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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

Primary Purpose

Solid Tumors and Advanced Endometrial Cancer, Endometrial Cancer, Second-line Treatment

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TKI258
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumors and Advanced Endometrial Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of South Alabama / Mitchell Cancer Institute Univ South Alabama
  • St. Jude Heritage Medical Group St Jude
  • USC/Kenneth Norris Comprehensive Cancer Center USC 2
  • Cedars Sinai Medical Center TKI258A2211 (SC)
  • University of California at Los Angeles UCLA 3
  • Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer
  • Florida Hospital Cancer Institute FL Hosp
  • Indiana University Health Goshen Center for Cancer IU Simon Cancer
  • University of Iowa Hospitals & Clinics SC
  • Dana Farber Cancer Institute SC
  • Southeast Nebraska Oncology Cancer Center
  • Hope A Woman's Cancer Center
  • Duke University Medical Center Duke3
  • Community Oncology Research Network
  • The West Clinic SC
  • Texas Oncology, P.A. Austin
  • Texas Oncology, P.A. Tex Onc (3)
  • Texas Oncology, P.A. SC
  • South Texas Oncology and Hematology, PA South Tex Onc
  • Virginia Oncology Associates VOA - Lake Wright
  • Cancer Care Northwest SC
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TKI258

Arm Description

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

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS) Rate
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

Overall Response Rate (ORR)
ORR is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR).
Disease Control Rate (DCR)
DCR was defined as the percentage of participants with a best overall response of CR or PR or stable disease (SD).
Duration of Response (DR)
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.
Overall Survival (OS)
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.
Progression Free Survival (PFS)
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.
Number of Participants With Adverse Events, Serious Adverse Events and Deaths
Adverse event monitoring was conducted throughout the study.

Full Information

First Posted
June 6, 2011
Last Updated
May 2, 2015
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01379534
Brief 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
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

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TKI258
Arm Type
Experimental
Arm Description
1 treatment arm (single agent TKI258), with patients classified into 2 groups based on their FGFR2 mutation status
Intervention Type
Drug
Intervention Name(s)
TKI258
Other Intervention Name(s)
dovitinib
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) Rate
Description
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.
Time Frame
up to 18 weeks
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
ORR is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR).
Time Frame
Baseline and every 6 weeks until disease progression, up to 18 weeks
Title
Disease Control Rate (DCR)
Description
DCR was defined as the percentage of participants with a best overall response of CR or PR or stable disease (SD).
Time Frame
Baseline and every 6 weeks until disease progression, up to 18 weeks
Title
Duration of Response (DR)
Description
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.
Time Frame
up to 18 weeks
Title
Overall Survival (OS)
Description
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.
Time Frame
up to 18 weeks
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
up to 18 weeks
Title
Number of Participants With Adverse Events, Serious Adverse Events and Deaths
Description
Adverse event monitoring was conducted throughout the study.
Time Frame
up to 30 days after the last dose of study drug, up to 18 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
University of South Alabama / Mitchell Cancer Institute Univ South Alabama
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36688
Country
United States
Facility Name
St. Jude Heritage Medical Group St Jude
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
USC/Kenneth Norris Comprehensive Cancer Center USC 2
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cedars Sinai Medical Center TKI258A2211 (SC)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of California at Los Angeles UCLA 3
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer
City
Greenwood Village
State/Province
Colorado
Country
United States
Facility Name
Florida Hospital Cancer Institute FL Hosp
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Indiana University Health Goshen Center for Cancer IU Simon Cancer
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Iowa Hospitals & Clinics SC
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Dana Farber Cancer Institute SC
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Southeast Nebraska Oncology Cancer Center
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Hope A Woman's Cancer Center
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28806
Country
United States
Facility Name
Duke University Medical Center Duke3
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Community Oncology Research Network
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
The West Clinic SC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Texas Oncology, P.A. Austin
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
Texas Oncology, P.A. Tex Onc (3)
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
Texas Oncology, P.A. SC
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
South Texas Oncology and Hematology, PA South Tex Onc
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Virginia Oncology Associates VOA - Lake Wright
City
*see Various Departments*
State/Province
Virginia
Country
United States
Facility Name
Cancer Care Northwest SC
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Novartis Investigative Site
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30150-270
Country
Brazil
Facility Name
Novartis Investigative Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Novartis Investigative Site
City
Ribeirao Preto
State/Province
SP
ZIP/Postal Code
14048-900
Country
Brazil
Facility Name
Novartis Investigative Site
City
Genova
State/Province
GE
ZIP/Postal Code
16132
Country
Italy
Facility Name
Novartis Investigative Site
City
Monza
State/Province
MB
ZIP/Postal Code
20900
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20133
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20141
Country
Italy
Facility Name
Novartis Investigative Site
City
Pisa
State/Province
PI
ZIP/Postal Code
56126
Country
Italy
Facility Name
Novartis Investigative Site
City
Roma
State/Province
RM
ZIP/Postal Code
00168
Country
Italy
Facility Name
Novartis Investigative Site
City
Candiolo
State/Province
TO
ZIP/Postal Code
10060
Country
Italy
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
738-736
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Grafton, Auckland
Country
New Zealand
Facility Name
Novartis Investigative Site
City
Cordoba
State/Province
Andalucia
ZIP/Postal Code
14004
Country
Spain
Facility Name
Novartis Investigative Site
City
Málaga
State/Province
Andalucia
ZIP/Postal Code
29010
Country
Spain
Facility Name
Novartis Investigative Site
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33006
Country
Spain
Facility Name
Novartis Investigative Site
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08035
Country
Spain
Facility Name
Novartis Investigative Site
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Novartis Investigative Site
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Facility Name
Novartis Investigative Site
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25981814
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.
Results Reference
derived

Learn more about this trial

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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