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

Novartis Pharmaceuticals22 sites in 2 countries53 target enrollmentNovember 2011

ConditionsSolid Tumors and Advanced Endometrial Cancer Endometrial Cancer Second-line Treatment VEGF

InterventionsTKI258

DrugsTKI258

Overview

Phase: Phase 2
Intervention: TKI258
Conditions: Solid Tumors and Advanced Endometrial Cancer
Sponsor: Novartis Pharmaceuticals
Enrollment: 53
Locations: 22
Primary Endpoint: Progression Free Survival (PFS) Rate
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 2011

End Date

March 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

TKI258

1 treatment arm (single agent TKI258), with patients classified into 2 groups based on their FGFR2 mutation status

Intervention: TKI258

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Disease Control Rate (DCR)(Baseline and every 6 weeks until disease progression, up to 18 weeks)
Number of Participants With Adverse Events, Serious Adverse Events and Deaths(up to 30 days after the last dose of study drug, up to 18 weeks)
Progression Free Survival (PFS)(up to 18 weeks)
Overall Survival (OS)(up to 18 weeks)
Overall Response Rate (ORR)(Baseline and every 6 weeks until disease progression, up to 18 weeks)
Duration of Response (DR)(up to 18 weeks)