There are 2 clinical trials
An open-label, non-randomized, single arm study to assess the safety, tolerability, and pharmacokinetics of FP-1039 given by weekly intravenous (IV) administrations in advanced endometrial cancer patients with FGFR2-specific mutations. FP-1039 will be dosed weekly starting at a dose of up to 16 mg/kg.
Evidence of histologically or cytologically proven metastatic or locally advanced unresectable endometrial cancer bearing either the S252W or the P243R FGFR2 mutation. --- S252W ---
Description: To assess the response rate of advanced endometrial cancer patients bearing FGFR-specific mutations
Measure: Response rate Time: up to 1 yearDescription: To assess 6-month progression free survival of advanced endometrial cancer patients bearing FGFR-specific mutations
Measure: Progression-free survival Time: 6 monthsDescription: To evaluate the safety and tolerability of FP-1039 in subjects with advanced endometrial cancer
Measure: Safety and tolerability Time: up to 1 yearDescription: To determine pharmacokinetics (PK) plasma concentration at specified times
Measure: Pharmacokinetics of Plasma Time: up to 1 yearTo 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.
Activating mutations are defined as the known FGFR2 hotspots at S252W, P253R, S373C, Y376C, C383R, N550K, N550H, K660E. --- S252W ---
Description: 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.
Measure: Tumor responses (CR + PR) Time: 6 monthsDescription: 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.
Measure: Progression Free survival Time: 6 monthsDescription: Progression Free Survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
Measure: Progression Free Survival Time: 5.5 yearsDescription: Overall survival is define as date from time of initial treatment to date of death from any cause.
Measure: overall survival Time: 5.5 yearsDescription: Frequency and severity as defined by CTCAE v 4.0
Measure: Toxicity of Ponatinib Time: 1 year