Ribociclib and Letrozole Treatment in Ovarian Cancer

Part of paid clinical trials in San Francisco, California.

Sponsor
Gynecologic Oncology Group
Study ID
NCT03673124
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Low Grade Serous Carcinoma

Eligibility Criteria

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

Interventions

  • Ribociclib — DRUG
    600 mg by mouth daily for 21 days followed by 7 days off treatment
  • Letrozole — DRUG
    2.5 mg by mouth daily

Study Details

The study evaluates the response to treatment with Ribociclib and Letrozole in patients with low grade serous cancer of the ovary, fallopian tube or peritoneum.

Key Dates

Start date
May 20, 2019
Status verified
Dec 2025
Primary completion
Dec 23, 2024
Completion
Dec 31, 2026

Study Design

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

Arms

  • Other: Ribociclib and letrozole
    Ribociclib 600mg oral daily for 3 weeks then 1 week off plus Letrozole 2.5 mg oral daily

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Every 3 cycles during treatment period and at least 4 weeks after the first observation of a complete or partial response assessed up to approximately 55.9 months. The average study treatment time was 16.4 months. ]

Locations (27)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94158-
UF HeathGainesvilleFlorida32610-
Moffitt Cancer CenterTampaFlorida33612-
Northside HospitalAtlantaGeorgia30342-
NorthShore University HealthSystemEvanstonIllinois60201-
Saint Vincent Hospital and Health Care Center, Inc.IndianapolisIndiana46260-
St. Joseph Mercy Hospital Cancer Care CenterAnn ArborMichigan48106-
Mayo Clinic - RochesterRochesterMinnesota55905-
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire05055-
Hackensack University Medical CenterHackensackNew Jersey07601-
The Valley Hospital Inc.RidgewoodNew Jersey07540-
New Mexico Cancer Care Alliance/University of New Mexico Comprehensive Cancer CenterAlbuquerqueNew Mexico87008-
Southwest Gynecologic Oncology AssociatesAlbuquerqueNew Mexico87008-
Miami Valley HospitalCentervilleOhio45459-
The Ohio State Comprehensive Cancer CenterColumbusOhio43210-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
Oklahoma Cancer Care Specialists and Research Institute , LLCTulsaOklahoma74146-
Western Pennsylvania Hospital/West Penn HospitalPittsburghPennsylvania15224-
Abington Memorial HospitalWillow GrovePennsylvania19090-
Women & Infants HospitalProvidenceRhode Island02905-
Parkland Health and Hospital SystemDallasTexas75235-
University of Texas Southwestern Medical CenterDallasTexas75390-
Houston Methodist HospitalHoustonTexas77479-
Houston Methodist Willowbrook HospitalHoustonTexas77070-
MD Anderson Cancer CenterHoustonTexas77030-
Memorial Hermann Texas Medical Center - Texas Medical CenterHoustonTexas77030-
Houston Methodist Sugar Land HospitalSugar LandTexas77479-

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