A Phase II, Two-Arm Study of Everolimus and Letrozole, +/- Ribociclib (Lee011) in Patients With Advanced or Recurrent Endometrial Carcinoma

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03008408
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Recurrent Endometrial Carcinoma
  • Recurrent Endometrial Endometrioid Adenocarcinoma
  • Refractory Endometrial Carcinoma
  • Refractory Endometrial Endometrioid Adenocarcinoma
  • Stage III Uterine Corpus Cancer AJCC v8
  • Stage IIIA Uterine Corpus Cancer AJCC v8
  • Stage IIIB Uterine Corpus Cancer AJCC v8
  • Stage IIIC Uterine Corpus Cancer AJCC v8
  • Stage IIIC1 Uterine Corpus Cancer AJCC v8
  • Stage IIIC2 Uterine Corpus Cancer AJCC v8
  • Stage IV Uterine Corpus Cancer AJCC v8
  • Stage IVA Uterine Corpus Cancer AJCC v8
  • Stage IVB Uterine Corpus Cancer AJCC v8

Eligibility Criteria

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

Interventions

  • Everolimus — DRUG
    Given PO
  • Letrozole — DRUG
    Given PO
  • Ribociclib — DRUG
    Given PO

Study Details

This phase II trial studies how well everolimus and letrozole with or without ribociclib work in treating participants with endometrial cancer that has spread to other areas of the body or has come back. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs such as everolimus and letrozole have been shown to be effective at stopping tumor growth either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ribociclib, everolimus, and letrozole may work better than everolimus and letrozole in treating participants with endometrial cancer.

Key Dates

Start date
Aug 18, 2017
Status verified
May 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
90 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (ribociclib, everolimus, letrozole)
    Patients receive ribociclib PO QD, everolimus PO QD, and letrozole PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm II (everolimus, letrozole)
    Patients receive everolimus PO QD and letrozole PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Clinical benefit rate (CBR) [ Time Frame: At 8 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
Lyndon Baines Johnson General HospitalHoustonTexas77026-1967-
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By research site
Lyndon Baines Johnson General Hospital· Houston, TXM D Anderson Cancer Center· Houston, TX

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