Clinical Trial: TKI258 for Metastatic Inflammatory Breast Cancer Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:

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 ask
Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: Overall Response (Complete Response [CR], Partial Response [PR] or Stable Disease [SD]) of Participants [ Time Frame: 6 months ]

Number of participants experiencing CR, PR or SD as defined by Response Evaluation Criteria In Solid Tumors (RECIST). Response is anyone who experiences SD, CR or PR in first 6 months. CR: Disappearance clinical evidence active tumor by evaluation, mammogram & ultrasound. No symptoms or evidence of residual invasive tumor, including no residual tumor in axillary lymph nodes. PR: 50%/> decrease for minimum 4 weeks in measurable lesion determined by product of perpendicular diameters of lesion. Every lesion should not regress to qualify as PR; however, if lesion progresses or if new lesions appear, response cannot be classified as PR. Minor Response [MR]: Decreases in tumor masses insufficient to qualify as partial remission, i.e. <50%. SD: Between MR & PD. PD: Increase 25% measured lesion from baseline. New lesions constitutes increasing disease. Mixed responses consid


Original Primary Outcome: Overall Response Rate [ Time Frame: 6 months ]

Current Secondary Outcome: Safety Analysis of Dovitinib: Most Frequently Reported Treatment-related Adverse Event (AEs) [ Time Frame: 6 months ]

Safety analysis evaluated by grading each adverse event according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and reporting the type, frequency and severity in a summary format. Full AE reporting can be found in the Adverse Event Section.


Original Secondary Outcome:

Information By: M.D. Anderson Cancer Center

Dates:
Date Received: December 15, 2010
Date Started: January 2012
Date Completion:
Last Updated: December 8, 2016
Last Verified: December 2016