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

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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