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
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.
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 |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States, Brazil, Italy, Korea, Republic of, New Zealand, Spain, United Kingdom,
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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