Trametinib With or Without GSK2141795 in Treating Patients With Recurrent or Persistent Endometrial Cancer

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01935973
Phase
PHASE1
Status
Completed

Conditions

  • Endometrial Adenocarcinoma
  • Endometrial Clear Cell Adenocarcinoma
  • Endometrial Mixed Cell Adenocarcinoma
  • Endometrial Serous Adenocarcinoma
  • Endometrial Undifferentiated Carcinoma
  • Recurrent Uterine Corpus Cancer

Eligibility Criteria

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

Interventions

  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Trametinib — DRUG
    Given PO
  • Uprosertib — DRUG
    Given PO

Study Details

This randomized phase I trial studies how well trametinib with or without GSK 2141795 (protein kinase B \[Akt\] inhibitor GSK2141795) works in treating patients with endometrial cancer that has come back (recurrent) or does not go to remission despite treatment (persistent). Trametinib and Akt inhibitor GSK2141795 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether trametinib is a more effective treatment for endometrial cancer when given with or without ATK inhibitor GSK2141795.

Key Dates

Start date
Sep 30, 2013
Status verified
Oct 2020
Primary completion
Sep 8, 2015
Completion
Sep 8, 2015

Study Design

Enrollment
26 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm I (trametinib)
    Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving disease progression may cross over to Arm II.
  • Experimental: Arm II (trametinib and Akt inhibitor GSK2141795)
    Patients receive trametinib PO QD and Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

PFS by regimen administered using RECIST version 1.1 (Phase II) [ Time Frame: The duration of time from study entry to time of progression or death, whichever occurs first, assessed up to 5 years ]

Locations (22)

FacilityCityStateZIPSite coordinators
Hartford HospitalHartfordConnecticut06102-
The Hospital of Central ConnecticutNew BritainConnecticut06050-
Augusta University Medical CenterAugustaGeorgia30912-
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637-
University of Kentucky/Markey Cancer CenterLexingtonKentucky40536-
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287-
Washington University School of MedicineSt LouisMissouri63110-
University of New Mexico Cancer CenterAlbuquerqueNew Mexico87102-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Carolinas Medical Center/Levine Cancer InstituteCharlotteNorth Carolina28203-
Case Western Reserve UniversityClevelandOhio44106-
Cleveland Clinic FoundationClevelandOhio44195-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
Hillcrest Hospital Cancer CenterMayfield HeightsOhio44124-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-
Women and Infants HospitalProvidenceRhode Island02905-
Medical University of South CarolinaCharlestonSouth Carolina29425-
M D Anderson Cancer CenterHoustonTexas77030-
University of Virginia Cancer CenterCharlottesvilleVirginia22908-
Virginia Commonwealth University/Massey Cancer CenterRichmondVirginia23298-

Find similar trials in Hartford, CT

By research site
Hartford Hospital· Hartford, CTThe Hospital of Central Connecticut· New Britain, CTAugusta University Medical Center· Augusta, GAUniversity of Chicago Comprehensive Cancer Center· Chicago, ILUniversity of Kentucky/Markey Cancer Center· Lexington, KYJohns Hopkins University/Sidney Kimmel Cancer Center· Baltimore, MD

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