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

Endometrial Cancer Clinical Trial

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

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

• Endometrial Cancer
• Endometrial Neoplasms
• Second-line Treatment
• Solid Tumors and Advanced Endometrial Cancer
• VEGF

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