TKI258 for Metastatic Inflammatory Breast Cancer Patients

Breast Cancer Clinical Trial

Official title: A Phase II Study of TKI258 (Dovitinib Lactate) as Salvage Therapy in Patients With Stage IV HER2-negative Inflammatory Breast Cancer (IBC) and Local or Distant Relapse

Status Completed

Clinical Trial Summary

The goal of this clinical research study is to learn if dovitinib can help to control inflammatory breast cancer. The safety of this drug will also be studied.

Clinical Trial Description

The Study Drug:

Dovitinib is designed bind to a protein on the surface of cancer cells called the FGF receptor. This may slow the growth of cancer cells or kill cancer cells.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will take dovitinib by mouth each day for 5 days and have a 2-day rest period (5 days on/2 days off schedule). The first dose of each week is Day 1. You should take dovitinib in the morning with a glass (about 8 ounces) of water at least 1 hour before or at least 2 hours after eating. It is important that you take the study drug at about the same time every day.

If you forget to take a dose of the study drug as scheduled, or take a dose during your 2-day rest period, you should follow the guidelines below or call your study staff:

• If you take a dose on Day 6, then you will rest on Day 7 and start taking the drug on Day 1.

• If you take a dose on Day 7, then you will skip Day 1 the next schedule and start dosing on Day 2.

• If you take a dose on Day 6 and Day 7, then you will skip Days 1 and 2 of the next schedule and start dosing on Day 3.

• If you missed a dose on Days 1, 2, 3, or 4, you should restart the next dosing day and rest on Days 6 and 7.

• If you missed a dose on Day 5, you should rest on Days 6 and 7, and restart dosing on Day 1 of the next week.

You should not take additional medications including over-the-counter products and herbal/alternative medications during the study without asking your doctor. It is important to avoid medications that are known to cause liver side effects.

If you experience intolerable side effects, the study doctor may give you drugs to help control the side effects.

You should store the study drug at room temperature and out of direct sunlight. The study drug should also be kept away from children.

About every 4 weeks, you will need to bring back your empty or partially used bottles of study drug.

During Treatment:

At every visit, you will be asked if you have had any side effects.

Before each Cycle:

• You will have a physical exam, including measurement of your vital signs.

• Your performance status will be recorded.

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

Cycle 1, around Days 8 and 22:

° Blood (about 1 tablespoon) will be drawn to check your liver function.

Cycle 2 around Day 8:

° Blood (about 1 tablespoon) will be drawn to check your liver function.

Every 2 cycles (before Cycles 3, 5, 7, and so on):

• If the doctor thinks it is needed, photographs will be taken of your skin and any areas affected by inflammatory breast cancer.

• If the doctor thinks it is needed, you will have x-rays, a CT scan of the chest and/or abdomen, and/or a bone scan.

Before Cycle 3:

• If the doctor thinks it is needed, you will have a positron emission computed tomography (PET/CT) scan to check the status of the disease.

• Blood (about 2 tablespoons) will be drawn for biomarker testing.

You will also have a one-time blood draw (about 1 tablespoon) to measure the level of the study drug in your blood. This sample may be drawn on Days 12 or 26 of Cycle 1, before Cycle 2, or on Day 12 of Cycle 2.

If the doctor thinks it is needed, any of these tests and procedures may be performed earlier. If the doctor thinks it is needed, you will have an ECG, ECHO, or MUGA scan to check your heart function.

Length of Study:

You may remain on study for as long as you are benefiting. You will be taken off study treatment if the disease gets worse or you experience intolerable side effects.

Your participation on the study will be over once you have completed the end-of-treatment visit.

End-of-Treatment Visit:

After you are off study, you will have a end-of-treatment visit within 14 days after the last study visit.

• You will be asked if you have had any side effects.

• You will have a physical exam, including measurement of your vital signs.

• Your performance status will be recorded.

• Blood (about 1 tablespoon) will be drawn for routine tests.

• If the doctor thinks it is needed, photographs will be taken of your skin and any areas affected by inflammatory breast cancer.

• If the doctor thinks it is needed, you will have x-rays, a CT scan of the chest and/or abdomen, and/or a bone scan.

• If the doctor thinks it is needed, you will have an ECG and ECHO or MUGA scan to check your heart function.

• If the doctor thinks it is needed, you will have a PET/CT scan to check the status of the disease.

Follow-up Visits:

You will be called or e-mailed every 3 months for up to 1 year and asked how you are doing.

This is an investigational study. Dovitinib is not FDA approved or commercially available. At this time, dovitinib is only being used in research.

Up to 33 patients will take part in this study. All will be enrolled at MD Anderson. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT01262027
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: Phase 2
• Start date: January 27, 2012
• Completion date: November 25, 2015