SNPMiner Trials by Shray Alag
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SNPMiner Trials (Home Page)
Report for Mutation S252W
Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene
There are 2 clinical trials
Clinical Trials
1 An Open-Label Phase 2 Pilot Study Evaluating the Activity and Safety of FP 1039 in Subjects With Advanced and/or Recurrent Endometrial Cancers With Specific FGFR2 Mutations
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.
NCT01244438 Conditions
- Endometrial Cancers With FGFR2 Mutations
Interventions
- Drug: FP-1039
MeSH:Endometrial Neoplasms
HPO:Endometrial carcinoma
Evidence of histologically or cytologically proven metastatic or locally advanced unresectable endometrial cancer bearing either the S252W or the P243R FGFR2 mutation. --- S252W ---
Primary Outcomes
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 monthsSecondary Outcomes
Description: 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 year2 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
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.
NCT01888562 Conditions
- Endometrial Neoplasms
Interventions
- Drug: Ponatinib
MeSH:Endometrial Neoplasms
HPO:Endometrial carcinoma
Activating mutations are defined as the known FGFR2 hotspots at S252W, P253R, S373C, Y376C, C383R, N550K, N550H, K660E. --- S252W ---
Primary Outcomes
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 monthsSecondary Outcomes
Description: 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