Cabozantinib S-Malate in Treating Patients With Recurrent or Metastatic Endometrial Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01935934
Phase
PHASE2
Status
Completed

Conditions

  • Endometrial Adenosquamous Carcinoma
  • Endometrial Clear Cell Adenocarcinoma
  • Endometrial Mixed Cell Adenocarcinoma
  • Endometrial Serous Adenocarcinoma
  • Metastatic Endometrioid Adenocarcinoma
  • Recurrent Malignant Uterine Corpus Neoplasm
  • Stage IV Uterine Corpus Carcinoma or Carcinosarcoma by AJCC v7 Stage
  • Stage IVA Uterine Corpus Carcinoma or Carcinosarcoma by AJCC v7 Stage
  • Stage IVB Uterine Corpus Carcinoma or Carcinosarcoma by AJCC v7 Stage
  • Uterine Corpus Carcinosarcoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cabozantinib S-malate — DRUG
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pharmacological Study — OTHER
    Correlative studies

Study Details

This phase II trial studies how well cabozantinib s-malate works in treating patients with endometrial cancer that has come back (recurrent) or has spread to other places in the body (metastatic). Cabozantinib s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Key Dates

Start date
May 8, 2013
Status verified
Sep 2025
Primary completion
Sep 12, 2019
Completion
Oct 24, 2024

Study Design

Enrollment
102 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (cabozantinib s-malate)
    Patients receive 60 mg cabozantinib s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Response Rate [ Time Frame: At 12 weeks, then every 8 weeks during treatment; up to 12 weeks post-treatment if discontinued due to toxicities, a maximum of 16 weeks ]

Locations (12)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
Los Angeles General Medical CenterLos AngelesCalifornia90033-
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
City of Hope South PasadenaSouth PasadenaCalifornia91030-
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637-
Decatur Memorial HospitalDecaturIllinois62526-
NorthShore University HealthSystem-Evanston HospitalEvanstonIllinois60201-
Southern Illinois University School of MedicineSpringfieldIllinois62702-
Indiana University/Melvin and Bren Simon Cancer CenterIndianapolisIndiana46202-
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
UPMC-Magee Womens HospitalPittsburghPennsylvania15213-

Find similar trials in Duarte, CA

By research site
City of Hope Comprehensive Cancer Center· Duarte, CALos Angeles General Medical Center· Los Angeles, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CACity of Hope South Pasadena· South Pasadena, CAUniversity of Chicago Comprehensive Cancer Center· Chicago, ILDecatur Memorial Hospital· Decatur, IL

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