Clinical Trial: Ponatinib in the Treatment of FGFR Mutation Positive Recurrent or Persistent Endometrial Carcinoma

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

Brief Summary: To test the patient's cancerous tumor to see if it has a FGFR mutation and, if so, to see how their cancer responds to a treatment with the drug ponatinib as well as examine the side effects caused by ponatinib.

Detailed Summary:
Sponsor: Washington University School of Medicine

Current Primary Outcome:

  • 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.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Washington University School of Medicine

Dates:
Date Received: June 25, 2013
Date Started: January 2016
Date Completion: July 2023
Last Updated: December 17, 2015
Last Verified: December 2015