NCT01379534

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Solid Tumors and Advanced Endometrial Cancer
• Endometrial Cancer
• Second-line Treatment
• VEGF

Interventions

Type	Name	Description
DRUG	TKI258

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2011-06-23
• Last updated: 2015-05-20
• Results posted: 2015-03-31

Locations

45 sites across 7 countries: United States, Brazil, Italy, New Zealand, South Korea, Spain, United Kingdom