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

Novartis

Status and phase

Completed

Phase 2

Conditions

Endometrial Cancer

VEGF

Solid Tumors and Advanced Endometrial Cancer

Second-line Treatment

Treatments

Drug: TKI258

Study type

Interventional

Funder types

Industry

Identifiers

NCT01379534

CTKI258A2211

2011-000266-35 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

53 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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