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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01379534




Registration number
NCT01379534
Ethics application status
Date submitted
6/06/2011
Date registered
23/06/2011
Date last updated
20/05/2015

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2011-000266-35
Secondary ID [2] 0 0
CTKI258A2211
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumors and Advanced Endometrial Cancer 0 0
Endometrial Cancer 0 0
Second-line Treatment 0 0
VEGF 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: TKI258 - 1 treatment arm (single agent TKI258), with patients classified into 2 groups based on their FGFR2 mutation status
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) Rate
Timepoint [1] 0 0
up to 18 weeks
Secondary outcome [1] 0 0
Overall Response Rate (ORR)
Timepoint [1] 0 0
Baseline and every 6 weeks until disease progression, up to 18 weeks
Secondary outcome [2] 0 0
Disease Control Rate (DCR)
Timepoint [2] 0 0
Baseline and every 6 weeks until disease progression, up to 18 weeks
Secondary outcome [3] 0 0
Duration of Response (DR)
Timepoint [3] 0 0
up to 18 weeks
Secondary outcome [4] 0 0
Overall Survival (OS)
Timepoint [4] 0 0
up to 18 weeks
Secondary outcome [5] 0 0
Progression Free Survival (PFS)
Timepoint [5] 0 0
up to 18 weeks
Secondary outcome [6] 0 0
Number of Participants With Adverse Events, Serious Adverse Events and Deaths
Timepoint [6] 0 0
up to 30 days after the last dose of study drug, up to 18 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2014
Sample size
Target
Accrual to date
Final
53
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Nebraska
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Virginia
Country [13] 0 0
United States of America
State/province [13] 0 0
Washington
Country [14] 0 0
Brazil
State/province [14] 0 0
MG
Country [15] 0 0
Brazil
State/province [15] 0 0
RS
Country [16] 0 0
Brazil
State/province [16] 0 0
SP
Country [17] 0 0
Italy
State/province [17] 0 0
GE
Country [18] 0 0
Italy
State/province [18] 0 0
MB
Country [19] 0 0
Italy
State/province [19] 0 0
MI
Country [20] 0 0
Italy
State/province [20] 0 0
PI
Country [21] 0 0
Italy
State/province [21] 0 0
RM
Country [22] 0 0
Italy
State/province [22] 0 0
TO
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Korea
Country [24] 0 0
Korea, Republic of
State/province [24] 0 0
Seoul
Country [25] 0 0
New Zealand
State/province [25] 0 0
Grafton, Auckland
Country [26] 0 0
Spain
State/province [26] 0 0
Andalucia
Country [27] 0 0
Spain
State/province [27] 0 0
Asturias
Country [28] 0 0
Spain
State/province [28] 0 0
Barcelona
Country [29] 0 0
Spain
State/province [29] 0 0
Catalunya
Country [30] 0 0
Spain
State/province [30] 0 0
Madrid
Country [31] 0 0
Spain
State/province [31] 0 0
Murcia
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Glasgow
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Leeds
Country [34] 0 0
United Kingdom
State/province [34] 0 0
London
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01379534
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01379534