Tesetaxel Plus 3 Different PD-(L)1 Inhibitors in Patients With Triple-Negative MBC and Tesetaxel Monotherapy in Patients With HER2-Negative MBC

Part of paid clinical trials in Fort Myers, Florida.

Sponsor
Odonate Therapeutics, Inc.
Study ID
NCT03952325
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Tesetaxel — DRUG
    Tesetaxel at 27 mg/m2 orally Q3W
  • Tesetaxel — DRUG
    Tesetaxel at 27 mg/m2 orally Q3W
  • Tesetaxel — DRUG
    Tesetaxel at 27 mg/m2 orally Q3W
  • Nivolumab — DRUG
    Nivolumab at 360 mg by intravenous infusion Q3W
  • Pembrolizumab — DRUG
    Pembrolizumab at 200 mg by intravenous infusion Q3W
  • Atezolizumab — DRUG
    Atezolizumab at 1,200 mg by intravenous infusion Q3W
  • Tesetaxel — DRUG
    Tesetaxel at 27 mg/m2 orally Q3W

Study Details

CONTESSA TRIO is a multi-cohort, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). In Cohort 1, approximately 200 patients with triple-negative MBC who have not received prior chemotherapy for advanced disease will be randomized 1:1:1 to receive tesetaxel plus either: (1) nivolumab; (2) pembrolizumab; or (3) atezolizumab. The primary efficacy endpoints for Cohort 1 are objective response rate (ORR) and progression free survival (PFS) in patients with programmed death-ligand 1 (PD-L1) positive status. In Cohort 2, approximately 60 elderly patients with human epidermal growth factor receptor 2 (HER2) negative MBC who have not received prior chemotherapy for advanced disease will receive tesetaxel monotherapy. The primary efficacy endpoints for Cohort 2 are ORR and PFS in patients with hormone receptor (HR)-positive, HER2-negative disease. In Cohort 3, approximately 60 non-elderly adult patients with HER2-negative MBC who have not received prior chemotherapy for advanced disease will receive tesetaxel monotherapy. The primary efficacy endpoints for Cohort 3 are ORR and PFS in patients with HR positive, HER2-negative disease.

Key Dates

Start date
Jul 9, 2019
Status verified
Jul 2021
Primary completion
Jun 23, 2021
Completion
Jun 23, 2021

Study Design

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

Arms

  • Experimental: Cohort 1, Arm A: Tesetaxel plus nivolumab
  • Experimental: Cohort 1, Arm B: Tesetaxel plus pembrolizumab
  • Experimental: Cohort 1, Arm C: Tesetaxel plus atezolizumab
  • Experimental: Cohort 2: Tesetaxel
  • Experimental: Cohort 3: Tesetaxel

Primary Outcome Measure

Cohort 1: ORR in patients with PD-L1 positive status [ Time Frame: Approximately 2.0-3.0 years ]

Locations (9)

FacilityCityStateZIPSite coordinators
Sarah Cannon Research Institute - Florida Cancer SpecialistsFort MyersFlorida33901-
Florida Cancer Specialists and Research InstituteSt. PetersburgFlorida33705-
Florida Cancer Specialists and Research Institute - Panhandle RegionTallahasseeFlorida32308-
Florida Cancer Specialists and Research InstituteWest Palm BeachFlorida33401-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
New York Cancer and Blood SpecialistsEast SetauketNew York11733-
West Cancer CenterGermantownTennessee38138-
Texas Oncology - Baylor Charles A. Sammons Cancer CenterDallasTexas75246-
Virginia Oncology AssociatesNorfolkVirginia23502-

Find similar trials in Fort Myers, FL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Sarah Cannon Research Institute - Florida Cancer Specialists· Fort Myers, FLFlorida Cancer Specialists and Research Institute· St. Petersburg, FLFlorida Cancer Specialists and Research Institute - Panhandle Region· Tallahassee, FLFlorida Cancer Specialists and Research Institute· West Palm Beach, FLDana-Farber Cancer Institute· Boston, MANew York Cancer and Blood Specialists· East Setauket, NY

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