Ponatinib in the Treatment of FGFR Mutation Positive Recurrent or Persistent Endometrial Carcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01888562|
Recruitment Status : Withdrawn (Could not obtain an IDE on the FGFR2 assay)
First Posted : June 27, 2013
Last Update Posted : December 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Neoplasms||Drug: Ponatinib||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Evaluation of Ponatinib (AP24534), a Potent Oral Pan-FGFR Inhibitor, in the Treatment of FGFR Mutation Positive Recurrent or Persistent Endometrial Carcinoma: a Multi-Institutional Study|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2023|
Ponatinib 45mg po daily for 4 weeks (4 weeks equal 1 cycle).
Ponatinib 45 mg daily for 4 weeks (4 weeks equal one cycle)
Other Name: Iclusig™
- Tumor responses (CR + PR) [ Time Frame: 6 months ]
Ponatinib in patients with recurrent or persistent endometrioid endometrial cancer (FGFR2 activating mutation positive)for tumor responses (CR + PR)
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
- Progression Free survival [ Time Frame: 6 months ]
Ponatinib in patients with recurrent or persistent endometrioid endometrial cancer (FGFR2 activating mutation positive) by evaluating progression-free survival
Progression-free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
- Progression Free Survival [ Time Frame: 5.5 years ]Progression Free Survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
- overall survival [ Time Frame: 5.5 years ]Overall survival is define as date from time of initial treatment to date of death from any cause.
- Toxicity of Ponatinib [ Time Frame: 1 year ]Frequency and severity as defined by CTCAE v 4.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888562
|Principal Investigator:||Matthew Powell, M.D.||Washington University School of Medicine|