Cabozantinib-S-Malate in Treating Patients With Recurrent or Metastatic Endometrial Cancer
|Endometrial Adenosquamous Carcinoma Endometrial Clear Cell Adenocarcinoma Endometrial Mixed Adenocarcinoma Endometrial Serous Adenocarcinoma Metastatic Endometrioid Adenocarcinoma Recurrent Uterine Corpus Carcinoma Stage IV Uterine Corpus Cancer Stage IVA Uterine Corpus Cancer Stage IVB Uterine Corpus Cancer Uterine Corpus Carcinosarcoma||Drug: Cabozantinib S-malate Other: Laboratory Biomarker Analysis Other: Pharmacological Study||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of XL184 (Cabozantinib) in Recurrent or Metastatic Endometrial Cancer|
- Progression-free survival [ Time Frame: Time from start of treatment to time of progression or death, assessed at 12 weeks ]Defined as the percentage of patients progression free 12 weeks from starting treatment.
- Response rate [ Time Frame: Up to 12 weeks post-treatment ]Assessed using Response Evaluation Criteria in Solid Tumors version 1.1.
- Baseline molecular status of archival tumor (c-met amplification and mutation status) [ Time Frame: Baseline ]Will correlate with clinical response.
- Overall survival [ Time Frame: Time from start of treatment to time of death, assessed up to 4 years ]Will correlate with clinical response.
- Pharmacodynamic responses in levels of soluble, circulating angiogenic factors [ Time Frame: Baseline and day 1 of course 2 ]Will correlate with clinical response.
|Actual Study Start Date:||April 29, 2013|
|Estimated Primary Completion Date:||December 31, 2017 (Final data collection date for primary outcome measure)|
Experimental: Treatment (cabozantinib-s-malate)
Patients receive cabozantinib-s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Cabozantinib S-malate
Other Names:Other: Laboratory Biomarker Analysis
Correlative studiesOther: Pharmacological Study
I. Determine efficacy of single agent cabozantinib-s-malate (cabozantinib) in women previously receiving one line of chemotherapy for metastatic endometrial cancer or with progression within 12 months of completing adjuvant therapy, with co-primary endpoints of objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and progression-free-survival at 12 weeks (PFS).
I. Correlation of clinical response with baseline molecular status of archival tumor (hepatocyte growth factor receptor [c-met] amplification & mutation status) and overall survival.
Patients receive cabozantinib-s-malate orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 4 weeks or every 6 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01935934
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010|
|USC / Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|University of California Davis Comprehensive Cancer Center|
|Sacramento, California, United States, 95817|
|City of Hope South Pasadena|
|South Pasadena, California, United States, 91030|
|United States, Illinois|
|University of Chicago Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60637|
|Decatur Memorial Hospital|
|Decatur, Illinois, United States, 62526|
|NorthShore University HealthSystem-Evanston Hospital|
|Evanston, Illinois, United States, 60201|
|Southern Illinois University School of Medicine|
|Springfield, Illinois, United States, 62702|
|United States, Indiana|
|Indiana University/Melvin and Bren Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|Wayne State University/Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|UPMC-Magee Womens Hospital|
|Pittsburgh, Pennsylvania, United States, 15213|
|Tom Baker Cancer Centre|
|Calgary, Alberta, Canada, T2N 4N2|
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Juravinski Cancer Centre at Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8V 5C2|
|Cancer Centre of Southeastern Ontario at Kingston General Hospital|
|Kingston, Ontario, Canada, K7L 5P9|
|London Regional Cancer Program|
|London, Ontario, Canada, N6A 4L6|
|Ottawa Hospital and Cancer Center-General Campus|
|Ottawa, Ontario, Canada, K1H 8L6|
|University Health Network-Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Neesha Dhani||University Health Network-Princess Margaret Hospital|