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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: January 27, 2012 to July 29, 2014. All recruitment done at The University of Texas MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Dovitinib 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.

Participant Flow:   Overall Study
    Dovitinib
STARTED   22 
COMPLETED   17 
NOT COMPLETED   5 
Adverse Event                1 
Withdrawal by Subject                3 
Protocol Violation                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Dovitinib 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.

Baseline Measures
   Dovitinib 
Overall Participants Analyzed 
[Units: Participants]
 22 
Age 
[Units: Years]
Median (Full Range)
 56 
 (29 to 70) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      22 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   22 


  Outcome Measures

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: CR_Study_Registration@mdanderson.org



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