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TKI258 for Metastatic Inflammatory Breast Cancer Patients

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ClinicalTrials.gov Identifier: NCT01262027
Recruitment Status : Active, not recruiting
First Posted : December 17, 2010
Results First Posted : February 2, 2017
Last Update Posted : June 15, 2017
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Intervention Drug: Dovitinib
Enrollment 22
Recruitment Details Recruitment Period: January 27, 2012 to July 29, 2014. All recruitment done at The University of Texas MD Anderson Cancer Center.
Pre-assignment Details  
Arm/Group Title Dovitinib
Hide Arm/Group Description Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.
Period Title: Overall Study
Started 22
Completed 17
Not Completed 5
Reason Not Completed
Adverse Event             1
Withdrawal by Subject             3
Protocol Violation             1
Arm/Group Title Dovitinib
Hide Arm/Group Description Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.
Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 22 participants
56
(29 to 70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
22
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants
22
1.Primary Outcome
Title Overall Response (Complete Response [CR], Partial Response [PR] or Stable Disease [SD]) of Participants
Hide Description 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
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Three participants were not evaluable for response due to early departure from study.
Arm/Group Title Dovitinib
Hide Arm/Group Description:
Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: participants
Complete Response (CR) 0
Partial Response (PR) 0
Stable Disease (SD) 1
2.Secondary Outcome
Title Safety Analysis of Dovitinib: Most Frequently Reported Treatment-related Adverse Event (AEs)
Hide Description 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.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluation included all participants.
Arm/Group Title Dovitinib
Hide Arm/Group Description:
Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: percentage of participants
Grade 3 & 4: Fatigue 28
Grade 3 & 4: Pain 28
Time Frame Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dovitinib
Hide Arm/Group Description Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.
All-Cause Mortality
Dovitinib
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dovitinib
Affected / at Risk (%) # Events
Total   0/22 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dovitinib
Affected / at Risk (%) # Events
Total   20/22 (90.91%)    
Cardiac disorders   
Chest wall pain  1  1/22 (4.55%)  1
Ejection fraction decreased  1  1/22 (4.55%)  1
Gastrointestinal disorders   
Abdominal pain  1  3/22 (13.64%)  3
Constipation  1  1/22 (4.55%)  1
Diarrhea  1  7/22 (31.82%)  7
Dyspnea  1  2/22 (9.09%)  2
Nausea  1  12/22 (54.55%)  12
Vomiting  1  8/22 (36.36%)  9
General disorders   
Edema face  1  1/22 (4.55%)  1
Fatigue  1  11/22 (50.00%)  17
Neck pain  1  1/22 (4.55%)  1
Oral pain  1  1/22 (4.55%)  1
Infections and infestations   
Bladder infection  1  1/22 (4.55%)  1
Infections and infestations - Sinus  1  2/22 (9.09%)  2
Investigations   
Alkaline phosphatase increased  1  1/22 (4.55%)  1
Blood bilirubin increased  1  1/22 (4.55%)  1
Weight loss  1  1/22 (4.55%)  1
Metabolism and nutrition disorders   
Anorexia  1  2/22 (9.09%)  2
Dehydration  1  1/22 (4.55%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia  1  2/22 (9.09%)  2
Back pain  1  3/22 (13.64%)  3
Myalgia  1  1/22 (4.55%)  2
Pain in extremity  1  2/22 (9.09%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified - Disease Progression  1  1/22 (4.55%)  1
Nervous system disorders   
Headache  1  1/22 (4.55%)  1
Paresthesia  1  2/22 (9.09%)  2
Stroke  1  1/22 (4.55%)  1
Renal and urinary disorders   
Urinary tract infection  1  1/22 (4.55%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  2/22 (9.09%)  2
Mucositis oral  1  1/22 (4.55%)  1
Sore throat  1  1/22 (4.55%)  1
Skin and subcutaneous tissue disorders   
Rash acneiform  1  1/22 (4.55%)  1
Rash maculo-papular  1  2/22 (9.09%)  2
Vascular disorders   
Hypertension  1  1/22 (4.55%)  1
Hypotension  1  1/22 (4.55%)  1
Thromboembolic event  1  2/22 (9.09%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Vicente Valero, MD/Professor, Breast Medical Oncology
Organization: The University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-7734
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01262027     History of Changes
Other Study ID Numbers: 2010-0296
NCI-2011-00299 ( Registry Identifier: NCI CTRP )
First Submitted: December 15, 2010
First Posted: December 17, 2010
Results First Submitted: December 8, 2016
Results First Posted: February 2, 2017
Last Update Posted: June 15, 2017