Randomized Phase 2 Study of Atezolizumab and Entinostat in Patients With aTN Breast Cancer With Phase 1b Lead In

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Syndax Pharmaceuticals
Study ID
NCT02708680
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Entinostat — DRUG
    An orally available histone deacetylases inhibitor (HDAC).
  • Atezolizumab — DRUG
    A humanized, engineered monoclonal antibody of IgG1 isotype against the protein programmed cell death ligand 1 (PD-L1).
  • Placebo — DRUG
    A pill containing no active drug ingredient

Study Details

The purpose of this study is to determine the safety and tolerability of entinostat used in combination with atezolizumab in participants with Advanced Triple Negative Breast Cancer (aTNBC). Additionally, the purpose of the study is to assess how effective entinostat and atezolizumab are in combination in participants with aTNBC.

Key Dates

Start date
May 31, 2016
Status verified
Nov 2024
Primary completion
Mar 31, 2021
Completion
Mar 31, 2021

Study Design

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

Arms

  • Active Comparator: Entinostat plus Atezolizumab
    Participants in this arm will receive entinostat in combination with atezolizumab. Phase 1b Dose Determination: The initial 3 to 6 participants will receive entinostat at a starting dose of 5 milligrams (mg) (Dose Group 1) on Days 1, 8, and 15 along with atezolizumab 1200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle. If the 5 mg dose exceeds the maximum tolerated dose (MTD), then a 3 mg dose of entinostat (Dose Group -1) will be evaluated in the same manner. If the -1 dose level exceeds the MTD, then a 2 mg dose of entinostat (Dose Group -2) will be evaluated. Phase 2 Dose Expansion: Participants will receive the RP2D identified in the Dose Determination Phase.
  • Placebo Comparator: Placebo plus Atezolizumab
    Participants in this arm will receive placebo in combination with atezolizumab 1200 mg.

Primary Outcome Measure

Phase 1b: Participants Experiencing DLT [ Time Frame: Up to 21 days after Cycle 1 Day 1 ]

Locations (19)

FacilityCityStateZIPSite coordinators
UAB Comprehensive Cancer CenterBirminghamAlabama35201-
CBCC Global Research at Comprehensive Blood and Cancer CenterBakersfieldCalifornia93309-
St. Jude Medical CenterFullertonCalifornia92835-
Los Angeles Hematology Oncology Medical GroupGlendaleCalifornia91204-
Torrance Memorial Cancer Care AssociatesRedondo BeachCalifornia90277-
SLO Oncology and Hematology Health CenterSan Luis ObispoCalifornia93401-
Central Coast Medical Oncology GroupSanta MariaCalifornia93454-
UCLA Hematology/Oncology - Santa MonicaSanta MonicaCalifornia90404-
Saint Mary's Regional Cancer CenterGrand JunctionColorado81501-
Office of Human ResearchHollywoodFlorida33020-
Orlando Health, Inc.OrlandoFlorida32806-
Ft. Wayne Hematology and OncologyFort WayneIndiana46804-
Ft. Wayne Medical Oncology & Hematology, IncFort WayneIndiana46845-
Cancer Center of KansasWichitaKansas67214-
Frauenshuh Cancer Center at Park Nicollet Health ServiceSaint Louis ParkMinnesota55426-
Saint Barnabas Medical Cancer CenterLivingstonNew Jersey07039-
Hope Women's Cancer CentersAshevilleNorth Carolina28806-
Wake Forest Baptist Medical CenterWinston-SalemNorth Carolina27157-
Texas Oncology-Baylor Charles A. Sammons Cancer CenterDallasTexas75201-

Find similar trials in Birmingham, AL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
UAB Comprehensive Cancer Center· Birmingham, ALCBCC Global Research at Comprehensive Blood and Cancer Center· Bakersfield, CASt. Jude Medical Center· Fullerton, CALos Angeles Hematology Oncology Medical Group· Glendale, CATorrance Memorial Cancer Care Associates· Redondo Beach, CASLO Oncology and Hematology Health Center· San Luis Obispo, CA

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