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
18 Years
N/A
Open (Enrolling)
Female
Solid Tumors and Advanced Endometrial Cancer, Endometrial Cancer, Second-line Treatment, VEGF
Female
Solid Tumors and Advanced Endometrial Cancer, Endometrial Cancer, Second-line Treatment, VEGF
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 Corporation | Santa Maria, California 93454 |
| US Oncology Central Monitoring | Dallas, Texas 75246 |
| Virginia Oncology Associates VOA - Lake Wright | *see Various Departments*, Virginia |
| Dana Farber Cancer Institute SC | Boston, Massachusetts 02115 |
| Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer | Greenwood Village, Colorado |
| University of South Alabama / Mitchell Cancer Institute Univ South Alabama | Mobile, Alabama 36688 |
| St. Jude Heritage Medical Group St Jude | Fullerton, California 92835 |
| USC/Kenneth Norris Comprehensive Cancer Center USC 2 | Los Angeles, California 90033 |
| Cedars Sinai Medical Center TKI258A2211 (SC) | Los Angeles, California 90048 |
| Yale University School of Medicine Yale SC | New Haven, Connecticut 06520 |
| Florida Hospital Cancer Institute FL Hosp | Orlando, Florida 32806 |
| Memorial Cancer Institute Memorial Cancer | Pembroke Pines, Florida 33028 |
| Queen's Medical Center Queen | Honolulu, Hawaii 96817 |
| Northwestern University Northwestern | Chicago, Illinois 60611 |
| Indiana University Health Goshen Center for Cancer IU Simon Cancer | Indianapolis, Indiana 46202 |
| University of Iowa Hospitals & Clinics SC | Iowa City, Iowa 52242 |
| University of Kansas Cancer Center Univ KS | Kansas City, Kansas 66160 |
| Southeast Nebraska Oncology Cancer Center | Lincoln, Nebraska 68510 |
| Morristown Memorial Hospital SC | Morristown, New Jersey 07962 |
| Hope A Woman's Cancer Center | Asheville, North Carolina 28806 |
| Duke University Medical Center Duke3 | Durham, North Carolina 27710 |
| Community Oncology Research Network | Chattanooga, Tennessee 37403 |
| The West Clinic SC | Memphis, Tennessee 38120 |
| Vanderbilt University Medical Center SC-2 | Nashville, Tennessee 37232 |
| Texas Oncology, P.A. Austin | Bedford, Texas 76022 |
| Texas Oncology, P.A. Tex Onc (3) | Bedford, Texas 76022 |
| South Texas Oncology and Hematology, PA South Tex Onc | San Antonio, Texas 78258 |
| University of Utah / Huntsman Cancer Institute HCI | Salt Lake City, Utah 84103 |
| Cancer Care Northwest SC | Spokane, Washington 99202 |
| University of California at Los Angeles UCLA 3 | Los Angeles, California 90095 |
| University of California at Los Angeles TORI Central Monitring Site | Los Angeles, California 90095 |
| Massachusetts General Hospital Univ of Mass. Medical Ctr. | Boston, Massachusetts 02114 |
| Cancer Centers of the Carolinas SC-1 | Greenville, South Carolina 29605 |
| Texas Oncology, P.A. SC | Fort Worth, Texas 76104 |
