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

Phase 2

Completed

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

Interventions: Drug: TKI258

Registration Number: NCT01379534

Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 53

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS) Rate	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 Outcome Measures

Name	Time	Method
Disease Control Rate (DCR)	Baseline and every 6 weeks until disease progression, up to 18 weeks	DCR was defined as the percentage of participants with a best overall response of CR or PR or stable disease (SD).
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	Adverse event monitoring was conducted throughout the study.
Progression Free Survival (PFS)	up to 18 weeks	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.
Overall Survival (OS)	up to 18 weeks	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.
Overall Response Rate (ORR)	Baseline and every 6 weeks until disease progression, up to 18 weeks	ORR is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR).
Duration of Response (DR)	up to 18 weeks	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.

Trial Locations

Locations (22): University of South Alabama / Mitchell Cancer Institute Univ South Alabama
🇺🇸
Mobile, Alabama, United States
St. Jude Heritage Medical Group St Jude
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Fullerton, California, United States
USC/Kenneth Norris Comprehensive Cancer Center USC 2
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Los Angeles, California, United States
Cedars Sinai Medical Center TKI258A2211 (SC)
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Los Angeles, California, United States
University of California at Los Angeles UCLA 3
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Los Angeles, California, United States
Indiana University Health Goshen Center for Cancer IU Simon Cancer
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Indianapolis, Indiana, United States
Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer
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Greenwood Village, Colorado, United States
University of Iowa Hospitals & Clinics SC
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Iowa City, Iowa, United States
Dana Farber Cancer Institute SC
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Boston, Massachusetts, United States
Southeast Nebraska Oncology Cancer Center
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Lincoln, Nebraska, United States
Hope A Woman's Cancer Center
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Asheville, North Carolina, United States
Community Oncology Research Network
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Chattanooga, Tennessee, United States
The West Clinic SC
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Memphis, Tennessee, United States
Texas Oncology, P.A. Austin
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Bedford, Texas, United States
Texas Oncology, P.A. Tex Onc (3)
🇺🇸
Bedford, Texas, United States
Texas Oncology, P.A. SC
🇺🇸
Fort Worth, Texas, United States
Virginia Oncology Associates VOA - Lake Wright
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*see Various Departments*, Virginia, United States
Novartis Investigative Site
🇬🇧
Nottingham, United Kingdom
Cancer Care Northwest SC
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Spokane, Washington, United States
Duke University Medical Center Duke3
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Durham, North Carolina, United States
South Texas Oncology and Hematology, PA South Tex Onc
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San Antonio, Texas, United States
Florida Hospital Cancer Institute FL Hosp
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Orlando, Florida, United States