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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01379534
Other study ID # CTKI258A2211
Secondary ID 2011-000266-35
Status Completed
Phase Phase 2
First received June 6, 2011
Last updated May 2, 2015
Start date November 2011
Est. completion date March 2014

Study information

Verified date May 2015
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCanada: Health CanadaBelgium: Federal Agency for Medicines and Health Products, FAMHPGermany: Federal Institutes for Drugs and Medical Devices (BfArM)Netherlands: Medicines Evaluation BoardSingapore: Health Science AuthorityItaly: Italian Medicines Agency (AIFA)
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
TKI258


Locations

Country Name City State
Brazil Novartis Investigative Site Belo Horizonte MG
Brazil Novartis Investigative Site Porto Alegre RS
Brazil Novartis Investigative Site Ribeirao Preto SP
Italy Novartis Investigative Site Candiolo TO
Italy Novartis Investigative Site Genova GE
Italy Novartis Investigative Site Milano MI
Italy Novartis Investigative Site Milano MI
Italy Novartis Investigative Site Monza MB
Italy Novartis Investigative Site Pisa PI
Italy Novartis Investigative Site Roma RM
Korea, Republic of Novartis Investigative Site Seoul Korea
Korea, Republic of Novartis Investigative Site Seoul
New Zealand Novartis Investigative Site Grafton, Auckland
Spain Novartis Investigative Site Barcelona Catalunya
Spain Novartis Investigative Site Cordoba Andalucia
Spain Novartis Investigative Site Majadahonda Madrid
Spain Novartis Investigative Site Málaga Andalucia
Spain Novartis Investigative Site Murcia
Spain Novartis Investigative Site Oviedo Asturias
Spain Novartis Investigative Site Sabadell Barcelona
United Kingdom Novartis Investigative Site Glasgow
United Kingdom Novartis Investigative Site Leeds
United Kingdom Novartis Investigative Site London
United Kingdom Novartis Investigative Site Nottingham
United States Virginia Oncology Associates VOA - Lake Wright *see Various Departments* Virginia
United States Hope A Woman's Cancer Center Asheville North Carolina
United States Texas Oncology, P.A. Austin Bedford Texas
United States Texas Oncology, P.A. Tex Onc (3) Bedford Texas
United States Dana Farber Cancer Institute SC Boston Massachusetts
United States Community Oncology Research Network Chattanooga Tennessee
United States Duke University Medical Center Duke3 Durham North Carolina
United States Texas Oncology, P.A. SC Fort Worth Texas
United States St. Jude Heritage Medical Group St Jude Fullerton California
United States Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer Greenwood Village Colorado
United States Indiana University Health Goshen Center for Cancer IU Simon Cancer Indianapolis Indiana
United States University of Iowa Hospitals & Clinics SC Iowa City Iowa
United States Southeast Nebraska Oncology Cancer Center Lincoln Nebraska
United States Cedars Sinai Medical Center TKI258A2211 (SC) Los Angeles California
United States University of California at Los Angeles UCLA 3 Los Angeles California
United States USC/Kenneth Norris Comprehensive Cancer Center USC 2 Los Angeles California
United States The West Clinic SC Memphis Tennessee
United States University of South Alabama / Mitchell Cancer Institute Univ South Alabama Mobile Alabama
United States Florida Hospital Cancer Institute FL Hosp Orlando Florida
United States South Texas Oncology and Hematology, PA South Tex Onc San Antonio Texas
United States Cancer Care Northwest SC Spokane Washington

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Brazil,  Italy,  Korea, Republic of,  New Zealand,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. up to 18 weeks No
Secondary 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). Baseline and every 6 weeks until disease progression, up to 18 weeks No
Secondary 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). Baseline and every 6 weeks until disease progression, up to 18 weeks No
Secondary 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. up to 18 weeks No
Secondary 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. up to 18 weeks No
Secondary 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. up to 18 weeks No
Secondary Number of Participants With Adverse Events, Serious Adverse Events and Deaths Adverse event monitoring was conducted throughout the study. up to 30 days after the last dose of study drug, up to 18 weeks Yes
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