Dovitinib (TKI258) and Abiraterone Acetate in Metastatic Castrate-Resistant Prostate Cancer (mCRPC)

Prostate Cancer Clinical Trial

Official title: A Phase II Study of Dovitinib (TKI258) Combined With Abiraterone Acetate in Patients With Metastatic Castrate-Resistant Prostate Cancer Evaluating Markers of FGF and AR Signaling in Bone Marrow and Plasma

Status Terminated

Clinical Trial Summary

The goal of this clinical research study is to learn if adding dovitinib to the combination of abiraterone acetate and prednisone may help to control metastatic CRPC. The safety of this drug combination will also be studied.

Clinical Trial Description

Study Drug Administration:

If you are found to be eligible to take part in this study, you will take the study drugs in 28-day cycles.

Dovitinib:

You will take dovitinib capsules by mouth 1 time each day on Days 1-5, 8-12, 15-19, and 22-26 of each cycle. You should take the dovitinib with about a cup (8 ounces) of water. You may take dovitinib with or without food.

If you miss a dose of dovitinib on Days 1-4, 8-11, 15-18, or 22-25, you should not make up the dose on the same day. You should continue taking the drug as scheduled the following day.

If you miss a dose on Days 5, 12, 19, or 26, you should skip the dose, wait 2 days, and start taking dovitinib again as scheduled (on Day 8, 15, 22, or 1 of the next cycle). The study doctor will talk to you about what else you need to do if you miss a dose.

Abiraterone Acetate:

You will take 4 abiraterone acetate tablets by mouth 1 time each day at least 1 hour before a meal or 2 hours after a meal. You should take the abiraterone acetate tablets at about the same time each day and swallow them whole with water. Do not crush or chew the abiraterone acetate tablets.

Prednisone:

You will take 1 tablet of prednisone by mouth 2 times each day (once in the morning, and once in the evening) to help lower the risk of side effects caused by abiraterone acetate.

You should return all unused study drug and/or empty pill bottles to the clinic at the end of each cycle.

If you have side effects, the study doctor may lower the dose of dovitinib and/or abiraterone acetate.

Study Visits:

On Day 1 of every cycle:

• You will have a physical exam.

• Blood (about 3 tablespoons) will be drawn for routine tests, to check your prostatic specific antigen (PSA) levels, and to check how well your blood clots. You must fast for at least 8 hours before this blood draw. On Day 1 of Cycles 2 and 3 only, this blood will also be used for biomarker testing.

• Urine will be collected for routine tests.

On Day 1 of Cycles 1 and 2, and then every odd-numbered cycle afterward (Cycles 3, 5, 7, and so on):

• Blood (about 2 teaspoons) will be drawn for routine tests.

• Urine will be collected to test for markers relating to your bone.

On Day 1 of Cycles 1-3, you will have an EKG.

On Day 1 of Cycle 1, and then on Day 1 of every 3 cycles (Cycles 4, 7, 10, and so on), blood (about 1 tablespoon) will be drawn to test your thyroid function.

On Day 14 of Cycle 1:

• You will have a physical exam.

• Blood (about 3 tablespoons) will be drawn for routine tests and to check how well your blood clots. You must fast for at least 8 hours before this blood draw.

• Urine will be collected for routine tests.

On Day 14 of Cycles 2 and 3, blood (about 1 tablespoon) will be drawn for routine tests.

Every 8 weeks for the first 6 months and every 3 months after that, you will have a chest x-ray, bone scan, and either a CT or MRI scan of your abdomen and pelvis to check the status of the disease.

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.

At Weeks 12 and 24, you will have an echocardiogram or MUGA scan.

Length of Study:

You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You may no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

End-of-Treatment Visit:

Within 4 weeks after your last dose of the study drugs, you will return to the clinic for an end-of-treatment visit. The following tests and procedures will be performed:

• You will have a physical exam.

• Blood (about 3 tablespoons) will be drawn for routine tests and to check your PSA levels. This blood will also be used for biomarker testing. You will need to fast for at least 8 hours before this blood draw.

• Urine will be collected to test for markers relating to your bone. You will have a chest x-ray, bone scan, CT scan, and/or MRI of your abdomen and pelvis to check the status of the disease.

• You will have an EKG and either an echocardiogram or a MUGA scan to check your heart function.

• 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:

The study staff will check up on you to ask how you are doing about every 3 months after your end-of-treatment visit. This update will consist of a phone call, an e-mail, or clinic visit. If contacted by phone, the call would last about 5 minutes.

This is an investigational study. Dovitinib is not FDA approved or commercially available. It is currently being used for research purposes only.

Abiraterone acetate is FDA approved in combination with prednisone for the treatment of metastatic CRPC in patients who have received docetaxel. Its use in this study is investigational.

Prednisone is FDA approved and commercially available as a corticosteroid. It is commonly used with abiraterone acetate.

The study doctor can explain how the study drugs are designed to work.

Up to 60 participants will be enrolled in this study. All will take part at MD Anderson. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT01994590
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Terminated
• Phase: Phase 2
• Start date: May 19, 2014
• Completion date: June 5, 2017