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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

the antitumor activity of TKI258, as measured by an 18-week progression free survival rate

Outcome Description:

The 18-week PFS is defined as the percentage of patients who do not have a progression event at week 18

Outcome Time Frame:

up to 18 weeks after the first dose of study drug

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CTKI258A2211

NCT ID:

NCT01379534

Start Date:

November 2011

Completion Date:

January 2015

Related Keywords:

• Solid Tumors and Advanced Endometrial Cancer
• Endometrial Cancer
• Second-line Treatment
• VEGF
• 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
• Endometrial Neoplasms
• Sarcoma, Endometrial Stromal
• Adenoma