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

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment closed, study ongoing Eligibility criteria expanded, about 23 words · Study sites revised (16) Show 2 more changesShow less
    • Eligibility criteria expanded, about 23 words
    • Study sites revised (16)
  2. Re-verified, no change to tracked fieldsv10
  3. Trial status: Active, Not Recruiting to Recruiting Primary completion date: Aug 9, 2026 to Dec 31, 2027 · Primary endpoints revised (3) · Enrollment target: 155 to 190 · 9 morev9 Show 12 more changesShow less
    • Primary completion date: Aug 9, 2026 to Dec 31, 2027
    • Primary endpoints revised (3)
    • Enrollment target: 155 to 190
    • Completion date: Sep 9, 2026 to Jan 31, 2028
    • Interventions: Alpelisib (Drug), Everolimus (Drug), Palazestrant (Drug), Ribociclib (Drug) to Alpelisib (Drug), Atirmociclib (Drug), Everolimus (Drug), Palazestrant (Drug), Ribociclib (Drug)
    • Eligibility criteria expanded, about 58 words
    • Secondary endpoints revised (3)
    • Study description expanded, about 59 words
    • Site details revised at 16 of 16 sites
    • Collaborators: 1 to 2
    • Study arms: 3 to 4
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  4. Primary endpoints revised (3) Trial status: Recruiting to Active, Not Recruiting · Primary completion date: May 20, 2026 to Aug 9, 2026 · Completion date: Jun 30, 2026 to Sep 9, 2026 · 6 morev8 Show 9 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: May 20, 2026 to Aug 9, 2026
    • Completion date: Jun 30, 2026 to Sep 9, 2026
    • Interventions: Alpelisib (Drug), Everolimus (Drug), OP-1250 (Drug), Ribociclib (Drug) to Alpelisib (Drug), Everolimus (Drug), Palazestrant (Drug), Ribociclib (Drug)
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints revised (3)
    • Study description revised
    • Site details revised at 16 of 16 sites
    • Study title expanded, about 10 words

    See this version in full on ClinicalTrials.gov ↗

  5. Enrollment target: 90 to 155 Primary completion date: Aug 31, 2024 to May 20, 2026 · Primary endpoints revised (3) · Completion date: Aug 31, 2024 to Jun 30, 2026 · 7 morev7 Show 10 more changesShow less
    • Primary completion date: Aug 31, 2024 to May 20, 2026
    • Primary endpoints revised (3)
    • Completion date: Aug 31, 2024 to Jun 30, 2026
    • Interventions: Alpelisib (Drug), OP-1250 (Drug), Ribociclib (Drug) to Alpelisib (Drug), Everolimus (Drug), OP-1250 (Drug), Ribociclib (Drug)
    • Eligibility criteria expanded, about 115 words
    • Secondary endpoints revised (3)
    • Site details revised at 1 of 16 sites
    • Study arms: 2 to 3
    • Study description expanded, about 5 words
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

Show 5 earlier versionsHide 5 earlier versions
  1. Enrollment target: 60 to 90 Eligibility criteria expanded, about 20 wordsv6 Show 1 more changeShow less
    • Eligibility criteria expanded, about 20 words

    See this version in full on ClinicalTrials.gov ↗

  2. Site details revised at 1 of 16 sitesv5
  3. Study sites: 7 to 16v4
  4. Primary endpoints: 2 to 3 Study sites: 1 to 7 · Secondary endpoints: 2 to 3v3 Show 2 more changesShow less
    • Study sites: 1 to 7
    • Secondary endpoints: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  5. Trial status: Not Yet Recruiting to Recruiting Primary endpoints revised (2) · Study sites: 0 to 1 · Secondary endpoints revised (2) · 1 morev2 Show 4 more changesShow less
    • Primary endpoints revised (2)
    • Study sites: 0 to 1
    • Secondary endpoints revised (2)
    • Study title shortened, about 7 words

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a Phase 1b open-label, 2-part study in 4 treatment groups. The 4 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.
Trial Details
NCT Number NCT05508906
Lead Sponsor Olema Pharmaceuticals, Inc.
Collaborators: Novartis, Pfizer
Conditions Metastatic Breast Cancer, ER-positive Breast Cancer, HER2-negative Breast Cancer, Breast Cancer, Locally Advanced Breast Cancer
Enrollment 190 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov