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
|ClinicalTrials.gov Identifier: NCT01379534|
Recruitment Status : Completed
First Posted : June 23, 2011
Results First Posted : March 31, 2015
Last Update Posted : May 20, 2015
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors and Advanced Endometrial Cancer Endometrial Cancer Second-line Treatment VEGF||Drug: TKI258||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||November 2011|
|Primary Completion Date :||March 2014|
|Study Completion Date :||March 2014|
1 treatment arm (single agent TKI258), with patients classified into 2 groups based on their FGFR2 mutation status
Other Name: dovitinib
- Progression Free Survival (PFS) Rate [ Time Frame: up to 18 weeks ]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.
- Overall Response Rate (ORR) [ Time Frame: Baseline and every 6 weeks until disease progression, up to 18 weeks ]ORR is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR).
- Disease Control Rate (DCR) [ Time Frame: Baseline and every 6 weeks until disease progression, up to 18 weeks ]DCR was defined as the percentage of participants with a best overall response of CR or PR or stable disease (SD).
- Duration of Response (DR) [ Time Frame: up to 18 weeks ]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.
- Overall Survival (OS) [ Time Frame: up to 18 weeks ]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.
- Progression Free Survival (PFS) [ Time Frame: up to 18 weeks ]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.
- Number of Participants With Adverse Events, Serious Adverse Events and Deaths [ Time Frame: up to 30 days after the last dose of study drug, up to 18 weeks ]Adverse event monitoring was conducted throughout the study.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01379534
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|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|