Clinical trial NCT01379534: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Solid Tumors and Advanced Endometrial Cancer
Endometrial Cancer
Second-line Treatment
VEGF
Keywords: Solid tumors,
advanced endometrial cancer,
Endometrial Cancer,
Second-line treatment,
VEGF,
Neoplasms,
Endometrial Neoplasms,
Uterine Neoplasms,
Female Genital Neoplasms,
Cancer,
Carcinoma,
Uterine Diseases,
Female Genital Diseases,
Tumors,
Oral Administration,
Capsules,
Tablets,
CHIR258,
CHIR-258,
CHIR 258,
TKI258,
TKI-258,
TKI 258
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-06-23
Enrollment: 53
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Progression Free Survival (PFS) Rate
timeFrame: up to 18 weeks
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Baseline and every 6 weeks until disease progression, up to 18 weeks
measure: Disease Control Rate (DCR)
timeFrame: Baseline and every 6 weeks until disease progression, up to 18 weeks
measure: Duration of Response (DR)
timeFrame: up to 18 weeks
measure: Overall Survival (OS)
timeFrame: up to 18 weeks
measure: Progression Free Survival (PFS)
timeFrame: up to 18 weeks
measure: Number of Participants With Adverse Events, Serious Adverse Events and Deaths
timeFrame: up to 30 days after the last dose of study drug, up to 18 weeks
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama / Mitchell Cancer Institute Univ South Alabama
state: Alabama
city: Fullerton
country: United States
facility: St. Jude Heritage Medical Group St Jude
state: California
city: Los Angeles
country: United States
facility: USC/Kenneth Norris Comprehensive Cancer Center USC 2
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center TKI258A2211 (SC)
state: California
city: Los Angeles
country: United States
facility: University of California at Los Angeles UCLA 3
state: California
city: Greenwood Village
country: United States
facility: Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer
state: Colorado
city: Orlando
country: United States
facility: Florida Hospital Cancer Institute FL Hosp
state: Florida
city: Indianapolis
country: United States
facility: Indiana University Health Goshen Center for Cancer IU Simon Cancer
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics SC
state: Iowa
city: Boston
country: United States
facility: Dana Farber Cancer Institute SC
state: Massachusetts
city: Lincoln
country: United States
facility: Southeast Nebraska Oncology Cancer Center
state: Nebraska
city: Asheville
country: United States
facility: Hope A Woman's Cancer Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center Duke3
state: North Carolina
city: Chattanooga
country: United States
facility: Community Oncology Research Network
state: Tennessee
city: Memphis
country: United States
facility: The West Clinic SC
state: Tennessee
city: Bedford
country: United States
facility: Texas Oncology, P.A. Austin
state: Texas
city: Bedford
country: United States
facility: Texas Oncology, P.A. Tex Onc (3)
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology, P.A. SC
state: Texas
city: San Antonio
country: United States
facility: South Texas Oncology and Hematology, PA South Tex Onc
state: Texas
city: *see Various Departments*
country: United States
facility: Virginia Oncology Associates VOA - Lake Wright
state: Virginia
city: Spokane
country: United States
facility: Cancer Care Northwest SC
state: Washington
city: Belo Horizonte
country: Brazil
facility: Novartis Investigative Site
state: MG
city: Porto Alegre
country: Brazil
facility: Novartis Investigative Site
state: RS
city: Ribeirao Preto
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Genova
country: Italy
facility: Novartis Investigative Site
state: GE
city: Monza
country: Italy
facility: Novartis Investigative Site
state: MB
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Pisa
country: Italy
facility: Novartis Investigative Site
state: PI
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Candiolo
country: Italy
facility: Novartis Investigative Site
state: TO
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Grafton, Auckland
country: New Zealand
facility: Novartis Investigative Site
city: Cordoba
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Málaga
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Oviedo
country: Spain
facility: Novartis Investigative Site
state: Asturias
city: Sabadell
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Majadahonda
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: Murcia
country: Spain
facility: Novartis Investigative Site
city: Glasgow
country: United Kingdom
facility: Novartis Investigative Site
city: Leeds
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Nottingham
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Konecny GE, Finkler N, Garcia AA, Lorusso D, Lee PS, Rocconi RP, Fong PC, Squires M, Mishra K, Upalawanna A, Wang Y, Kristeleit R. Second-line dovitinib (TKI258) in patients with FGFR2-mutated or FGFR2-non-mutated advanced or metastatic endometrial cancer: a non-randomised, open-label, two-group, two-stage, phase 2 study. Lancet Oncol. 2015 Jun;16(6):686-94. doi: 10.1016/S1470-2045(15)70159-2. Epub 2015 May 13.