Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Olema Pharmaceuticals, Inc.
Study ID
NCT05508906
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Palazestrant — DRUG
    Complete estrogen receptor antagonist (CERAN)
  • Ribociclib — DRUG
    All subjects in Treatment Group 1 will receive palazestrant in combination with ribociclib.
  • Alpelisib — DRUG
    All subjects in Treatment Group 2 will receive palazestrant in combination with alpelisib.
  • Everolimus — DRUG
    All subjects in Treatment Group 3 will receive palazestrant in combination with everolimus.
  • Atirmociclib — DRUG
    All subjects in Treatment Group 4 will receive palazestrant in combination with atirmociclib.

Study Details

This is a Phase 1b open-label, 2-part study in 3 treatment groups. The 3 treatment groups are as follows: Treatment Group 1: Palazestrant (OP-1250) in combination with ribociclib (KISQALI®, Novartis Pharmaceuticals Corporation). Treatment Group 2: Palazestrant (OP-1250) in combination with alpelisib (PIQRAY®, Novartis Pharmaceuticals Corporation). Treatment Group 3: Palazestrant (OP-1250) in combination with everolimus. Treatment Group 4: Palazestrant (OP-1250) in combination with atirmociclib.

Key Dates

Start date
Aug 31, 2022
Status verified
Oct 2025
Primary completion
Dec 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
190 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Palazestrant with Ribociclib
    Treatment Group 1: Palazestrant in combination with ribociclib (KISQALI®, Novartis Pharmaceuticals Corporation).
  • Experimental: Palazestrant with Alpelisib
    Treatment Group 2: Palazestrant in combination with alpelisib (PIQRAY®, Novartis Pharmaceuticals Corporation)
  • Experimental: Palazestrant with Everolimus
    Treatment Group 3: Palazestrant in combination with everolimus
  • Experimental: Palazestrant with Atirmociclib
    Treatment Group 4: Palazestrant in combination with atirmociclib

Primary Outcome Measure

Dose Limiting Toxicities (DLTs) [ Time Frame: The first 28 days of treatment ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Cancer CenterGilbertArizona85234
Research Coordinator
University of California San Francisco HealthSan FranciscoCalifornia94158
Research Coordinator
University of Colorado Cancer CenterAuroraColorado80045
Research Coordinator
Advent Health Hematology and OncologyOrlandoFlorida32804
Research Coordinator
University of IowaIowa CityIowa52242
Research Coordinator
Dana Farber Cancer InstituteBostonMassachusetts02215
Research Coordinator
Henry Ford HealthDetroitMichigan48126
Research Coordinator
Regents of the University of MinnesotaMinneapolisMinnesota55455
Research Coordinator
Washington University, School of MedicineSt LouisMissouri63110
Research Coordinator
Ichan School of Medicine at Mount SinaiNew YorkNew York10029
Research Coordinator
Atrium Health Levine Cancer InstituteCharlotteNorth Carolina28204
Research Coordinator
Henry-Joyce Cancer Clinic, The Vanderbilt ClinicNashvilleTennessee37232
Research Coordinator
MD Anderson Cancer CenterHoustonTexas77030
Research Coordinator
Northwest Medical SpecialtiesTacomaWashington98405
Research Coordinator

Find similar trials in Gilbert, AZ

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Banner MD Anderson Cancer Center· Gilbert, AZUniversity of California San Francisco Health· San Francisco, CAUniversity of Colorado Cancer Center· Aurora, COAdvent Health Hematology and Oncology· Orlando, FLUniversity of Iowa· Iowa City, IADana Farber Cancer Institute· Boston, MA

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