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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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Solid Tumors and Advanced Endometrial Cancer, Endometrial Cancer, Second-line Treatment, VEGF

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

the antitumor activity of TKI258, as measured by an 18-week progression free survival rate

Outcome Description:

The 18-week PFS is defined as the percentage of patients who do not have a progression event at week 18

Outcome Time Frame:

up to 18 weeks after the first dose of study drug

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CTKI258A2211

NCT ID:

NCT01379534

Start Date:

November 2011

Completion Date:

January 2015

Related Keywords:

  • Solid Tumors and Advanced Endometrial Cancer
  • Endometrial Cancer
  • Second-line Treatment
  • VEGF
  • 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
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

Name

Location

Central Coast Medical Oncology CorporationSanta Maria, California  93454
US Oncology Central MonitoringDallas, Texas  75246
Virginia Oncology Associates VOA - Lake Wright*see Various Departments*, Virginia  
Dana Farber Cancer Institute SCBoston, Massachusetts  02115
Rocky Mountain Cancer Centers Dept. of Rocky Mountain CancerGreenwood Village, Colorado  
University of South Alabama / Mitchell Cancer Institute Univ South AlabamaMobile, Alabama  36688
St. Jude Heritage Medical Group St JudeFullerton, California  92835
USC/Kenneth Norris Comprehensive Cancer Center USC 2Los Angeles, California  90033
Cedars Sinai Medical Center TKI258A2211 (SC)Los Angeles, California  90048
Yale University School of Medicine Yale SCNew Haven, Connecticut  06520
Florida Hospital Cancer Institute FL HospOrlando, Florida  32806
Memorial Cancer Institute Memorial CancerPembroke Pines, Florida  33028
Queen's Medical Center QueenHonolulu, Hawaii  96817
Northwestern University NorthwesternChicago, Illinois  60611
Indiana University Health Goshen Center for Cancer IU Simon CancerIndianapolis, Indiana  46202
University of Iowa Hospitals & Clinics SCIowa City, Iowa  52242
University of Kansas Cancer Center Univ KSKansas City, Kansas  66160
Southeast Nebraska Oncology Cancer CenterLincoln, Nebraska  68510
Morristown Memorial Hospital SCMorristown, New Jersey  07962
Hope A Woman's Cancer CenterAsheville, North Carolina  28806
Duke University Medical Center Duke3Durham, North Carolina  27710
Community Oncology Research NetworkChattanooga, Tennessee  37403
The West Clinic SCMemphis, Tennessee  38120
Vanderbilt University Medical Center SC-2Nashville, Tennessee  37232
Texas Oncology, P.A. AustinBedford, Texas  76022
Texas Oncology, P.A. Tex Onc (3)Bedford, Texas  76022
South Texas Oncology and Hematology, PA South Tex OncSan Antonio, Texas  78258
University of Utah / Huntsman Cancer Institute HCISalt Lake City, Utah  84103
Cancer Care Northwest SCSpokane, Washington  99202
University of California at Los Angeles UCLA 3Los Angeles, California  90095
University of California at Los Angeles TORI Central Monitring SiteLos Angeles, California  90095
Massachusetts General Hospital Univ of Mass. Medical Ctr.Boston, Massachusetts  02114
Cancer Centers of the Carolinas SC-1Greenville, South Carolina  29605
Texas Oncology, P.A. SCFort Worth, Texas  76104