A Phase II Study to Evaluate the Efficacy of TKI258 for the Treatment of Patients With FGFR2 Mutated or Wild-type Advanced and/or Metastatic Endometrial Cancer

Study Overview
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Brief Summary
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This is a prospective, multi-center, open-label, single-arm, non-randomized, Phase II study to evaluate the efficacy and safety of TKI258 as second-line therapy in patients with either FGFR2 mutated or wild-type advanced and/or metastatic endometrial cancer.

Official Title
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A Phase II, Open-label, Single-arm, Non-randomized, Multi-center Study to Evaluate the Efficacy of Oral TKI258 as Second-line Therapy in Patients With Either FGFR2 Mutated or Wild-type Advanced and/or Metastatic Endometrial Cancer

Conditions
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Solid Tumors and Advanced Endometrial Cancer, Endometrial Cancer, Second-line Treatment, VEGF

Intervention / Treatment
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* Drug: TKI258


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with histologically confirmed diagnosis of advanced and/or metastatic endometrial cancer with available tissue specimen (either archival tissue or fixed fresh biopsy) Female patients ≥ 18 years old Documented radiologically confirmed progression of disease after prior first-line treatment evidence of progressive disease ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2 At least one measurable lesion as per RECIST Exclusion Criteria: Previous treatment with an FGFR inhibitor More than one line of treatment for advanced or metastatic disease Patients with uterine sarcomas, adenosarcoma, and malignant Mullerian tumors Patients with isolated recurrences (vaginal, pelvic, or para-aortic) potentially curative with radiation therapy or surgery Known central nervous system (CNS) metastases Malignancy within 3 years of study enrollment Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TKI258<br>1 treatment arm (single agent TKI258), with patients classified into 2 groups based on their FGFR2 mutation status | Drug: TKI258<br> <br> * Other names: dovitinib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) Rate | The 18-week PFS was defined as the percentage of participants who did not have a progression event at week 18. Participants who progressed, died, had response assessment of unknown (UNK) or discontinued before 18 weeks of observation without progression were counted as failure. Progressive disease was assessed as per investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. | up to 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR) | ORR is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR). | Baseline and every 6 weeks until disease progression, up to 18 weeks | 
| Disease Control Rate (DCR) | DCR was defined as the percentage of participants with a best overall response of CR or PR or stable disease (SD). | Baseline and every 6 weeks until disease progression, up to 18 weeks | 
| Duration of Response (DR) | Duration of response was defined for participants with a CR or PR as the time from the date of the first documented response (CR or PR) to the date of the first documented progression or death due to disease. If a participants did not have a progression event, duration of response was censored at the date of the last adequate tumor assessment before the data analysis cut-off date or the antineoplastic therapy start date or the death date. | up to 18 weeks | 
| Overall Survival (OS) | OS was defined as the time from date of treatment to the date of death from any cause. If a participant was not known to have died at the date of analysis cut-off, the OS was censored at the last date of contact. | up to 18 weeks | 
| Progression Free Survival (PFS) | PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. If a participant did not have an event, PFS was censored at the date of last adequate response assessment before the data analysis cut-off date or the start date of new antineoplastic therapy after study drug discontinuation. | up to 18 weeks | 
| Number of Participants With Adverse Events, Serious Adverse Events and Deaths | Adverse event monitoring was conducted throughout the study. | up to 30 days after the last dose of study drug, up to 18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Solid tumors,, advanced endometrial cancer,, Endometrial Cancer,, Second-line treatment,, VEGF,, Neoplasms,, Endometrial Neoplasms,, Uterine Neoplasms,, Female Genital Neoplasms,, Cancer,, Carcinoma,, Uterine Diseases,, Female Genital Diseases,, Tumors,, Oral Administration,, Capsules,, Tablets,, CHIR258,, CHIR-258,, CHIR 258,, TKI258,, TKI-258,, TKI 258