Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

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).

TK1258

Paul Corn, MD, PHD

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.

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 in Castrate Resistant Prostate Cancer

An Observational Study of Continuous TKI258, in Castration-Resistant Prostate Cancer Patients Evaluating Markers of FGF Signaling in Bone Marrow Plasma

Three consecutive PSA elevations above nadir or baseline are required for progression. Each increment in PSA should be a minimum of 1 ng/ml and at least 2 weeks apart or will not count. The time of PSA progression will be taken as the time of the first of these PSA elevations that represents an increment by at least 25% above the nadir or baseline. Given that increments in PSA do not always represent treatment failure, particularly when novel agents with uncertain effects on PSA levels are being evaluated, clinical and radiological correlation is recommended at the discretion of the treating physician. In patients with PSA progression alone without clinical or radiological evidence of disease progression, continued therapy on study is at the discretion of the treating physician in consultation with the principal investigator.

Novartis

M.D. Anderson Cancer Center

Patients with castrate-resistant prostate cancer

All Patients Enrolled and Treated With TKI 258

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Corn,Paul,M.D. Ph.D. / Genitourinary Medical Oncology

Patients with histologically confirmed adenocarcinoma of the prostate with bone metastases

APatients on Observational Study of TKI258

Patients completed at least 1 cycle of therapy

The Number of Participants With Improvement, Disease Progression or Stable Disease

All patients enrolled and treated with TKI 258

Spots Global Cancer Trial Database for tk1258

Every month we try and update this database with for tk1258 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
TKI258 in Castrate Resistant Prostate Cancer	NCT00831792	Prostate Cancer	TK1258	-	M.D. Anderson Cancer Center
TKI258 in Castrate Resistant Prostate Cancer	NCT00831792	Prostate Cancer	TK1258	-	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for tk1258

Every month we try and update this database with for tk1258 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tk1258 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.