Ponatinib in the Treatment of FGFR Mutation Positive Recurrent or Persistent Endometrial Carcinoma
|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Recruitment Status : Withdrawn (Could not obtain an IDE on the FGFR2 assay)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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888562
|Principal Investigator:||Matthew Powell, M.D.||Washington University School of Medicine|