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 Pharmaceuticals53 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (45)

University of South Alabama / Mitchell Cancer Institute Univ South Alabama

Mobile, Alabama, United States

St. Jude Heritage Medical Group St Jude

Fullerton, California, United States

USC/Kenneth Norris Comprehensive Cancer Center USC 2

Los Angeles, California, United States

Cedars Sinai Medical Center TKI258A2211 (SC)

Los Angeles, California, United States

University of California at Los Angeles UCLA 3

Los Angeles, California, United States

Outcomes

Primary Outcomes

Progression Free Survival (PFS) Rate

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.

Time frame: up to 18 weeks

Secondary Outcomes

Overall Response Rate (ORR)

ORR is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR).

Time frame: Baseline and every 6 weeks until disease progression, up to 18 weeks

Disease Control Rate (DCR)

DCR was defined as the percentage of participants with a best overall response of CR or PR or stable disease (SD).

Time frame: Baseline and every 6 weeks until disease progression, up to 18 weeks

Duration of Response (DR)

Duration of response was defined for participants with a CR or PR as the time from the date of the first documented response (CR or PR) to the date of the first documented progression or death due to disease. If a participants did not have a progression event, duration of response was censored at the date of the last adequate tumor assessment before the data analysis cut-off date or the antineoplastic therapy start date or the death date.

Time frame: up to 18 weeks

Overall Survival (OS)

OS was defined as the time from date of treatment to the date of death from any cause. If a participant was not known to have died at the date of analysis cut-off, the OS was censored at the last date of contact.

Time frame: up to 18 weeks

Progression Free Survival (PFS)

PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. If a participant did not have an event, PFS was censored at the date of last adequate response assessment before the data analysis cut-off date or the start date of new antineoplastic therapy after study drug discontinuation.

Time frame: up to 18 weeks

Number of Participants With Adverse Events, Serious Adverse Events and Deaths

Adverse event monitoring was conducted throughout the study.

Time frame: up to 30 days after the last dose of study drug, up to 18 weeks