visits:
Every 28 days makes up 1 study "cycle."
On Day 1 of Cycle 1 and all cycles after that, the following tests and procedures will be performed:
* Your complete medical history will be recorded.
* You will be asked about any drugs or treatments you may be receiving.
* You will be asked about any side effects you may have experienced.
* You will have a physical exam, including measurement of your vital signs and weight.
* Your performance status will be evaluated.
* Blood (about 2 tablespoons) will be collected for routine tests. This blood will also be tested to measure your PSA.
* You will have a triplicate ECG (3 ECGs in a row) before you take the study drug. You will also have 1 ECG about 6 hours after you take the study drug.
On Day 12 (+/- 3 days) of Cycles 1 and 2, and day 26 of Cycle 1 (+/- 3 days) blood (about 1 tablespoon) will be collected for routine tests. Part of the Cycle 2 blood draw will be used to measure the amount of TKI258 in your system. Note that the Day 26 of Cycle 1 visit could end up being scheduled on the same day as the Day 1 of Cycle 2 visit described above.
On Day 1 of Cycle 2 and every odd numbered Cycle after this (Cycles 3, 5, 7and so on), the following tests and procedures will be performed:
* Blood (about 2 teaspoons) will be collected for routine tests.
* Urine will be collected to test for markers relating to your bone.
At the end of every cycle (about Day 26), you will have an ECG.
Every 3 Cycles (about every 12 weeks), the following tests and procedures will be performed:
* Blood (about 1 teaspoon) will be drawn to measure your levels of heart enzymes
* You will have an echocardiogram or MUGA scan like the one you had at the screening visit to check your heart function.
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 every 8 weeks for the first 6 months and every 3 months after that 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:
* You will have a physical exam, including measurement of your vital signs, and weight.
* Your performance status will be evaluated.
* You will be asked about any drugs or treatments you may be receiving.
* You will be asked about any side effects you have experienced since you last visit.
* Blood (about 3 tablespoons) and urine will be collected for routine tests. This blood will also be tested to measure certain hormones, heart enzymes, and PSA.
* You will have a chest x-ray, bone scan, and either a computed tomography (CT) or magnetic resonance imaging (MRI) scan of your abdomen and pelvis to check the status of the disease.
* You will have an ECG and either an echocardiogram or a MUGA scan.
* You will have a bone marrow biopsy and aspiration performed to check the status of the disease and for biomarker testing.
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 MD Anderson.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2011-01106 | REGISTRY | NCI CTRP | View |