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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
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2011-000266-35
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Secondary ID [2]
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CTKI258A2211
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Solid Tumors and Advanced Endometrial Cancer
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Endometrial Cancer
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Second-line Treatment
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VEGF
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Condition category
Condition code
Cancer
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Womb (Uterine or endometrial cancer)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - TKI258
Experimental: TKI258 - 1 treatment arm (single agent TKI258), with patients classified into 2 groups based on their FGFR2 mutation status
Treatment: Drugs: TKI258
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression Free Survival (PFS) Rate
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Assessment method [1]
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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.
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Timepoint [1]
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up to 18 weeks
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Secondary outcome [1]
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Overall Response Rate (ORR)
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Assessment method [1]
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ORR is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR).
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Timepoint [1]
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Baseline and every 6 weeks until disease progression, up to 18 weeks
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Secondary outcome [2]
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Disease Control Rate (DCR)
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Assessment method [2]
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DCR was defined as the percentage of participants with a best overall response of CR or PR or stable disease (SD).
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Timepoint [2]
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Baseline and every 6 weeks until disease progression, up to 18 weeks
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Secondary outcome [3]
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Duration of Response (DR)
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Assessment method [3]
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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.
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Timepoint [3]
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up to 18 weeks
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Secondary outcome [4]
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Overall Survival (OS)
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Assessment method [4]
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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.
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Timepoint [4]
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up to 18 weeks
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Secondary outcome [5]
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Progression Free Survival (PFS)
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Assessment method [5]
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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.
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Timepoint [5]
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up to 18 weeks
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Secondary outcome [6]
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Number of Participants With Adverse Events, Serious Adverse Events and Deaths
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Assessment method [6]
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Adverse event monitoring was conducted throughout the study.
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Timepoint [6]
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up to 30 days after the last dose of study drug, up to 18 weeks
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2014
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Sample size
Target
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Accrual to date
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Final
53
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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United States of America
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Alabama
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United States of America
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California
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Colorado
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United States of America
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Florida
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United States of America
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Indiana
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United States of America
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Iowa
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United States of America
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Massachusetts
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Nebraska
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United States of America
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North Carolina
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Tennessee
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United States of America
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Texas
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Virginia
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Washington
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Brazil
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MG
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Brazil
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RS
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Brazil
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SP
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Italy
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GE
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Italy
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MB
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Italy
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MI
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Italy
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PI
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Italy
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RM
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Italy
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TO
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Korea, Republic of
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Korea
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Korea, Republic of
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Seoul
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New Zealand
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Grafton, Auckland
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Spain
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Andalucia
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Spain
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Asturias
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Spain
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Barcelona
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Spain
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Catalunya
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Spain
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Madrid
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Spain
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Murcia
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United Kingdom
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Glasgow
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United Kingdom
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Leeds
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United Kingdom
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London
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United Kingdom
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Nottingham
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01379534
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01379534
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