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

May 2, 2015 updated by: Novartis Pharmaceuticals

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • MG
      • Belo Horizonte, MG, Brazil, 30150-270
        • Novartis Investigative Site
    • RS
      • Porto Alegre, RS, Brazil, 90610-000
        • Novartis Investigative Site
    • SP
      • Ribeirao Preto, SP, Brazil, 14048-900
        • Novartis Investigative Site
  • Italy
    • GE
      • Genova, GE, Italy, 16132
        • Novartis Investigative Site
    • MB
      • Monza, MB, Italy, 20900
        • Novartis Investigative Site
    • MI
      • Milano, MI, Italy, 20133
        • Novartis Investigative Site
      • Milano, MI, Italy, 20141
        • Novartis Investigative Site
    • PI
      • Pisa, PI, Italy, 56126
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italy, 00168
        • Novartis Investigative Site
    • TO
      • Candiolo, TO, Italy, 10060
        • Novartis Investigative Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 738-736
        • Novartis Investigative Site
    • Korea
      • Seoul, Korea, Korea, Republic of, 135-710
        • Novartis Investigative Site
  • New Zealand
      • Grafton, Auckland, New Zealand
        • Novartis Investigative Site
  • Spain
      • Murcia, Spain, 30008
        • Novartis Investigative Site
    • Andalucia
      • Cordoba, Andalucia, Spain, 14004
        • Novartis Investigative Site
      • Málaga, Andalucia, Spain, 29010
        • Novartis Investigative Site
    • Asturias
      • Oviedo, Asturias, Spain, 33006
        • Novartis Investigative Site
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Novartis Investigative Site
    • Catalunya
      • Barcelona, Catalunya, Spain, 08035
        • Novartis Investigative Site
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Novartis Investigative Site
  • United Kingdom
      • Glasgow, United Kingdom, G12 0YN
        • Novartis Investigative Site
      • Leeds, United Kingdom, LS9 7TF
        • Novartis Investigative Site
      • London, United Kingdom, NW1 2BU
        • Novartis Investigative Site
      • Nottingham, United Kingdom, NG5 1PB
        • Novartis Investigative Site
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36688
        • University of South Alabama / Mitchell Cancer Institute Univ South Alabama
    • California
      • Fullerton, California, United States, 92835
        • St. Jude Heritage Medical Group St Jude
      • Los Angeles, California, United States, 90033
        • USC/Kenneth Norris Comprehensive Cancer Center USC 2
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center TKI258A2211 (SC)
      • Los Angeles, California, United States, 90095
        • University of California at Los Angeles UCLA 3
    • Colorado
      • Greenwood Village, Colorado, United States
        • Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer
    • Florida
      • Orlando, Florida, United States, 32804
        • Florida Hospital Cancer Institute FL Hosp
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health Goshen Center for Cancer IU Simon Cancer
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals & Clinics SC
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute SC
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Southeast Nebraska Oncology Cancer Center
    • North Carolina
      • Asheville, North Carolina, United States, 28806
        • Hope A Woman's Cancer Center
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center Duke3
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Community Oncology Research Network
      • Memphis, Tennessee, United States, 38120
        • The West Clinic SC
    • Texas
      • Bedford, Texas, United States, 76022
        • Texas Oncology, P.A. Austin
      • Bedford, Texas, United States, 76022
        • Texas Oncology, P.A. Tex Onc (3)
      • Fort Worth, Texas, United States, 76104
        • Texas Oncology, P.A. SC
      • San Antonio, Texas, United States, 78258
        • South Texas Oncology and Hematology, PA South Tex Onc
    • Virginia
      • *see Various Departments*, Virginia, United States
        • Virginia Oncology Associates VOA - Lake Wright
    • Washington
      • Spokane, Washington, United States, 99202
        • Cancer Care Northwest SC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TKI258
1 treatment arm (single agent TKI258), with patients classified into 2 groups based on their FGFR2 mutation status
Drug: TKI258
Other Names:
  • dovitinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS) Rate
Time Frame: 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.
up to 18 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: 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).
Baseline and every 6 weeks until disease progression, up to 18 weeks
Disease Control Rate (DCR)
Time Frame: 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).
Baseline and every 6 weeks until disease progression, up to 18 weeks
Duration of Response (DR)
Time Frame: 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.
up to 18 weeks
Overall Survival (OS)
Time Frame: 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.
up to 18 weeks
Progression Free Survival (PFS)
Time Frame: 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.
up to 18 weeks
Number of Participants With Adverse Events, Serious Adverse Events and Deaths
Time Frame: up to 30 days after the last dose of study drug, up to 18 weeks
Adverse event monitoring was conducted throughout the study.
up to 30 days after the last dose of study drug, up to 18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

June 6, 2011

First Submitted That Met QC Criteria

June 22, 2011

First Posted (Estimate)

June 23, 2011

Study Record Updates

Last Update Posted (Estimate)

May 20, 2015

Last Update Submitted That Met QC Criteria

May 2, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTKI258A2211
  • 2011-000266-35 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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