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A Phase II Study to Evaluate the Efficacy of TKI258 for the Treatment of Patients With FGFR2 Mutated or Wild-type Advanced and/or Metastatic Endometrial Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01379534
First received: June 6, 2011
Last updated: May 2, 2015
Last verified: May 2015
Results First Received: March 18, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Solid Tumors and Advanced Endometrial Cancer
Endometrial Cancer
Second-line Treatment
VEGF
Intervention: Drug: TKI258

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were treated with TKI258 until disease progression, unacceptable toxicity, death or discontinuation due to any other reason. All participants were followed for at least 30 days after their last dose of study drug for safety assessment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
If a participant didn’t discontinue study drug due to disease progression, death, lost to follow-up or withdrawn consent to post treatment tumor assessment, then tumor assessments continued every 6 weeks until the start of new anti-cancer therapy, disease progression, death, lost to follow-up or withdrawn consent to tumor status follow-up.

Reporting Groups
  Description
FGFR2 (MUT) Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
FGFR2 (WT) Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.

Participant Flow for 2 periods

Period 1:   Treatment Phase
    FGFR2 (MUT)   FGFR2 (WT)
STARTED   22   31 
COMPLETED   0   0 
NOT COMPLETED   22   31 
Withdrawal by Subject                2                2 
Progressive disease                13                22 
Adverse Event                7                7 

Period 2:   Tumor Assessment Follow-up (f/u) Phase
    FGFR2 (MUT)   FGFR2 (WT)
STARTED   4 [1]   2 
COMPLETED   0   0 
NOT COMPLETED   4   2 
Death                0                1 
Progressive disease                3                0 
Lost to Follow-up                0                1 
Adverse Event                1                0 
[1] All participants discontinued the Treatment Phase. Of these, only 6 qualified for f/u tumor assess..



  Baseline Characteristics
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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
FGFR2 (MUT) Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
FGFR2 (WT) Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
Total Total of all reporting groups

Baseline Measures
   FGFR2 (MUT)   FGFR2 (WT)   Total 
Overall Participants Analyzed 
[Units: Participants]
 22   31   53 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.9  (10.54)   64.4  (8.63)   63.4  (9.45) 
Gender, Customized [1] 
[Units: Participants]
 22   31   53 
[1] Females only


  Outcome Measures
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1.  Primary:   Progression Free Survival (PFS) Rate   [ Time Frame: up to 18 weeks ]

2.  Secondary:   Overall Response Rate (ORR)   [ Time Frame: Baseline and every 6 weeks until disease progression, up to 18 weeks ]

3.  Secondary:   Disease Control Rate (DCR)   [ Time Frame: Baseline and every 6 weeks until disease progression, up to 18 weeks ]

4.  Secondary:   Duration of Response (DR)   [ Time Frame: up to 18 weeks ]

5.  Secondary:   Overall Survival (OS)   [ Time Frame: up to 18 weeks ]

6.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: up to 18 weeks ]

7.  Secondary:   Number of Participants With Adverse Events, Serious Adverse Events and Deaths   [ Time Frame: up to 30 days after the last dose of study drug, up to 18 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis
phone: 862-778-8300


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01379534     History of Changes
Other Study ID Numbers: CTKI258A2211
2011-000266-35 ( EudraCT Number )
Study First Received: June 6, 2011
Results First Received: March 18, 2015
Last Updated: May 2, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Germany: Federal Institutes for Drugs and Medical Devices (BfArM)
Netherlands: Medicines Evaluation Board
Singapore: Health Science Authority
Italy: Italian Medicines Agency (AIFA)